Issuu

Resources for You, Your Patients, & Your Practice

2022

BUYERS GUIDE

Round up SARS-CoV-2 and 18 other pathogens. The new BioFire Respiratory 2.1-EZ (RP2.1-EZ) Panel (EUA) covers SARS-CoV-2 detection and so much more. ®

Right now, SARS-CoV-2 is everyone’s top suspect, but many other respiratory bugs can cause similar, overlapping symptoms. Testing for just SARS-CoV-2 or influenza could mean running the risk of missing the real culprit, leading to missed infections, or even coinfections. Additionally, many rapid diagnostic tests sacrifice accuracy for speed, with sensitivities oftentimes ranging from 50–70%.2 Now you can test for 18 common respiratory pathogens in your clinic, including SARS-CoV-2 in patients suspected of a COVID-19 infection with syndromic testing from the BioFire RP2.1-EZ Panel— now available under an FDA Emergency Use Authorization (EUA).1,3 Syndromic testing means all it takes is one test and about 45 minutes to round up SARS-CoV-2—and all the other usual respiratory suspects. What's your frontline solution for respiratory season and beyond?

1000

BioFire RP2.1-EZ Panel (EUA) Overall 97.1% sensitivity and 99.3% specificity (prospective specimens)4 SARS-CoV-2 98.0% sensitivity and 100% specificity (archived specimens)5 SARS-CoV-2 100% PPA and 100% NPA (contrived specimens)6

1. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of invitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 2. http://www.cdc.gov/flu/professionals/diagnosis/rapidlab.htm 3. For use with the CLIA-waived BioFire® FilmArray® 2.0 EZ configuration. 4. Based on the prospective portion of the clinical study for the BioFire® FilmArray® Respiratory 2 (RP2) Panel. 5. Based on the archived specimen study in the BioFire Respiratory 2.1 (RP2.1) Panel EUA submission 6. Based on the contrived specimen study in the BioFire Respiratory 2.1 (RP2.1) Panel EUA submission.

BFR0001-0517-02

To learn more, visit biofiredx.com

PUBLISHED BY Medical Education Resources, LLC PUBLISHER Aaron R. Medaris amedaris@physiciansofficeresource.com

CEO Andrew C. Nimmo acnimmo@physiciansofficeresource.com

PRESIDENT John D. Pasquale jpasquale@pharmaconnect.com

BUSINESS MANAGER Marci J. Hills mhills@physiciansofficeresource.com

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To continue your free subscription of Physicians Office Resource magazine, please fill out the Business Reply Card (BRC) located within this magazine and drop in any United States Post Office mailbox. If you are a manufacturer of medical products or provide services to medical professionals and would like to advertise your products or services to the nation’s top physicians doing in-office testing, call 801-380-6094 or visit: POR.io for more information.

1. Go to www.PhysiciansOfficeResource.com and enter the four-digit reference number found next to the product or service into the search field, then request additional information, schedule a demo, or speak with a sales agent all with just a simple click of a button. 2. Find the Business Reply Card in this issue, circle the desired reference numbers, complete the form, and drop into any USPS mailbox. A representative will contact you as quickly as possible to answer your questions.

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2022 · BUYERS GUIDE | 3

CONTENTS

2022 BUYERS GUIDE

W H AT ’ S I N THIS GUIDE

2022 Medical Conferences

Diagnostics and Device Company Directory

4 | PHYSICIANS OFFICE RESOURCE

Health Agency Hotlines

Government Organizations

State Medical Associations

Companies by Category

Product Guide

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DIRECTORIES

MEDICAL CONFERENCES 2022

January American Association for Hand Surgery 2022 Annual Meeting January 11 – 15, 2022 Carlsbad, CA 978-927-8330 www.handsurgery.org American Society for Reconstructive Microsurgery Annual Meeting 2022 January 14 – 18, 2022 Carlsbad, CA 312-456-9579 www.microsurg.org CANS Annual Meeting 2022 California Association of Neurological Surgeons January 14 - 16, 2022 La Jolla, CA 916-457-2267 www.cans1.org STS Annual Meeting Society of Thoracic Surgeons January 29 – 31, 2022 Miami Beach, FL 312-202-5800 www.sts.org

February ORS 2022 Annual Meeting Orthopaedic Research Society February 4 – 8, 2022 Tampa, FL 847-823-5770 www.ors.org/2022annualmeeting/

6 | PHYSICIANS OFFICE RESOURCE

SCCM Critical Care Congress Society of Critical Care Medicine February 6 – 9, 2022 San Juan, PR 847-827-6888 www.sccm.org

SSO 2022 Annual Cancer Symposium Society of Surgical Oncology March 9 – 12, 2022 Dallas, TX 847-427-1400 www.surgonc.org

Biophysical Society Annual Meeting 2022 Biophysical Society February 19 – 23, 2022 San Francisco, CA 240-290-5600 www.biophysics.org/ 2022meeting

ASAPS Aesthetic Meeting 2022 The American Society for Aesthetic Plastic Surgery March 10 – 11, 2022 Dallas, TX 800-364-2147 www.surgery.org

2022 AAAAI Annual Meeting American Academy of Allergy Asthma & Immunology February 25 – 28, 2022 Phoenix, AZ 414-272-6071 www.annualmeeting.aaaai. org

2022 Annual HIMSS Conference & Exhibition Healthcare Information and Management Systems March 14 – 18, 2022 Orlando, FL 855-326-8342 www.himssconference.org

Pri-Med February 25-27, 2022 Orlando, FL 877-477-4633 www.pri-med.com

March AMGA Annual Conference 2022 American Medical Group Association March 9 – 12, 2022 Las Vegas, NV 703-838-0033 www.amga.org

SAGES 2022 Annual Meeting Society of American Gastrointestinal Endoscopic Surgeons March 16 – 19, 2022 Denver, CO 310-437-0544 www.sages2022.surgery

AAPM Annual Meeting American Academy of Pain Medicine March 17 – 20, 2022 Scottsdale, AZ 847-375-4731 www.annualmeeting.painmed.org

SGO 2022 Annual Meeting on Women’s Cancer Society of Gynecologic Oncologists March 18 – 21, 2022 Phoenix, AZ 312-235-4060 www.sgo.org

AORN Global Surgical Conference & Expo 2022 Association of Perioperative Registered Nurses March 19 – 23, 2022 New Orleans, LA 800-755-2676 www.aorn.org

AAOS Annual Meeting 2022 American Academy of Orthopaedic Surgeons March 22 –23, 2022 Chicago, IL 847-823-7186 www.aaos.org AAD Annual Meeting 2022 American Academy of Dermatology March 25 – 29, 2022 Boston, MA 866-503-7546 www.aad.org/meetings/ annual-meeting

April AAC 2022 Annual Scientific Session and Expo American College of Cardiology April 2 – 4, 2022 Washington, DC 800-253-4636 accscientificsession.acc.org

AAN Annual Meeting 2022 American Academy of Neurology April 2 – 7, 2022 Seattle, WA 800-879-1960 www.aan.com

Pri-Med Southwest 2022 April 5 – 7, 2022 Houston, TX 877-774-6338 www.pri-med.com

ASBS Annual Meeting 2022 American Society of Breast Surgeons April 6 – 10, 2022 Las Vegas, NV 877-992-5470 www.breastsurgeons.org

AACR Annual Meeting 2022 American Association of Cancer Research April 8 – 13, 2022 New Orleans, LA 866-423-3965 www.aacr.org

ACR Annual Meeting 2022 American College of Radiology April 24 – 28, 2022 Washington, DC 800-243-7419 www.acr.org/annual-meeting

ASLMS 2022 Annual Conference American Society for Laser Medicine & Surgery April 27 – 30, 2022 San Diego, CA 877-258-6028 www.aslms.org

ACP Internal Medicine Meeting 2022 American College of Physicians April 28 – 30, 2022 Chicago, IL 800-523-1546 annualmeeting.acponline. org

AANS Annual Scientific Meeting 2022 American Association of Neurological Surgeons April 29 – May 2, 2022 Philadelphia, PA 847-378-0500 www.aans.org

ASNR Annual Meeting & The Foundation of the ASNR Symposium 2022 American Society of Neuroradiology May 14 – 18, 2022 New York, NY 630-574-0220 www.asnr.org

May

AAO Annual Meeting 2022 American Academy of Ophthalmology May 21 – 24, 2022 Miami Beach, FL 415-561-8500 www.aao.org

ARRS Annual Meeting 2022 American Roentgen Ray Society May 1 – 5, 2022 New Orleans, LA 866-940-2777 www.arrs.org Pri-Med West 2022 May 5 – 7, 2022 Anaheim, California 877-774-6338 www.pri-med.com

ACOG 2022 Annual Clinical and Scientific Meeting American College of Obstetricians and Gynecologists May 6 – 8, 2022 San Diego, CA 800- 673-8444 www.acog.org

AACE 2022 Annual Scientific & Clinical Congress American Association of Clinical Endocrinologists May 12 – 14, 2022 San Diego, CA 904-353-7878 www.aace.com

ATS 2022 International Conference American Thoracic Society May 13 – 18, 2022 San Francisco, CA 212-315-8600 conference.thoracic.org

AATS Annual Meeting 2022 American Association for Thoracic Surgery May 14 – 17, 2022 Boston, MA 978-927-8330 www.aats.org

ACSM Annual Meeting American College of Sports Medicine May 31 – June 4, 2022 San Diego, CA 317-637-9200 www.acsm.org/annual-meeting/annual-home

June AMA Annual Meeting of House of Delegates 2022 American Medical Association June 11 – 15, 2022 Chicago, Illinois 800-621-8335 www.ama-assn.org

SNMMI 2022 Annual Meeting Society of Nuclear Medicine & Molecular Imaging June 11 – 14, 2022 Vancouver, BC 703-708-9000 www.snmmi.org

ENDO Annual Meeting 2022 The Endocrine Society June 11 – 14, 2022 Atlanta, GA 888-363-6274 www.endocrine.org

SIR 2022 Annual Scientific Meeting Society of Interventional Radiology June 11 – 16, 2022 Boston, MA 800-488-7284 www.SIRmeeting.org

APIC Annual Conference 2022 Association for Professional in Infection Control and Epidemiology June 13 – 15, 2022 Indianapolis, IN 202-789-1890 annual.apic.org

BIO International Convention 2022 Biotechnology Industry Organization June 13 – 16, 2022 San Diego, CA 202-962-6655 bio.org/

July AAPM Annual Meeting 2022 American Association of Physicists in Medicine July 10 – 14, 2022 Washington, DC 571-298-1300 www.aapm.org

AACC 2022 Annual Meeting & Clinical Lab Expo American Association for Clinical Chemistry July 24 – 28, 2022 Chicago, IL 800-892-1400 www.aacc.org

PDA Annual Meeting Pacific Dermatologic Association July 28 – 31, 2022 Portland, OR 888-388-8815 www.pacificderm.org

August AANA Annual Congress 2022 Arthroscopy Association of North America August 12 – 16, 2022 Chicago, IL 847-292-2262 www.aana.org

2022 · BUYERS GUIDE | 7

DIRECTORIES

September

NASS 2022 Annual Meeting North American Spine Society October 12 – 15, 2022 Chicago, IL 630-230-3600 www.spine.org

FMX 2022 American Academy of Family Physicians September 20 – 24, 2022 Washington, DC 800-274-2237 www.aafp.org

CHEST 2022 ACCP Annual Meeting American College of Chest Physicians October 16 –19, 2022 Nashville, TN 800-343-2227 www.chestnet.org

October ACEP Annual Scientific Assembly 2022 American College of Emergency Physicians October 1 – 4, 2022 San Francisco, CA 800-798-1822 www.acep.org

ASRM Scientific Congress and Expo 2022 American Society for Reproductive Medicine October 22 – 26, 2022 Anaheim, CA 205-978-5000 www.asrm.org

CNS Annual Meeting 2022 Congress of Neurological Surgeons October 12 – 15, 2022 Cincinnati, OH 847-240-2500 www.cns.org

The ANESTHESIOLOGY 2022 Annual Meeting American Society of Anesthesiologists October 22 – 26, 2022 New Orleans, LA 847-825-5586 www.asahq.org

ASTRO Annual Meeting 2022 American Society for Therapeutic Radiology & Oncology October 23 – 26, 2022 San Antonio, TX 703-502-1550 www.astro.org ASHG 2022 American Society of Human Genetics October 25 – 29, 2022 Los Angeles, CA 301-634-7300 www.ashg.org

ISPE Annual Meeting 2022 International Society for Pharmaceutical Engineering October 30 – November 2, 2022 Orlando, FL 301-364-9201 www.ispe.org

November ACAAI 2022 Annual Meeting American College of Allergy Asthma & Immunology November 10 – 14, 2022 Louisville, KY 847-427-1200 www.acaai.org

RSNA 2022 Scientific Assembly and Annual Meeting Radiological Society of North America November 27 – December 1, 2022 Chicago, Illinois 800-381-6660 www.rsna.org

December No Conferences Listed for December

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8 | PHYSICIANS OFFICE RESOURCE

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DIRECTORIES

DIAGNOSTIC + D E V I C E C O M PA N Y DIRECTORY A

Abbott Hematology 4551 Great America Parkway Santa Clara CA 95054 408-982-4850 www.abbottdiagnostics.com Abbott Point of Care 400 College Road East Princeton, NJ 08540 800-827-7828 www.pointofcare.abbott/us/ en/home Abbott Toxicology 829 Towne Center Dr. Pomona, CA 91767 888-831-6850 https://www.aleretoxicology.com/home.html Aerolase 777 Old Saw Mill River Road Tarrytown, NY 10591 914-345-8300 www.aerolase.com ALCOR Scientific Inc. 20 Thurber Blvd Smithfield, RI 02917 800-495-5270 www.alcorescientific.com Alfa Wassermann 4 Henderson Drive West Caldwell, NJ 07006 800-220-4488 www.alfawassermannus. com Allscripts 222 Merchandise Mart Plaza, Suite 2024 Chicago, IL 60654 800-334-8534 www.allscripts.com American Academy of Family Physicians 11400 Tomahawk Creek Parkway Leawood, KS 66211-2672 800-274-2237 www.aafp.org

10 | PHYSICIANS OFFICE RESOURCE

American Screening Corporation 7607 Fern Ave #703 & 704 Shreveport, LA 71105 844-677-7639 www.americanscreeningcorp.com AMS Alliance 1790 N. Commerce Pkwy Weston, FL 33326 1 (954) 217-0040 www.amsdiagnostics.com Arkray 5198 W. 76th Street Edina, MN 55439 800-818-8877 www.arkrayusa.com

BD Diagnostics 7 Loveton Circle Sparks, MD 21152 1-800-638-8663 www.bd.com Beckman Coulter 250 South Kraemer Blvd Brea, CA 92821 800-526-3821 www.beckmancoulter.com Bone Index Finland Ltd. 3710 Rawlins St., Suite 1420 Dallas, TX 75219 469-805-5419 www.bindex.us

Bionix Development Corporation 5154 Enterprise Blvd. Toledo, OH 43612 800-551-7096 www.bionix.com Bovie Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 800-537-2790 www.boviemedical.com The Brewer Company N88 W13901 Main Street, Suite 100 Menomonee Falls, WI 53051 888-273-9371 www.brewercompany.com

Cerner Corporation 2800 Rockcreek Parkway North Kansas City, MO 64117 816-221-1024 www.cerner.com Clarity Diagnostics 1060 Holland Dr., Suite A Boca Raton, FL 33487 877-722-6339 www.claritydiagnostics.com Clinical Diagnostics Solutions, Inc. 1800 NW 65th Avenue Plantation, FL 33313 954-791-1773 www.cdsolinc.com

Brilliant Medical Inc. P.O. Box 4456 Deerfield Beach, FL 33442 888-838-0432 www.brilliantmedical.com

COLA 9881 Broken Land Parkway Suite 200 Columbia, MD 21046-3016 800-981-9883 www.cola.org

Brymill Cryogenic Systems 105 Windermere Avenue Ellington, CT 06029 860-875-2460 www.brymill.com

CryoConcepts, LP 205 Webster Street Bethlehem, PA 18015 855-355-2796 Cryoconcepts.com

Cutera, Inc. 3240 Bayshore Boulevard Brisbane, CA 94005 415-657-5500 www.cutera.com

Cardiac Science N7 W22025 Johnson Drive Waukesha, WI 53186 855-366-0336 www.cardiacscience.com

BioFire Diagnostics 515 Colorow Drive Salt Lake City, UT 84108 800-735-6544 www.biofiredx.com

Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 888-838-3222 www.cepheid.com

Bio-Rad Laboratories 2000 Alfred Nobel Drive Hercules, CA 94547 800-424-6723 www.bio-rad.com

Carolina Liquid Chemistries 313 Gallimore Dairy Rd Greensboro, NC 27409 877-722-8910 www.carolinachemistries. com

The Daavlin Company 205 West Bement Street Bryan, OH 43506 800-322-8546 www.daavlin.com DermaMed Solutions, LLC 394 Parkmount Road P.O. Box 187 Lenni, PA 19052 610-358-4447 www.dermamedsolutions. com

Detecto 203 East Daugherty Street Webb City, MO 64870 800-641-2008 www.detecto.com DRG International 841 Mountain Ave. Springfield, NJ 07081 973-564-7555 www.drg-international.com Drucker Diagnostics 168 Bradford Drive Port Matilda, PA 16870 877-231-3115 www.druckerdiagnostics. com

ELITechGroup North America 370 West 1700 South Logan, UT 84321 800-354-8324 www.elitechgroup.com Erba Diagnostics, Inc. 2140 North Miami Ave. Miami, FL 33127 800-327-4565 www.erbadiagnostics.com Evoke Neuroscience 11 West 25th St., 10th Floor New York, NY 10010 917-261-6096 www.evokeneuroscience.com Exalenz Bioscience Inc. 35 Colby Avenue Suite 9 Manasquan, NJ 08736 1-888-392-5363 www.exalenz.com Exergen Corporation 400 Pleasant St. Watertown, MA 02472 1-800-422-3006 www.exergen.com

FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904 877-657-8118 www.sonosite.com Futuremed 15700 Devonshire Street Granada Hills, CA 91344 800-222-6780 www.futuremed.com

Greenway Health, LLC. 100 Greenway Blvd Carrollton, GA 30117 877.932.6301 www.greenwayhealth.com

H&O Equipments Inc. 4055 Faber Place Dr. North Charleston, SC 29405 888-248-2838 www.ho-equipments.com Heine North America 10 Innovation Way Dover, NH 03820 800-367-4872 www.heine.com Helena Laboratories 1530 Lindbergh Drive Beaumont, TX 77707 800-231-5663 www.helena.com Hemocue 250 South Kraemer Blvd. Mailstop: B1.SW.11 Brea, CA 92821 800-881-1611 www.hemocue.us Hemosure, Inc. 5358 Irwindale Ave., Unit A Irwindale, CA 91706 888-436-6787 www.hemosure.com Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 508-263-2900 www.hologic.com Horiba Medical 9755 Research Dr. Irvine, CA 92618 888- 903-5001 www.horiba.com/us/en/ medical Huntleigh Diagnostics 35 Portmanmoor Road Cardiff CF24 5HN Wales UK 800-323-1245 www.huntleigh-diagnostics. com

800-676-5565 www.jantdx.com Jones Medical Instrument Company 200 Windsor Drive Oak Brook, IL 60523 800-323-7336 www.jonesmedical.com

Korr Medical Technologies, Inc. 3487 W 2100 S, Building 300 Salt Lake City, UT 84119 800-895-4048 www.korr.com

Laboratory Consulting, LLC 1835 Hwy 45 N #315 Columbus, MS 39705 800-673-9251 www.onlinelabhelp.com LifeSign 85 Orchard Road Skillman, NJ 08558 800-526-2125 www.lifesignmed.com

Masimo 52 Discovery Irvine, CA 92618 800-326-4890 www.masimo.com Medica Corporation 5 Oak Park Drive Bedford, MA 01730 800-777-5983 www.medicacorp.com Medical Acoustics, LLC 640 Ellicott Street, 4th Floor Buffalo, NY 14203 888-820-0970 www.lungflute.com

Interson Corporation 7150 Koll Center Parkway Pleasanton, CA 94566 925-462-4948 www.interson.com

Medical Device Depot 3230 Bethany Lane, Suite 8 Ellicott City, MD 21042 877-646-3300 www.medicaldevicedepot. com

iSalus Healthcare 1 Virginia Avenue Suite 500 Indianapolis, IN 46204 888-280-6678 www.isalushealthcare.com

Meridian Bioscience 3471 River Hills Drive Cincinnati, OH 45244 978-856-2345 www.magellandx.com

MIR - Medical International Research 5462 S. Westridge Drive New Berlin, WI 53151 262-565-6797 www.spirometry.com

Jant Pharmacal 16530 Ventura Blvd., Suite 512 Encino, CA 91436

Medicus LIS 4555 NW 103rd Avenue Suite 105 Sunrise, FL 33351 888-643-8081 www.medicuslis.com Medpod 1460 Broadway New York, NY 10036 844-633-7631 www.medpodhealth.com MedTest 5449 Research Drive Canton, MI 48188 800-445-9853 www.medtest.com Mercedes Medical 7590 Commerce Court Sarasota, FL 34243 800-331-2716 www.mercedesmedical.com Micro Direct 803 Webster St. Lewiston, ME 04240 800-588-3381 www.mdspiro.com Midmark 1700 S. Patterson Blvd., Suite 400 Dayton, Ohio 45409 800-643-6275 www.midmark.com Mindray USA Corp. 800 MacArthur Blvd. Mahwah, NJ 07430 800-288-2121 www.mindraynorthamerica. com Morningside Medical Equipment 8970 Route 108 Suite C Columbia, MD 21045 800-675-1202 www.morningsidemedicalequipment.com My Inspection 4555 NW 103rd Avenue Suite 105 Sunrise, FL 33351 888-643-8081 www.myinspection.us

NanoEnTek 240 Bear Hill Road, Suite 101 Waltham, MA 02451 781-472-2558 www.nanoentek.com Nasiff Associates, Inc. 841 County Route 37, Suite 1 Central Square, NY 13036 866-627-4332 www.nasiff.com

2022 · BUYERS GUIDE | 11

DIRECTORIES

ndd Medical Technologies 300 Brickstone Square Suite 604 Andover, MA 01810 978-470-0923 www.nddmed.com NeuroMetrix, Inc. 1000 Winter Street Waltham, MA 02451 Phone (888) 786 7287 www.neurometrix.com Newman Medical 5350 Vivian St., Unit C Arvada, CO 80002 800-267-5549 www.newman-medical.com Nihon Kohden 90 Icon Street Foothill Ranch, CA 92610 800-325-0283 www.nihonkohden.com Nonin Medical 13700 1st Avenue North Plymouth, MN 55441 800-356-8874 www.nonin.com Nova Biomedical 200 Prospect Street Waltham, MA 02545 781-894-0800 www.novabio.us

Opti Medical, Inc. 235 Hembree Park Drive Rosewell, GA 30076 800-490-6784 www.optimedical.com OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 800-869-3538 www.orasure.com Ortho Clinical Diagnostics 1001 Route 202 Raritan, NJ 08869 800-828-6316 www.orthoclinical.com Ototronix 5000 Township Parkway Saint Paul, MN 55110 855-696-2986 www.ototronix.com Owen Mumford, Inc. 1755 West Oak Commons Court Marietta, GA 30062 770- 977- 2226 www.owenmumford.com/us/

12 | PHYSICIANS OFFICE RESOURCE

pts Diagnostics 7736 Zionsville Road Indianapolis, IN 46268 877-870-5610 www.ptsdiagnostics.com Phreesia 432 Park Ave. South, 12th Floor New York, NY 10016 888-654-7473 www.phreesia.com Physicians Office Resource A Division of Medical Education Resources, LLC 43 Golden Drive Bedford, NH 03110 603-472-9001 www.physiciansofficeresource. com Polestar Labs, Inc. 1223 Pacific Oaks Place, Ste. 102 Escondido, CA 92029 800-836-4848 www.polestarlabs.com Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567 800-431-2123 www.polymedco.com Premier Medical 1710 Romano Drive Plymouth Meeting, PA 19462 888-670-6100 www.premiermedicalco.com

Resmed Corporation 9001 Spectrum Center Blvd. San Diego, CA 92123 800-424-0737 www.resmed.com Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46250 800.428.5074 www.roche-diagnostics.us Schiller America, Inc. 10903 NW 33rd St. Doral, FL 33172 786-845-0620 www.schiller.ch/us SDI Diagnostics Ten Hampden Drive Easton, MA 02375 800-678-5782 www.sdidiagnostics.com Sekisui Diagnostics 4 Hartwell Place Lexington, MA 02421 781-652-7800 www.sekisuidiagnostics.com Sempermed USA 13900 49th St. North Clearwater, FL 33762 727-787-7250 www.sempermedusa.com SHL Telemedicine USA 90 Yigal Alon St. Tel Aviv 67891 Israel 972-3-5612212 www.shl-telemedicine.com

Quest Diagnostics 500 Plaza Drive Secaucus, NJ 07094 973-520-2700 www.questdiagnostics.com

Siemens Healthcare Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5097 800-743-6367 www.usa.siemens.com

Quidel 12544 High Bluff Dr., Suite 200 San Diego, CA 92130 858.552.1100 www.quidel.com

Smiths Medical 5200 Upper Metro Place, Suite 200 Dublin, OH 43017 800-258-5361 www.smiths-medical.com

R Radiometer America, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 800-736-0600 www.radiometeramerica.com Randox Laboratories LTD. 55 Diamond Road, Crumlin, County Antrim United Kingdom, BT29 4QY 866-472-6369 www.randox.com

Stanbio Laboratory 1261 North Main Street Boerne, TX 78006 800-531-5535 www.ekfusa.com Streck Labs 7002 S. 109th St. La Vista, NE 68128 800-228-6090 www.streck.com Syneron-Candela 3 Goodyear, Unit A Irvine, CA 92618 866-259-6661 www.syneron-candela.com

Sysmex America, Inc. 577 Aptakisic Rd. Lincolnshire, IL 60069 866-779-7639 www.sysmex.com/us

Tanita Corporation of America, Inc. 2625 South Clearbrook Drive Arlington Heights, IL 60005 847-640-9241 www.tanita.com Thermo Fisher Scientific 168 Third Avenue Waltham, MA 02451 800-678-5599 www.thermofisher.com Tosoh Bioscience 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080 800-248-6764 www.diagnostics.us.tosohbioscience.com Trinity Biotech 2823 Girts Rd. Jamestown, NY 14701 800-325-3424 www.trinitybiotech.com Tuttnauer USA Co. 25 Power Drive Hauppauge, NY 11788 800-624-5836 www.tuttnauerusa.com

Vinyl Crafters 47 West Frederick Street Walkersville, MD 21793 800-286-8738 www.vcupholstery.com Vitalograph 13310 W. 99th St. Lenexa, KS 66215 800-255-6626 www.vitalograph.com

Wallach Surgical 95 Corporate Dr. Trumbull, CT 06611 800-243-2463 www.wallachsurgical.com Welch Allyn 4341 State Street Road Skaneateles Falls, NY 13153 800-535-6663 www.welchallyn.com

Zanfel Laboratories, Inc. 1370 Northwest 114th St. #204 Clive, IA 50325 800-401-4002 www.zanfel.com

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COMPLETE LABORATORY SOLUTIONS From consultation, to licensure and compliance, the Abbott Clinical Lab Solutions team has you covered.

CONTACT ABBOTT CLINICAL LAB SOLUTIONS. CALL 888-831-6850 | EMAIL: CLS_SALES@ABBOTT.COM 1. Clinical Laboratory Improvement Amendments (CLIA) © 2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only. MKT52247 REV1 08/20

ASSESSING AND MONITORING COVID-19 PATIENTS. Urgent care facilities, primary care practices, and other outpatient settings at the front lines of the COVID-19 pandemic need on-site testing solutions to support patient assessment and monitoring. With-patient testing can lead to better healthcare performance by facilitating decisions that can optimize patient outcomes in real time, improving the quality of patient care. For facilities treating COVID-19 patients, having rapid, accurate diagnostic test results may be useful when assessing or monitoring patients for:

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• C-Reactive Protein (CRP) Levels may be elevated in COVID-19 cases, especially severe cases.2-15 • Liver, Kidney and Cardiac function Elevated levels of the following biomarkers may be indicators of COVID-19 severity:16-27 - Alanine Aminotransferase (ALT)16,17,20-27 - Albumin (ALB)16,19-22,25-27 - Aspartate Aminotransferase (AST)16,17,19-21,23-26 - Creatine Kinase (CK)16,18,20,22-24 - Creatinine (CREAT)16,22,23,25,27 - Total Bilirubin (TBILI)16,20,25,27

ON-SITE TESTING MADE EASY: PICCOLO XPRESS.® The Piccolo Xpress portable diagnostic analyzer offers a full complement of blood chemistry tests, including CLIA-waived tests. Get accurate results in minutes, at the point-of-care. SEE A LIST OF KEY PICCOLO XPRESS PANELS ON BACK.

For in vitro diagnostic use only. The Piccolo Xpress does not directly diagnose COVID-19.

KEY PICCOLO XPRESS PANELS. CLIA-WAIVED PANELS

MODERATELY COMPLEX PANELS

Comprehensive Metabolic Panel

BioChemistry Panel Plus

Na+, K+, CI-, tCO2, Ca, BUN, Crea, Glu,

ALB, ALP, ALT, AMY, AST, BUN, Ca,

ALB, ALP, ALT, AST, TP, tBIL, eGFR*

Crea, Glu, GGT, TP, UA, CRP, eGFR*

MetLyte 8

MetLyte Plus CRP

Na+, K+, Cl-, tCO2, BUN, Crea, Glu,

CK, eGFR*

CK, CRP, eGFR*

Liver Panel Plus

Hepatic Function Panel

ALB, ALP, ALT, AMY, AST, GGT,

ALB, ALP, ALT, AST, tBIL, dBIL, TP

tBIL, TP

*Calculated

To learn how the Piccolo Xpress portable diagnostic analyzer can help transform your patient care, contact your Abbott Point of Care Representative or visit www.pointofcare.abbott 1.

2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.

The Governing Board The American Association for the Study of Liver Diseases, Released: April 7, 2020. CLINICAL INSIGHTS FOR HEPATOLOGY AND LIVER TRANSPLANT PROVIDERS DURING THE COVID-19 PANDEMIC. Guan WJ et al. medRxiv preprint 2020; doi: https://doi.org/10. 1101/2020.02.06.20020974 Chen N et al. Lancet 2020; 395: 507–13 ; https://doi. org/10.1016/S0140-6736(20)30211-7 Cao W et al. medRxiv preprint 2020; doi: https://doi. org/10.1101/2020.02.23.20026963 Shi H et al. Lancet Infect Dis 2020 ; https://doi.org/10.1016/ S1473-3099(20)30086-4 Shi S et al. Jama Cardiology 2020; published online March 25; doi:10.1001/jamacardio.2020.0950 Xu H et al. medRxiv preprint 2020; doi: https://doi. org/10.1101/2020.03.05.20031591 Young BE et al. JAMA. Published online March 3, 2020; doi:10.1001/jama.2020.3204 Ruan Q et al. Intensive Care Medicine 2020. https://doi. org/10.1007/s00134-020-05991-x Zhou B. Research Square 2020; DOI:10.21203/rs.3.rs-18079/v1 Zhou S et al. AJR 2020; 215:1-8; doi.org/10.2214/AJR.20.22975 Li J et al. medRxiv preprint 2020; doi: https://doi. org/10.1101/2020.02.11.20022053 Deng SQ, Peng HJ. J. Clin. Med. 2020; 9, 575 (Review); doi:10.3390/jcm9020575 Ständiger Arbeitskreis der Kompetenz- und Behandlungszentren für Krankheiten durch hochpathogene Erreger am Robert Koch-Institut (STAKOB). Hinweise zu Erkennung, Diagnostik

15.

16.

17. 18.

19.

20.

21.

und Therapie von Patienten mit COVID-19; Downloaded 13. March 2020; www.rki.de/covid-19-therapie Chinese CoVID Management Guidelines-19, Version 7; published on 3/3/2020 by R.P.C. National Health Commission and the National Administration of Traditional Medicine of R.P.C.; translated by Jinwei Sun, Physician Specializing in Cardiovascular Disorders at the University of Milan-Bicocca Henry et al. 2020 Apr 10 Clinical Chemistry and Laboratory Medicine. Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 PMID: 32286245 DOI: 10.1515/cclm2020-0369. Ferrari et al. 2020 Apr 16 Clinical Chemistry and Laboratory Medicine. Routine blood tests as a potential diagnostic tool for COVID-19 PMID: 3230176 DOI: 10.1515/cclm-2020-0398. Yuan et al. 2020 Mar 29 Inflammation Research. The correlation between viral clearance and biochemical outcomes of 94 COVID-19 infected discharged patients PMID: 32227274 DOI: 10.1007/s00011-020-013242-0. Huang et al. 2020 Feb 15 The Lancet. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China PMID: 31986264 PMCID: PMC7159299 DOI: 10.1016/ S0140-6736(20) 30183-5. Chen et al. 2020 Feb 15 The Lancet. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study PMID: 32007143 PMCID: PMC7135076 DOI: 10.1016/S0140-6736(20)30211-7. The Governing Board The American Association for the Study of Liver Diseases, Released: April 7, 2020. CLINICAL IN

POINT OF CARE ©Abbott Point of Care Inc. 400 College Road East, Princeton, NJ 08540 (609) 454-9000 (609) 419-9370 (fax) www.pointofcare.abbott For in vitro diagnostic use only.

This material is intended for a U.S. audience only.

COVID-19 Channel Brochure - US 2994Rev.1 09/20 Piccolo Xpress is a registered trademark of Abaxis, Inc. and distributed by Abbott Point of Care. Abaxis 888-3354 Rev A

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SIGHTS FOR HEPATOLOGY AND LIVER TRANSPLANT PROVIDERS DURING THE COVID-19 PANDEMIC. Zhou et al. 2020 Mar 28 The Lancet. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study PMID 32171076 DOI: 10.1016/S0140-6736(20) 30566-3. Guan et al. 2020 Apr 30 The New England Journal of Medicine. The Clinical Characteristics of Coronavirus Disease 2019 in China PMID: 32109013 PMCID: PMC7092819 DOI: 10.1056/NEJMoa2002032. Holshue et al and The Washington State 2019-nCoV Case Investigation Team 2020 Mar 5 The New England Journal of Medicine Case Reports. First Case of 2019 Novel Coronavirus in the United States PMID: 32004427 PMCID: PMC7092802 DOI: 10.1056/NEJMoa2001191. Wu et al. 2020 Mar 13 JAMA Internal Medicine. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China PMID: 32167524 PMCID: PMC7070509 DOI: 10.1001/jamainternmed.2020.0994. Chen et al. 2020 May 1 The Journal of Clinical Investigation. Clinical and immunological features of severe and moderate coronavirus disease 2019 PMID: 32217835 PMCID: PMC7190990 (available on 2020-08-01) DOI: 10.1172/ JCI137244. Wang et al. 2020 Apr 23 The Journal of Clinical Investigation Insight. The laboratory tests and host immunity of COVID-19 patients with different severity of illness PMID: 32324595 DOI: 10.1172/jci.insight.137799.

DIRECTORIES

H E A LT H AGENCY HOTLINES

Adoption

National Adoption Center www.adopt.org (800) 862-3678

Aging

National Aging Info and Referral Support Center www.nasuad.org (202) 898-2578

Alcohol Abuse

Al-Anon Family Groups www.al-anon.alateen.org (757) 563-1600

Allergy/Asthma

American Academy of Allergy, Asthma & Immunology www.aaaai.org (414) 272-6071 FARE/ Food Allergy Research & Education www.foodallergy.org (800) 929-4040

Alzheimer’s Disease Alzheimer’s Association www.alz.org (800) 272-3900

Anemia

Aplastic Anemia & MDS International Foundation www.aamds.org (800) 747-2820 16 | PHYSICIANS OFFICE RESOURCE

Sickle Cell Disease Association of America, Inc. www.sicklecelldisease.org (800) 421-8453

Arthritis

Arthritis Foundation Info Hotline www.arthritis.org (844) 571-4357

Bladder Diseases

Interstitial Cystitis Association www.ichelp.org (703) 442-2070

Breast Disease

Fibromyalgia

Digestive Disorders/ Diseases

Gastrointestinal Diseases

National Breast & Cervical Cancer Early Detection Program www.cdc.gov/cancer/nbccedp (800) 232-4636

Crohn’s & Colitis Foundation of America www.ccfa.org (800) 932-2423 Celiac Disease Foundation www.celiac.org (818) 716-1513

National Fibromyalgia Association www.fmaware.org

International Foundation for Functional Gastrointestinal Disorders www.iffgd.org (414) 964-1799

Growth Disorders

Eating Disorders

Human Growth Foundation www.hgfound.org (800) 451-6434

National Bone Marrow Transplant Link www.nbmtlink.org (800) 546-5268

Eye Disease

International Hearing Society www.ihsinfo.org (734) 522-7200

Bone Disease

The Vision Council www.thevisioncouncil.org (866) 826-0290

American Heart Association www.heart.org (800) 242-8721

Blood Disorders

National Hemophilia Foundation www.hemophilia.org (212) 328-3700

National Eating Disorders Association www.nationaleatingdisorders.org (800) 931-2237

Hearing Disorders

Bone Marrow

National Institute of Arthritis & Musculoskeletal & Skin Diseases www.niams.nih.gov (877) 226-4267

American Macular Degeneration Foundation www.macular.org (888) 622-8527

Glaucoma Research Foundationwww.glaucoma.org (415) 986-3162

Heart Disease

Hepatitis C

Hepatitis C Association www.hepcassoc.org (908) 769-8479

Hospital/Hospice Care Caring Connections www.caringinfo.org (703) 837-1500

Minority Health

US Department of Health and Human Services Office of Minority Health www.minorityhealth.hhs.gov (800) 444-6472

Immunization

National Immunization Hotline www.cdc.gov/vaccines (800) 232-4636

Impotence

American Urological Association www.auanet.org (866) 746-4282

Insurance/Medicare/ Medicaid

Medicare Issues Hotline www.medicare.gov (800) 633-4227

Nervous System Disease

American Parkinson Disease Association www.apdaparkinson.org (800) 223-2732 Multiple Sclerosis Foundation www.msfocus.org (888) 673-6287 National Stroke Association www.stroke.org (800) 242-8721

Organ Donation Living Bank www.livingbank.org (800) 528-2971

Kidney Disease

National Kidney Foundation www.kidney.org (800) 622-9010

Lead

EPA Lead Information Center www.epa.gov/lead (800) 424-5323

Pancreatic Disease

Pancreatic Cancer Action Network www.pancan.org (877) 573-9971

Paralysis and Spinal Injury Christopher & Dana Reeve Foundation www.christopherreeve.org (800) 539-7309

Liver Diseases

American Liver Foundation www.liverfoundation.org (212) 668-1000

Lung Disease/ Asthma/Allergy

Parkinson’s Disease

Parkinson’s Disease Foundation www.parkinson.org (800) 473-4636

Pediatrics

American Lung Association www.lungusa.org (800) 586-4872

American Academy of Pediatrics www.aap.org (800) 433-9016

Mental Health

American Association of Poison Control Centers www.aapcc.org (800) 222-1222

Professionals

American Medical Association www.ama-assn.org (800) 622-3211

Surgery/Facial Plastic Surgery

American Society of Plastic Surgeons www.plasticsurgery.org (847) 228-9900

Rehabilitation

National Rehabilitation Info. Ctr. www.naric.com (800) 346-2742

Thyroid Disease

American Thyroid Association www.thyroid.org (703) 998-8890

Rheumatic Diseases Scleroderma Foundation www.scleroderma.org (800) 722-4673

Veterans

Sexually Transmitted Diseases

VA Suicide Prevention www.mentalhealth.va.gov (844) 698-2311

CDC Sexually Transmitted Diseases Info. www.cdc.gov/std/ (800) 232-4636

Veterans Special Issue Helpline Department of Veterans Affairs www.va.gov (844) 698-2311

Vision Disorders

Skin Disease

American Council of the Blind www.acb.org (800) 424-8666

National Psoriasis Foundation www.psoriasis.org (800) 723-9166

Spinal Diseases

National Scoliosis Foundation, Inc. www.scoliosis.org (800 )673-6922

Stroke

National Stroke Association www.stroke.org (800) 242-8721

Sudden Infant Death Syndrome American SIDS Institute www.sids.org (239) 431-5425

Poison Control

Mental Health America www.mentalhealthamerica.net (800) 969-6642

2022 · BUYERS GUIDE | 17

DIRECTORIES

GOVERNMENT O R G A N I Z AT I O N S

Agency for Healthcare Research and Quality (301) 427-1104 www.ahrq.gov

National Institute of Allergy and Infectious Diseases (866) 284-4107 www.niaid.nih.gov

National Institute of Diabetes and Digestive and Kidney Disease (800) 860-8747 www.niddk.nih.gov

National Institutes of Health (301) 496-4000 www.nih.gov

Center for Disease Control and Prevention (800) 232-4636 www.cdc.gov

National Institute of Arthritis and Musculoskeletal and Skin Disease (877) 226-4267 www.niams.nih.gov

National Institute of Environmental Health Sciences (919) 541-3345 www.niehs.nih.gov

Occupational Safety & Health Administration (800) 321-6742 www.osha.gov

Centers for Medicare & Medicaid Services (800) 633-4227 www.cms.gov

National Institute of Biomedical Imaging and Bioengineering (301) 496-8859 www.nibib.nih.gov

National Institute of Mental Health (866) 615-6464 www.nimh.nih.gov

U.S. Department of Health & Human Services (877) 696-6775 www.hhs.gov

National Institute on Aging (800) 222-2225 www.nia.nih.gov

National Institute of Child Health & Human Development (800) 370-2943 www.nichd.nih.gov

National Institute of Nursing Research (301) 496-0207 www.ninr.nih.gov

U.S. National Library of Medicine (301) 496-6308 www.nlm.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (301) 443-2857 www.niaaa.nih.gov

National Institute of Dental and Craniofacial Research (866) 232-4528 www.nidcr.nih.gov

National Institute on Drug Abuse (301) 443-1124 www.drugabuse. gov

18 | PHYSICIANS OFFICE RESOURCE

Why You Should Be Doing Spirometry

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It’s Important - Spirometry is the gold standard for the diagnosis and management of both asthma and COPD. It’s Good Medicine - Your patients are correctly diagnosed and treated more accurately and conveniently in your office. The earlier you detect the disease; the easier you can treat it. It’s Easy - A spirometry test takes less than five minutes to perform. It’s Good Business - Office spirometry is third party reimbursable and will pay for itself within the first year of purchase.

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It’s Safe - The SpiroSafe filter is single use viral/bacterial filters that helps to protect your patients and staff. It is >99% effective against viral and bacterial cross-contamination. Why Micro Direct? - Micro Direct’s spirometry experts will help you choose the right spirometer and then FULLY support your staff from training on how to use the spirometer through billing questions; and all Micro Direct spirometers are backed by a 30-day money back guarantee.

Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240 1-888-287-8556 sales@mdspiro.com

www.mdspiro.com

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DIRECTORIES

S TAT E M E D I C A L A S S O C I AT I O N S

Alabama www.alamedical.org (800) 239-6272

Illinois www.isms.org (800) 782-4767

Missouri www.msma.org (573) 636-5151

Pennsylvania www.pamedsoc.org (855) 726-3348

Alaska www.asmadocs.org (907) 562-0304

Indiana www.ismanet.org (800) 257-4762

Montana www.mmaoffice.org (406) 443-4000

Rhode Island www.rimed.org (401) 331-3207

Arizona www.azmed.org (602) 347-6900

Iowa www.iowamedical. org (515) 223-1401

Nebraska www.nebmed.org (402) 474-4472

South Carolina www.scmedical.org (800) 327-1021

Nevada www.nvdoctors.org (775) 825-6788

South Dakota www.sdsma.org (605) 336-1965

New Hampshire www.nhms.org (800) 564-1909

Tennessee www.tnmed.org (615) 385-2100

New Jersey www.msnj.org (609) 896-1766

Texas www.texmed.org (800) 880-1300

New Mexico www.nmms.org (505) 828-0237

Utah www.utahmed.org (801) 747-3500

New York www.mssny.org (516) 488-6100

Vermont www.vtmd.org (802) 223-7898

North Carolina www.ncmedsoc.org (919) 833-3836

Virginia www.msv.org (800) 746-6768

North Dakota www.ndmed.org (701) 223-9475

Washington www.wsma.org (206) 441-9762

Ohio www.osma.org (800) 766-6762

West Virginia www.wvsma.com (304) 925-0342

Oklahoma www.okmed.org (800) 522-9452

Wisconsin www.wisconsinmedicalsociety.org (866) 442-3800

Arkansas www.arkmed.org (800) 542-1058 California www.cmanet.org (800) 786-4262 Colorado www.cms.org (800) 654-5653 Connecticut www.csms.org (203) 865-0587 District of Columbia www.msdc.org (202) 466-1800 Delaware www.medsocdel.org (302) 366-1400 Florida www.flmedical.org (850) 224-6627 Georgia www.mag.org (678) 303-9290 Hawaii www.hawaiimedicalassociation.org (808) 536-7702 Idaho www.idmed.org (208) 344-7888

20 | PHYSICIANS OFFICE RESOURCE

Kansas www.kmsonline.org (800) 332-0156 Kentucky www.kyma.org (502) 426-6200 Louisiana www.lsms.org (800) 375-9508 Maine www.mainemed.com (207) 622-3374 Maryland www.medchi.org (800) 492-1056 Massachusetts www.massmed.org (781) 893-4610 Michigan www.msms.org (517) 337-1351 Minnesota www.mnmed.org (612) 378-1875 Mississippi www.msmaonline. com (601) 853-6733

Oregon www.theoma.org (503) 619-8000

Wyoming www.wyomed.org (307) 635-2424

Bionet CardioTouch 3000: $1,550.00 Schiller FT-1: $2,530.00 Burdick ELI 280: $4,294.00 Welch Allyn CP150 w/ Interp: $3,645.00

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The Adview 2 is still the only truly modular diagnostic station that grows with your needs. Start with blood pressure and choose temperature or pulse oximetry option at the time of purchase.

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Coaxial Ophth, Fiber Optic Oto, Speucla Dispenser, Aneroid BP, Wall Transformer and Wall Board without Thermometer: $979.00 1019 with Thermometer: $1,416.00

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DIRECTORIES

C O M PA N I E S B Y P R O D U C T C AT E G O R Y

A1C Abbott Rapid Diagnostics www.globalpointofcare. abbott Hemocue America www.Hemocue.com Siemens Healthcare Diagnostics www.siemens-healthineers.com

ABI Huntleigh Diagnostics www.huntleigh-diagnostics.com Medical Device Depot www.medicaldevicedepot.com Newman Medical www.newman-medical. com

ACNE TREATMENT Theravant Corp www.theraclear.com

DermaMed International, Inc. Lipo Sculpting Solutions www.liposculptingsolutions.com Orasure Histofreezer www.histofreezer.com Premier Medical Products www.premusa.com

ALLERGY Jant Pharmacal www.accutest.net

Alma Lasers Cutera, Inc. CryoProbe www.ho-equipments. com 22 | PHYSICIANS OFFICE RESOURCE

Nova Biomedical BLOOD PRESSURE Medical Device Depot www.medicaldevicedepot.com Vitalograph www.vitalograph.com Welch Allyn www.welchallyn.com

Jant Pharmacal www.medicaldevicedepot.com

BONE HEALTH Bone Index Ltd. www.bindex.us

ASTHMA TESTING Micro Direct www.mdspiro.com

BRAIN ASSESMENT Evoke Neuroscience www.evokeneuroscience. com

Vitalograph www.vitalograph.com

AUDIOMETRY Otovation, LLC AESTHETICS Aerolase www.aerolase.com

BLOOD GAS Abbott Point of Care www.globalpointofcare. abbott

Ototronix Diagnostics Augmented Medicine Medpod www.medpodhealth.com

Morningside Medical Equipment www.morningsidemedicalequipment.com

CARDIO VASCULAR/ PULMONARY Abbott Rapid Diagnostics www.globalpointofcare. abbott Brilliant Medical www.brilliantmedical. com

Futuremed America, Inc. www.futuremedamerica. com Medical Device Depot www.medicaldevicedepot.com Micro Direct, Inc. www.mdspiro.com Midmark Diagnostics, Inc. www.midmark.com MIR – Medical International Research www.spirometry.com Nasiff Associates, Inc. www.nasiff.com ndd Medical Technologies www.nddmed.com Nihon Kohden Nonin Medical, Inc. Schiller America, Inc. www.schiller.ch/us SDI Diagnostics, Inc. Vitalograph www.vitalograph.com Welch Allyn www.welchallyn.com

CENTRIFUGES Drucker Diagnostics www.druckerdiagnostics. com

CHEMISTRY ANALYZERS Abbott Diagnostics www.corelaboratory. abbott Abbott Point of Care www.globalpointofcare. abbott AMS Diagnostics www.amsdiagnostics. com Beckman Coulter www.beckmancoulter. com Arkray USA, Inc. Carolina Liquid Chemistries, Inc. www.carolinachemistries. com

Alfa Wassermann, Inc www.alfawassermannus. com Arkray USA, Inc. Beckman Coulter, Inc. www.beckman.com Carolina Liquid Chemistries, Inc. www.carolinachemistries. com Horiba Medical www.horiba.com/us/en/ medical Medica Corporation www.medicacorp.com

DOPPLERS Huntleigh Diagnostics www.huntleigh-diagnostics.com Medical Device Depot www.medicaldevicedepot.com Newman Medical www.newman-medical. com Wallach Surgical Devices www.wallachsurgical. com

ELITech Group www.elitechgroup.com

Polymer Technology Systems

DRUGS OF ABUSE TESTS Carolina Liquid Chemistries www.carolinachemistries. com

Horiba Medical www.horiba.com/us/en/ medical

Randox Laboratories, Inc. www.randox.com

Horiba www.horiba.com/us/en/ medical

Jant Pharmacal www.accutest.net Medica Corporation www.medicacorp.com Randox Laboratories, USA www.randox.com Roche www.roche.com Sekisui www.sekisuidiagnostics. com Vital Diagnostics www.vitaldiagnostics. com

CHOLESTEROL & TRIGLYCERIDE TESTING Abbott Point of Care www.globalpointofcare. abbott Abbott Rapid Diagnostics www.globalpointofcare. abbott

Ortho-Clinical Diagnostics

COAGULATION Roche www.roche.com

CONJUNCTIVITIS TESTS RPS Diagnostics www.rpsdetectors.com

Laboratory Consulting, LLC www.urinedrugscreenconsulting.com Randox Laboratories, Inc. www.randox.com Sekisui www.sekisuidiagnostics. com

CRYOSURGICAL DEVICES CryoProbe www.ho-equipments. com

EAR, NOSE & THROAT Bionix Medical Technologies

CryoConcepts, LP www.cryoconcepts.com

Brilliant Medical www.brilliantmedical. com HEINE North America

DEFIBRILLATORS Cardiac Science www.cardiacscience.com Medical Device Depot www.medicaldevicedepot.com

ECG Edan Diagnostics GE Healthcare Technologies www.gehealthcare.com Medical Device Depot www.medicaldevicedepot.com Midmark Diagnostics, Inc.www.midmark.com Mortara www.mortara.com Schiller America, Inc. www.schilleramerica.com Vitalograph www.vitalograph.com Welch Allyn www.welchallyn.com

EDUCATION AAFP www.aafp.org COLA www.cola.org

ELECTROLYTE Abbott Point of Care www.globalpointofcare. abbott Medica Corporation www.medicacorp.com Opti Medical Systems, Inc. Roche www.roche.com

ENDOSCOPY Panasonic USA

Med-Electronics, Inc. www.med-electronics. com

Pentax Medical

Welch Allyn, Inc. www.welchallyn.com

E-PRESCRIBING Amazing Charts www.amazingcharts.com DrFirst www.drfirst.com

2022 · BUYERS GUIDE | 23

DIRECTORIES

ESR ALCOR Scientific www.alcorscientific.com

EXAM ROOM FURNITURE Brewer Medical www.brewercompany. com Medical Device Depot www.medicaldevicedepot.com Midmark Corporation www.midmark.com Vinyl Crafters www.vcupholstery.com

FECAL OCCULT BLOOD Beckman Coulter, Inc. www.beckmancoulter. com Clinical Genomics www.clinicalgenomics. com Hemosure, Inc. www.hemosure.com Jant Pharmacal www.accutest.net Sekisui www.sekisui.com

GASTROINTESTINAL DISEASE TESTING BioFire www.biofiredx.com

GLUCOSE TESTING Abbott Point of Care www.corelaboratory. abbott Abbott Rapid Diagnostics www.globalpointofcare. abbott

Orchard Software

HEMOGLOBIN ANALYZERS Abbott Rapid Diagnostics www.globalpointofcare. abbott EKF Diagnostics

Jant Pharmacal www.jantdx.com

Masimo Corporation www.masimo.com

Nova Biomedical Roche go.roche.com/rochelancets

IMMUNOASSAY INSTRUMENTS Abbott Diagnostics www.corelaboratory. abbott

H. PYLORI Exalenz www.exalenz.com

BD www.bd.com/veritorsystem

HCV – HIV TESTING Orasure www.orasure.com

BioFire www.BioFireDx.com

ALCOR Scientific www.alcorescientific.com

Cepheid www.cepheid.com

Beckman Coulter, Inc. www.beckmancoulter. com Drucker Diagnostics, Inc. www.qbcdiagnostics. com Hemocue, Inc. www.hemocue.com Horiba Medical www.horiba.com/us/en/ medical

24 | PHYSICIANS OFFICE RESOURCE

Sysmex America, Inc. www.sysmex.com/us

Hemocue, Inc. www.hemocue.com

FLU TESTING BD www.BD.com/veritorsystem

Sekisui www.sekisuidiagnostics. com

Medicus LIS www.medicuslis.com

Hemocue, Inc. www.hemocue.com

HEMATOLOGY ANALYZERS Abbott www.corelaboratory. abbott/hematology

Roche www.Roche.com

Jant Pharmacal www.accutest.net

Beckman Coulter, Inc. www.beckmancoulter. com NanoEnTek www.nanoentek.com Sekisui Diagnostics www.sekisuidiagnostics. com

INFECTIOUS DISEASE BioFire www.BioFireDx.com Roche www.roche.com Sekisui www.sekisui.com

LABORATORY INFORMATION SYSTEMS Alfa Wassermann, Inc Jant Pharmacal www.accutest.net

LABORATORY SANATIZERS Clorox PDI

LAB SERVICES AAFP www.aafp.org COLA www.cola.org COLA Resources Inc. www.criedu.org Laboratory Consulting, LLC www.onlinelabhelp.com Medicus Middleware www.medicusmiddleware.com My Inspection http://.myinspection.us

LANCETS Roche go.roche.com/rochelancets

LEAD TESTING Meridian Bioscience www.magellandx.com

LIPID TESTING Abbott Rapid Diagnostics www.globalpointofcare. abbott METABOLIC TESTING Korr Medical Technologies, Inc. www.korr.com

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Athena Health 2022 · BUYERS GUIDE | 25

For adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea (HU)

EVERY DAY COUNTS. JAKAFI CAN HELP. In a subset of patients, these characteristics may indicate advanced PV despite treatment with HU at the maximum tolerated dose and phlebotomy.1-5 Hct ≥45%

WBC count >11 × 109/L

Disease-related SYMPTOMS

BAT, best available therapy; CHR, complete hematologic remission; Hct, hematocrit; MF, myelofibrosis; WBC, white blood cell.

*The RESPONSE (Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care) trial was a randomized, open-label, active-controlled phase 3 trial comparing Jakafi with BAT in 222 patients with PV. Patients enrolled in the study had been diagnosed with PV for at least 24 weeks, had an inadequate response to or were intolerant of HU, required phlebotomy for Hct control, and exhibited splenomegaly. All patients were required to demonstrate Hct control between 40% and 45% prior to randomization. After week 32, patients were able to cross over to Jakafi treatment.6,7 † The composite primary endpoint was defined as Hct control without phlebotomy eligibility and a ≥35% spleen volume reduction as measured by CT or MRI. To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value).6,7 ‡ BAT included HU (60%), interferon/pegylated interferon (12%), anagrelide (7%), pipobroman (2%), lenalidomide/thalidomide (5%), and observation (15%).6

Indications and Usage Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea. Important Safety Information • Treatment with Jakafi® (ruxolitinib) can cause thrombocytopenia, anemia and neutropenia, which are each dose-related effects. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated • Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary • Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi • Severe neutropenia (ANC <0.5 × 109/L) was generally reversible by withholding Jakafi until recovery • Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines • Tuberculosis (TB) infection has been reported. Observe patients taking Jakafi for signs and symptoms of active TB and manage promptly. Prior to initiating Jakafi, evaluate patients for TB risk factors and test those at higher risk for latent infection. Consult a physician with expertise in the treatment of TB before starting Jakafi in patients with evidence of active or latent TB. Continuation of Jakafi during treatment of active TB should be based on the overall risk-benefit determination

• Progressive multifocal leukoencephalopathy (PML) has occurred with Jakafi treatment. If PML is suspected, stop Jakafi and evaluate • Advise patients about early signs and symptoms of herpes zoster and to seek early treatment • Increases in hepatitis B viral load with or without associated elevations in alanine aminotransferase and aspartate aminotransferase have been reported in patients with chronic hepatitis B virus (HBV) infections. Monitor and treat patients with chronic HBV infection according to clinical guidelines • When discontinuing Jakafi, myeloproliferative neoplasm-related symptoms may return within one week. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotension, DIC, or multi-organ failure. If any of these occur after discontinuation or while tapering Jakafi, evaluate and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi without consulting their physician. When discontinuing or interrupting Jakafi for reasons other than thrombocytopenia or neutropenia, consider gradual tapering rather than abrupt discontinuation • Non-melanoma skin cancers (NMSC) including basal cell, squamous cell, and Merkel cell carcinoma have occurred. Perform periodic skin examinations • Treatment with Jakafi has been associated with increases in total cholesterol, low-density lipoprotein cholesterol, and triglycerides. Assess lipid parameters 8-12 weeks after initiating Jakafi. Monitor and treat according to clinical guidelines for the management of hyperlipidemia • Another JAK-inhibitor has increased the risk of major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, and stroke (compared to those treated with tumor TNF blockers) in patients with

INTERVENE WITH JAKAFI TO ACHIEVE DURABLE COUNT CONTROL In the phase 3 RESPONSE* trial, Jakafi demonstrated superior results† vs BAT‡ Composite Primary Endpoint

23%

(25/110) of patients receiving Jakafi achieved Hct control and ≥35% spleen volume reduction at week 32 vs <1% (1/112) of patients receiving BAT (P < 0.0001)6§

Jakafi 95% CI, 0.15-0.32; BAT 95% CI, 0.00-0.05.6

Individual Component of the Primary Endpoint

60 73% %

(66/110) of patients receiving Jakafi achieved Hct control at week 32 vs 19% (21/112) of patients receiving BAT6 To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value)6,7

Probability of Maintaining Hct Controla at 5 Years in RESPONSE Trial8,9 a

Absence of phlebotomy eligibility

Analysis was conducted in week 32 Hct control responders, beginning at week 328

Kaplan-Meier Estimate: Durability of Hct Control at 5 Years 100

Progression events for the evaluation of duration of absence of phlebotomy eligibility included first of 2 consecutive Hct assessments that confirms phlebotomy eligibility, death, or development of MF or acute leukemia10

Probability, %

80 60 40 20

(95% CI, 0.60-0.83)

+ Censoring times – Jakafi

No. of responders/events/censor: 66/16/50 0

No. at risk Events

108 120 132 144 156 168 180 192 204 216 228 240

Duration of Response, wk

Reprinted from The Lancet Haematology, 7(3), Kiladjian J-J, Zachee P, Hino M, et al, Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study, e226-e237, Copyright 2020, with permission from Elsevier.

252 264

66 66 66 66 66 66 64 63 62 60 58 58 56 56 56 56 56 55 54 54 53 51 49 49 48 48 48 44 44 44 42 42 42 41 40 39 39 39 39 38 28 5 3 1 0 0 0 0 0 0 0 0 1 2 4 5 5 6 6 6 6 6 7 8 8 9 10 10 10 10 10 10 12 12 12 14 14 14 15 15 16 16 16 16 16 16 16 16 16 16

Exploratory Analysis From the RESPONSE Trial11

Mean WBC Counts Over Time¶ Mean WBC Count, × 10 9/L

Secondary Endpoint (26/110) of patients receiving Jakafi achieved the secondary endpoint of CHR at week 32 vs 8% (9/112) of patients receiving BAT (P = 0.0016)6||

20 18 16 14 12 10 8 6 4 2 0

Jakafi BAT

No. of patients

Jakafi 95% CI, 0.16-0.33; BAT 95% CI, 0.04-0.15.

Jakafi BAT

110 111

106 107

Visit, wk 103 105

100 104

96 87

Jakafi reduced mean WBCs as an individual component of CHR. CHR was defined as achieving Hct control (as specified in the primary endpoint), platelet count ≤400 × 109/L, and WBC count ≤109/L.6,7

Intervene with Jakafi in your appropriate patients with advanced PV SWITCHTOJAKAFI.COM rheumatoid arthritis, a condition for which Jakafi is not indicated. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur • Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. In patients with myelofibrosis (MF) and polycythemia vera (PV) treated with Jakafi in clinical trials, the rates of thromboembolic events were similar in Jakafi and control treated patients. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately • Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding NMSC (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi, particularly in patients with a known secondary malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers • In myelofibrosis and polycythemia vera, the most common nonhematologic adverse reactions (incidence ≥15%) were bruising, dizziness, headache, and diarrhea. In acute graft-versus-host disease, the most common nonhematologic adverse reactions (incidence >50%) were infections (pathogen not specified) and edema. In chronic graft-versus-host disease, the most common

nonhematologic adverse reactions (incidence ≥20%) were infections (pathogen not specified) and viral infections • Avoid concomitant use with fluconazole doses greater than 200 mg. Dose modifications may be required when administering Jakafi with fluconazole doses of 200 mg or less, or with strong CYP3A4 inhibitors, or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy • Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus. Women taking Jakafi should not breastfeed during treatment and for 2 weeks after the final dose Please see Brief Summary of Full Prescribing Information for Jakafi on the following pages. To learn more about Jakafi, visit HCP.Jakafi.com References: 1. Barosi G, et al. Br J Haematol. 2010;148(6):961-963. 2. Marchioli R, et al. N Engl J Med. 2013;368(1):22-33. 3. Barbui T, et al. Blood. 2015;126(4):560-561. 4. Emanuel RM, et al. J Clin Oncol. 2012;30(33):4098-4103. 5. Verstovsek S, et al. Cancer. 2014;120(4):513-520. 6. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation. 7. Vannucchi AM, et al. N Engl J Med. 2015;372(5):426-435. 8. Kiladjian J-J, et al. Lancet Haematol. 2020;7(3):e226-e237. 9. Kiladjian J-J, et al. Lancet Haematol. 2020;7(Suppl):1-18. 10. Data on file. Incyte Corporation. Wilmington, DE. 11. Vannucchi AM, et al. N Engl J Med. 2015;372(Suppl):1-25. Jakafi and the Jakafi logo are registered trademarks of Incyte. © 2021, Incyte Corporation. MAT-JAK-02901 10/21

Myelofibrosis The safety ofThe Jakafi safety wasofassessed Jakafi was in 617 assessed in 617 following adverse following events adverse after discontinuing events after discontinuing Jakafi: fever, Jakafi: fever, Myelofibrosis patients in sixpatients clinicalinstudies six clinical with astudies median with duration a median of duration of respiratory distress, respiratory hypotension, distress, hypotension, DIC, or multi-organ DIC, or multi-organ follow-up of 10.9 follow-up months, of 10.9 including months, 301including patients with 301 patients MF in with MF in failure. If onefailure. or moreIf of onethese or more occur of after thesediscontinuation occur after discontinuation Phase 3 two studies. Phase In these 3 studies. two In Phase these3 two studies, Phase 3 studies, of, or while tapering of, or while the dose tapering of Jakafi, the dose evaluate of Jakafi, for and evaluatetwo for and patients a medianhad duration a median of exposure duration to of Jakafi exposure of to Jakafi of treat any intercurrent treat any illness intercurrent and consider illness and restarting consider or restarting or had patients 9.5tomonths (range 9.5 months 0.5 to(range 17 months), 0.5 to with 17 months), 89% with 89% increasing theincreasing dose of Jakafi. the dose Instruct of Jakafi. patients Instruct not to patients not BRIEF SUMMARY: BRIEF For SUMMARY: Full Prescribing For FullInformation, Prescribing Information, of patients treated of patients for more treated thanfor 6 months more than and625% months treated and 25% treated interrupt or discontinue interrupt orJakafi discontinue therapy Jakafi without therapy consulting without consulting see package see insert. package insert. for more thanfor12more months. thanOne 12 months. hundredOne and hundred eleven (111) and eleven (111) their physician. their When physician. discontinuing When discontinuing or interrupting or interrupting INDICATIONSINDICATIONS AND USAGE AND Myelofibrosis USAGE Myelofibrosis Jakafi is Jakafi is patients started patients treatment started at treatment 15 mg twice at 15 daily mgand twice 190daily and 190 therapy with therapy Jakafi for with reasons Jakafiother for reasons than other than indicated for treatment indicated for of intermediate treatment of intermediate or high-risk or high-risk patients started patients at 20started mg twice at 20 daily. mgIntwice patients daily.starting In patients starting thrombocytopenia thrombocytopenia or neutropenia or [see neutropenia Dosage [see and Dosage and myelofibrosismyelofibrosis (MF), including (MF), primary including MF, primary MF, treatment with treatment 15 mg twice with 15 daily mg(pretreatment twice daily (pretreatment platelet platelet Administration (2.7) in Full Prescribing (2.7) in FullInformation], Prescribing Information], post-polycythemia post-polycythemia vera MF and post-essential vera MF and post-essential Administration 9 and ×2010mg /L)twice and 20 daily mg twice daily counts of 100counts to 200of×100 109/L) to 200 consider tapering consider the dose tapering of Jakafi the dose gradually of Jakafi rather gradually than rather than thrombocythemia thrombocythemia MF in adults. MF Polycythemia in adults. Polycythemia Vera Jakafi Vera Jakafi 9 /L),200 × 109/L), (pretreatment(pretreatment platelet counts platelet greater counts than greater 200 × 10 than discontinuing discontinuing abruptly. Non-Melanoma abruptly. Non-Melanoma Skin CancerSkin Cancer is indicated for is treatment indicated for of polycythemia treatment of polycythemia vera (PV) in vera (PV) in 65% and 25% 65% of patients, and 25%respectively, of patients, respectively, required a dose required a dose (NMSC) Non-melanoma (NMSC) Non-melanoma skin cancers skin including cancers basal including cell, basal cell, adults who have adults hadwho an inadequate have had anresponse inadequate to orresponse are to or are reduction the starting belowdose the starting within the dose first within 8 weeks the first 8 weeks squamous cell, squamous and Merkel cell,cell andcarcinoma Merkel cellhave carcinoma occurred have reduction occurred below intolerant of hydroxyurea. intolerant of hydroxyurea. Acute Graft-Versus-Host Acute Graft-Versus-Host therapy. Inofa therapy. double-blind, In a double-blind, randomized, randomized, placebo- placeboin patients treated in patients with Jakafi. treatedPerform with Jakafi. periodic Perform skinperiodic of skin Disease Jakafi Disease is indicated Jakafifor is treatment indicated for of steroidtreatment of steroidcontrolled controlled of Jakafi, study among of Jakafi, the 155 among patients the 155 patients examinations. Lipid Elevations LipidTreatment Elevations with Treatment Jakafi has with Jakafi has study refractory acute refractory graft-versus-host acute graft-versus-host disease (aGVHD) disease in adult (aGVHD) in adult examinations. treated with Jakafi, treatedthe withmost Jakafi, frequent the most adverse frequent reactions adverse reactions been associated been with associated increases with in lipid increases parameters in lipid parameters and pediatricand patients pediatric 12 years patients and 12 older. years Chronic and older. GraftChronic Graftwere thrombocytopenia were thrombocytopenia and anemia [see and Table anemia 2].[see Table 2]. including cholesterol, totallow-density cholesterol,lipoprotein low-density(LDL) lipoprotein (LDL) Versus-HostVersus-Host Disease Jakafi Disease is indicated Jakafifor is treatment indicated for of treatment of totalincluding cholesterol, and cholesterol, triglycerides and triglycerides [see Adverse[see Reactions Adverse (6.1) Reactions (6.1) Thrombocytopenia, Thrombocytopenia, anemia and neutropenia anemia andare neutropenia dose-related are dose-related chronic graft-versus-host chronic graft-versus-host disease (cGVHD) disease after(cGVHD) failure ofafter failure of in Full Prescribing in FullInformation]. Prescribing Information]. The effect of The these effect lipidof these lipidThe three effects. effects. mostThe frequent three most nonhematologic frequent nonhematologic adverse adverse one or two lines oneoforsystemic two linestherapy of systemic in adult therapy and pediatric in adult and pediatric parameter elevations parameter onelevations cardiovascular on cardiovascular morbidity andmorbidityreactions and werereactions bruising,were dizziness bruising, and dizziness headacheand [seeheadache [see patients 12 years patients and 12 older. years and older. mortality hasmortality not beenhas determined not beenindetermined patients treated in patients treated Table 1]. Discontinuation Table 1]. Discontinuation for adverse events, for adverse regardless events, of regardless of CONTRAINDICATIONS CONTRAINDICATIONS None. None. with Jakafi. Assess with Jakafi. lipid parameters Assess lipidapproximately parameters approximately 8-12 8-12 wascausality, causality, observedwas in 11% observed of patients in 11% treated of patients with Jakafi treated with Jakafi WARNINGS AND WARNINGS PRECAUTIONS AND PRECAUTIONS Thrombocytopenia, Thrombocytopenia, weeks following weeks initiation following of Jakafi initiation therapy. of Jakafi Monitor therapy. and Monitor and and 11% of patients and 11% treated of patients with placebo. treated Table with placebo. 1 presents Table 1 presents Anemia andAnemia Neutropenia and Neutropenia Treatment with Treatment Jakafi can with Jakafitreat can according treat to according clinical guidelines to clinicalforguidelines the management for the management the most common the most nonhematologic common nonhematologic adverse reactions adverse reactions cause thrombocytopenia, cause thrombocytopenia, anemia and neutropenia. anemia and neutropenia. [see [see of hyperlipidemia. of hyperlipidemia. Major Adverse Major Cardiovascular Adverse Cardiovascular occurring in patients occurring who in received patients who Jakafireceived in the double-blind, Jakafi in the double-blind, Adverse Reactions Adverse (6.1) Reactions in Full Prescribing (6.1) in FullInformation]. Prescribing Information]. Events (MACE) Events Another (MACE) JAK-inhibitor Another JAK-inhibitor has increasedhas theincreased the placebo-controlled placebo-controlled study during randomized study duringtreatment. randomized treatment. Manage thrombocytopenia Manage thrombocytopenia by reducing the by reducing dose or the doserisk or of MACE,risk including of MACE, cardiovascular including cardiovascular death, myocardial death, myocardial Table 1: Myelofibrosis: Table 1: Myelofibrosis: Nonhematologic Nonhematologic Adverse Adverse temporarily interrupting temporarilyJakafi. interrupting Platelet Jakafi. transfusions Platelet transfusions may may infarction, and infarction, stroke (compared and stroketo(compared those treated to those with treated with Reactions Occurring ReactionsinOccurring Patients on in Jakafi Patients in on Jakafi in be necessarybe[see necessary Dosage [see and Administration Dosage and Administration (2) in Full (2)TNF in Full blockers)TNF in patients blockers)with in patients rheumatoid witharthritis, rheumatoid a arthritis, a the Double-blind, the Double-blind, Placebo-controlled Placebo-controlled Study Study Prescribing Information]. Prescribing Information]. Patients developing Patientsanemia developing may anemia may for condition condition which Jakafi for which is not indicated. Jakafi is not Consider indicated. the Consider the During Randomized During Randomized Treatment Treatment require bloodrequire transfusions blood transfusions and/or dose modifications and/or dose modifications of of and benefits benefits risks for and the individual risks for the patient individual prior patient to prior to 9 Jakafi Jakafi Placebo Placebo /L) 0.5 × initiating Jakafi. SevereJakafi. neutropenia Severe (ANC neutropenia less than (ANC 0.5less × 10than 109/L) or continuing initiating ortherapy continuing with therapy Jakafi particularly with Jakafiinparticularly in (N=155) (N=155)(N=151) (N=151) was generallywas reversible generally byreversible withholding byJakafi withholding until Jakafi until patients whopatients are current whoorare past current smokers or past andsmokers patients and patients All Grade Grade All Grade All Grade Grade Grade All Grade Grade recovery. Perform recovery. a pre-treatment Perform a pre-treatment complete blood complete count blood count with other cardiovascular with other cardiovascular risk factors. Patients risk factors. should Patients be should be Gradesa 3 Grades 4 aGrades 3 43 Grades 4 3 4 Adverse Adverse (CBC) and monitor (CBC) CBCs and monitor every 2CBCs to 4 weeks every 2until to 4doses weeks untilinformed doses about informed the symptoms about theofsymptoms serious cardiovascular of serious cardiovascular (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) Reactions Reactions are stabilized,are and stabilized, then as clinically and thenindicated as clinically [seeindicated [see events and the events stepsand to take the steps if theytooccur. take ifThrombosis they occur. Thrombosis b Bruising Bruisingb23 < 1 23 0 <151 00 15 0 0 0 Dosage and Administration Dosage and Administration (2) in Full Prescribing (2) in Full PrescribingAnother JAK-inhibitor Another JAK-inhibitor has increasedhas theincreased risk of the risk of c c < 1 18 0 <71 00 70 0 0 Dizziness Dizziness18 Information].Information]. Risk of Infection Risk of Serious Infection bacterial, Serious bacterial,thrombosis, including thrombosis, deep including venous deep thrombosis venous(DVT), thrombosis (DVT), mycobacterial, mycobacterial, fungal and viral fungal infections and viral have infections occurred have occurred 15 0 15 0 05 00 50 0 0 pulmonary embolism pulmonary (PE), embolism and arterial (PE),thrombosis and arterial thrombosisHeadache Headache [see Adverse[see Reactions Adverse (6.1) Reactions in Full Prescribing (6.1) in Full Prescribing (compared to(compared Tract Urinary Tract those treated to those with TNF treated blockers) with TNF in patients blockers) inUrinary patients 9d 0 90 05 <0 1 <51 < 1 < 1 d Infections Information].Information]. Delay startingDelay therapy starting with therapy Jakafi until with Jakafi until with rheumatoid witharthritis, rheumatoid a condition arthritis,for a condition which Jakafi for which is Jakafi is e Infections e Weight Gain Weight Gain 7 < 1 7 0 < 1 1 <0 1 10 <1 0 active seriousactive infections serious have infections resolved. have Observe resolved. patients Observe not patients indicated.not In indicated. patients with In patients MF and with PV treated MF andwith PV treated with receiving Jakafi receiving for signs Jakafi andfor symptoms signs andofsymptoms infection and of infection and Flatulence Flatulence5 0 50 <0 1 00 <01 0 0 Jakafi in clinical Jakafi trials, in clinical the rates trials, of thromboembolic the rates of thromboembolic manage promptly. manage Usepromptly. active surveillance Use active and surveillance and events were events ZosterfHerpes Zoster 2 f 0 20 <0 1 00 <01 0 0 similar were in Jakafi similar andincontrol Jakafitreated and control patients. treated Herpes patients. prophylactic prophylactic antibiotics according antibiotics to according clinical guidelines. to clinical guidelines. Patients withPatients symptoms withofsymptoms thrombosisofshould thrombosis be should bea National CanceraInstitute NationalCommon Cancer Institute Terminology Common Criteria Terminology for Adverse Criteria Events for Adverse Events Tuberculosis Tuberculosis Tuberculosis infection hasinfection been reported has been in reported in evaluated (CTCAE), version 3.0 (CTCAE), version 3.0 promptly promptly andevaluated treated appropriately. and treated appropriately. Secondary Secondary b b includes contusion, includes ecchymosis, contusion, hematoma, ecchymosis, injection hematoma, site hematoma, injection site hematoma, patients receiving patients Jakafi. receiving Observe Jakafi. patients Observe receiving patients receiving Malignancies Malignancies Another JAK-inhibitor Another JAK-inhibitor has increasedhas theincreased the hematoma, periorbital periorbital vesselhematoma, puncture site vessel hematoma, punctureincreased site hematoma, tendency increased tendency Jakafi for signs Jakafi andfor symptoms signs andofsymptoms active tuberculosis of active and tuberculosis risk ofand lymphoma risk ofand lymphoma other malignancies and other malignancies excluding excluding to bruise, petechiae, to bruise, purpura petechiae, purpura manage promptly. manage Prior promptly. to initiating PriorJakafi, to initiating patients Jakafi, patients c c NMSC (compared NMSCto(compared those treated to those with TNF treated blockers) with TNF in blockers) in dizziness,includes includes posturaldizziness, dizziness, postural vertigo,dizziness, balance disorder, vertigo, balance Meniere’s disorder, Meniere’s should be evaluated should be forevaluated tuberculosis for risk tuberculosis factors, and risk factors,patients and withpatients Disease, labyrinthitis rheumatoid witharthritis, rheumatoid a condition arthritis,for a condition which ford Disease, which labyrinthitis d includes urinary tract includes infection, urinary cystitis, tract infection, urosepsis, cystitis, urinary urosepsis, tract infection urinary tract infection those at higher those riskatshould higherberisk tested should for be latent tested infection. for latent infection. Jakafi is not indicated. Jakafi is not Patients indicated. whoPatients are current whoorare past current orbacterial, past kidney infection, bacterial, pyuria, kidney infection, bacteria urine, pyuria, bacteria bacteria urine urine, identified, bacteria urine identified, Risk factors include, Risk factors but are include, not limited but areto,not prior limited residence to, prior residence smokers are smokers at additional are at increased additional risk. increased Considerrisk. the Considernitrite theurine present nitrite urine present in or travel toincountries or travel with to countries a high prevalence with a highofprevalence ofbenefits and benefits risks for and the individual risks for the patient individual prior patient to prior etoincludes weighteincreased, includes weight abnormal increased, weight abnormal gain weight gain f f tuberculosis,tuberculosis, close contactclose with contact a personwith witha active person with active includes herpes zoster includes andherpes post-herpetic zoster and neuralgia post-herpetic neuralgia initiating or continuing initiating ortherapy continuing with therapy Jakafi, particularly with Jakafi,inparticularly in tuberculosis,tuberculosis, and a historyand of active a history or latent of active tuberculosis or latent tuberculosis Description Description of Selected of Adverse Selected Reactions: AdverseAnemia Reactions: Anemia patients withpatients a knownwith secondary a knownmalignancy secondary(other malignancy than (other than where an adequate where an course adequate of treatment course of cannot treatment be cannot be In thea two Phase In the3 two clinical Phase studies, 3 clinical median studies, time median to time to a successfullya successfully treated NMSC), treated patients NMSC), whopatients develop who a develop confirmed. For confirmed. patients with For patients evidencewith of active evidence or latent of active ormalignancy, latent CTCAEofGrade first CTCAE 2 or higher Gradeanemia 2 or higher was anemia was and malignancy, patients and whopatients are current whoorare past current or pastonset of first onset tuberculosis,tuberculosis, consult a physician consultwith a physician expertisewith in the expertise in the approximatelyapproximately 6 weeks. One6 patient weeks.(< One 1%) patient discontinued (< 1%) discontinued smokers. ADVERSE smokers. REACTIONS ADVERSE REACTIONS The followingThe clinically following clinically treatment of treatment tuberculosis of before tuberculosis starting before Jakafi. starting The Jakafi. The treatment because treatment of anemia. becauseInofpatients anemia.receiving In patients Jakafi, receiving Jakafi significant adverse significant reactions adverse arereactions discussedare in discussed greater in greater decision to continue decisionJakafi to continue duringJakafi treatment during of treatment active of active mean decreases meanin decreases hemoglobinin reached hemoglobin a nadir reached of a nadir of detail in otherdetail sections in other of the sections labeling: of •the Thrombocytopenia, labeling: • Thrombocytopenia, tuberculosis should tuberculosis be based should on be thebased overallonrisk-benefit the overall risk-benefit approximatelyapproximately 1.5 to 2.0 g/dL 1.5below to 2.0baseline g/dL below afterbaseline 8 to 12 after 8 to 12 Anemia and Neutropenia Anemia and [see Neutropenia Warnings[see andWarnings Precautions and Precautions determination. determination. Progressive Multifocal Progressive Multifocal weeks of therapy weeks and of then therapy gradually and then recovered gradually to recovered reach a to reach a (5.1) in Full Prescribing (5.1) in FullInformation] Prescribing •Information] Risk of Infection • Risk of Infection Leukoencephalopathy Leukoencephalopathy Progressive multifocal Progressive multifocal [see Warnings[see new steady state new steady that was state approximately that was approximately 1.0 g/dL below 1.0 g/dL below andWarnings Precautions and(5.2) Precautions in Full Prescribing (5.2) in Full Prescribing leukoencephalopathy leukoencephalopathy (PML) has occurred (PML) has withoccurred Jakafi with Jakafi pattern was Thisobserved pattern was in patients observed regardless in patients regardless Information] •Information] Symptom Exacerbation • Symptom Exacerbation Following Followingbaseline. Thisbaseline. treatment. If treatment. PML is suspected, If PML isstop suspected, Jakafi and stopevaluate. Jakafi and evaluate. of whether they of whether had received they had transfusions received transfusions during therapy. during therapy Interruption orInterruption Discontinuation or Discontinuation of Treatment of with Treatment Jakafi with Jakafi Herpes ZosterHerpes AdviseZoster patients Advise about patients early signs aboutand early signs and In the randomized, In the randomized, placebo-controlled placebo-controlled study, 60% ofstudy, 60% of [see Warnings[see andWarnings Precautions and(5.3) Precautions in Full Prescribing (5.3) in Full Prescribing symptoms ofsymptoms herpes zoster of herpes and tozoster seek treatment and to seek as treatment as patients treated patients with Jakafi treatedand with38% Jakafi of patients and 38%receiving of patients receiving Information ] Information • Non-Melanoma ] • Non-Melanoma Skin Cancer [see SkinWarnings Cancer [see Warnings early as possible earlyifas suspected. possible ifHepatitis suspected. B Hepatitis HepatitisBBviral Hepatitis viral and (5.4) placebo received placebo red received blood cellred transfusions blood cell transfusions during during andBPrecautions Precautions in Full Prescribing (5.4) in FullInformation] Prescribing Information] load (HBV-DNA load titer) (HBV-DNA increases, titer) with increases, or without with associated or without associated treatment. randomizedAmong treatment. transfused Amongpatients, transfused the patients, the • Lipid Elevations • Lipid [see Elevations Warnings[see andWarnings Precautions and (5.5) Precautionsrandomized (5.5) elevations in elevations alanine aminotransferase in alanine aminotransferase and aspartateand aspartate median of units number transfused of unitsper transfused month was per1.2 month was 1.2 in Full Prescribing in FullInformation] Prescribing •Information] Major Adverse • Major Adverse median number aminotransferase, aminotransferase, have been reported have been in patients reportedwith in patientsCardiovascular with in patients treated in patients with Jakafi treatedand with1.7 Jakafi in placebo and 1.7treated in placebo treated Cardiovascular Events (MACE)Events [see Warnings (MACE) [see andWarnings Precautions and Precautions chronic HBV infections chronic HBV taking infections Jakafi.taking The effect Jakafi. of The Jakafi effect of Jakafi patients. Thrombocytopenia patients. Thrombocytopenia In the two Phase In the3 two clinical Phase 3 clinical (5.6) in Full Prescribing (5.6) in FullInformation] Prescribing•Information] Thrombosis•[see Thrombosis [see on viral replication on viralinreplication patients with in patients chronic with HBV infection chronic HBV infection studies,who in patients developed whoGrade developed 3 or 4 Grade 3 or 4 Warnings andWarnings Precautions and(5.7) Precautions in Full Prescribing (5.7) in Full Prescribingstudies, in patients is unknown. Patients is unknown. withPatients chronic with HBV infection chronic HBV should infection Information] should thrombocytopenia, the median time the median to onsettime wasto onset was •Information] Secondary •Malignancies Secondary Malignancies [see Warnings[see andWarnings and thrombocytopenia, be treated and bemonitored treated and according monitored to according clinical guidelines. to clinical guidelines. approximatelyapproximately 8 weeks. Thrombocytopenia 8 weeks. Thrombocytopenia was generallywas generally Precautions (5.8) Precautions in Full Prescribing (5.8) in FullInformation]. Prescribing Information]. Clinical Clinical Symptom Exacerbation Symptom Exacerbation Following Interruption Following Interruption or or Experience reversible with reversible dose reduction with dose or dose reduction interruption. or dose interruption. Trials Trials Because Experience clinical Because trials clinical are conducted trials are conducted Discontinuation Discontinuation of Treatmentofwith Treatment Jakafi Following with Jakafi Following The median time The median to recovery timeoftoplatelet recovery counts of platelet abovecounts above under widelyunder varying widely conditions, varyingadverse conditions, reaction adverse ratesreaction rates 9 discontinuation discontinuation of Jakafi, symptoms of Jakafi,from symptoms from 1410 days. /L was Platelet 14 days. transfusions Platelet transfusions were were × 109/L was 50 × observed in the observed clinicalintrials the clinical of a drug trials cannot of a be drug directly cannot be50directly myeloproliferative myeloproliferative neoplasms may neoplasms return tomay pretreatment return to pretreatment administered to 5% of patients to 5%receiving of patients Jakafi receiving and to 4% Jakafi and to 4% compared to compared rates in thetoclinical rates intrials the clinical of another trialsdrug of anotheradministered drug levels over a levels periodover of approximately a period of approximately one week. Some one week. and Some of patients receiving of patients control receiving regimens. control Discontinuation regimens. Discontinuation may not and reflect may thenot rates reflect observed the rates in practice. observed in practice. patients withpatients MF havewith experienced MF have experienced one or more of onethe or more of the

of treatment because of treatment of thrombocytopenia because of thrombocytopenia occurred in occurred in 4: Polycythemia Table 4: Polycythemia Vera: Selected Laboratory Table Vera: Selected Laboratory drugs [see Clinical drugs Studies [see Clinical (14.4)Studies in full Prescribing (14.4) in full Prescribing < 1% of patients < 1%receiving of patients Jakafi receiving and < 1% Jakafi of patients and < 1% of patients Abnormalities Abnormalities in the Open-Label, Activein the Open-Label, ActiveInformation];Information]; sixty-five patients sixty-five crossed patients overcrossed from best over from best nreceiving control receiving regimens. control Patients regimens. with Patients a plateletwith count a platelet count controlled Study controlled up to Study Week 32 up of to Week 32 of available therapy available to treatment therapy to with treatment Jakafi, for with a total Jakafi, of for a total of 9 9 9 9 a a 200 /L /L to before 200 × starting 10 /L before Jakafistarting had Jakafi had RandomizedRandomized of 100 × 10 /L of to 100 ×× 1010 Treatment Treatment 230 patients 230 treated patients with Jakafi. treatedThe withmedian Jakafi.duration The median of duration of a higher frequency a higher of frequency Grade 3 orof4 Grade thrombocytopenia 3 or 4 thrombocytopenia exposure to Jakafi exposure for the to Jakafi study was for the 49.7 study weeks was(range, 49.7 weeks 0.7 (range, 0.7 Jakafi Jakafi Best AvailableBest Available compared to compared patients with to patients a platelet with count a platelet greatercount than greater than 144.9 weeks) to 144.9 in theweeks) Jakafi arm. in theOne Jakafi hundred arm. One and nine hundred and nine (N=110) (N=110) Therapy (N=111) Therapyto(N=111) (17%×versus 7%). Neutropenia versus 7%). Neutropenia In the two In the two 109/L (17% d 200 × 109/L 200 (47%) patients(47%) werepatients on Jakafiwere for at onleast Jakafi 1 year. for atThere least were 1 year. There were All Grade Grade All Grade All Grade Grade Grade All Grade Grade Phase 3 clinical Phase studies, 3 clinical 1% ofstudies, patients 1%reduced of patients or stopped reduced orLaboratory stopped Laboratory five five reactions fatal adverse to Jakafi, reactions including to Jakafi, 1 from including toxic 1 from toxic Gradesb 3 Grades 4 b Grades 3 43 Grades 4 3 fatal 4 adverse Parameter Parameter Jakafi because Jakafi of neutropenia. because of Table neutropenia. 2 provides Table the2 provides the epidermal epidermal andnecrolysis 4 from neutropenia, and 4 from anemia neutropenia, and/oranemia and/or (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) necrolysis frequency andfrequency severity of and clinical severity hematology of clinicalabnormalities hematology abnormalities thrombocytopenia. thrombocytopenia. An adverse reaction An adverse resulting reaction in treatment resulting in treatment Hematology Hematology reported for patients reportedreceiving for patients treatment receiving with treatment Jakafi orwith Jakafi or discontinuation discontinuation occurred in 18% occurred of patients in 18% treated of patients with treated with Anemia Anemia 72 < 1 <721 <581 <01 58 0 0 0 placebo in theplacebo placebo-controlled in the placebo-controlled study. study. Jakafi. Jakafi.reaction An adverse resulting reaction in dose resulting modification in dose modification Thrombocytopenia Thrombocytopenia 27 5 <271 24 5 <31 <241 3 <An 1 adverse occurred and an in adverse 27%, andreaction an adverse resulting reaction in resulting in Table 2: Myelofibrosis: Table 2: Myelofibrosis: Worst Hematology Worst Hematology Laboratory Laboratory Neutropenia Neutropenia 3 0 <31 10 0 << 11 10 0 <occurred 1 0 in 27%, treatment interruption treatmentoccurred interruption in 23%. occurred The most in 23%. common The most common Abnormalities Abnormalities in the Placebo-Controlled in the Placebo-Controlled Studya Chemistry Studya Chemistry s hematologic adverse hematologic reactions adverse (incidence reactions > 35%) (incidence are > 35%) are Jakafi Jakafi Placebo Placebo Hypercholesterolemia Hypercholesterolemia 35 0 35 0 80 00 08 0 0 and thrombocytopenia. anemia anemia and thrombocytopenia. The most common The most common (N=155) (N=155)(N=151) (N=151) Elevated ALT Elevated ALT 25 < 1 25 0 <161 00 16 0 0 0 nonhematologic nonhematologic adverse reactions adverse (incidence reactions ≥ 20%) (incidence are ≥ 20%) are All Grade Grade All Grade All Grade Grade All Grade GradeAST Elevated AST Elevated 23 0 23 0 23 0 <0 1 23 0 <infections 1 0 (pathogen infections not (pathogen specified) not and specified) viral infection. and viral Table infection. 7 Table 7 b b Laboratory Laboratory Grades 3 Grades 4 Grades 3 43 Grades 4 3 4 presents presents frequent the most nonlaboratory frequent nonlaboratory adverse reactions adverse reactions Hypertriglyceridemia Hypertriglyceridemia 15 0 15 0 13 0 00 13 0 0 0 the most Parameter Parameter (%) (%) (%) (%) (%) (%) (%) (%) (%) a a d occurring Cycle 7 up Dayto1Cycle of randomized 7 Day 1 oftreatment. randomized treatment. are worst values Grade values are worst regardless Grade values of baseline regardless of baselineoccurring up to Thrombocytopenia Thrombocytopenia 70 9 704 31 9 41 31 0 1b Presented 0 valuesPresented National CancerbInstitute NationalCommon Cancer Institute Terminology Common Criteria Terminology for Adverse Criteria Events, for Adverse Events, Table 7: Chronic Table Graft-Versus-Host 7: Chronic Graft-Versus-Host Disease: All-Grade Disease: All-Grade Anemia Anemia 96 34 96 11 87 34 11 16 87 3 16version33.0 version 3.0 (≥ 10%) and (≥ Grades 10%)3-5 and(≥Grades 3%) Nonlaboratory 3-5 (≥ 3%) Nonlaboratory Neutropenia Neutropenia 19 5 192 45 <21 14 <Acute 1 1Graft-Versus-Host Acute Graft-Versus-Host Disease In a single-arm, Disease In a single-arm, Adverse Reactions Adverse Occurring Reactions in Occurring Patients ininthe Patients in the a a values Presented are worst values Grade values are worst regardless Grade values of baseline regardless of baseline open-label study, open-label 71 adults study, (ages 71 18-73 adults years) (ages 18-73 were years) were fib Presented Open-Label, Open-Label, Active-controlled Active-controlled Study up to Cycle Study up to Cycle National Cancerb Institute NationalCommon Cancer Institute Terminology Common Criteria Terminology for Adverse Criteria Events, for Adverse Events, treated with Jakafi treatedforwith aGVHD Jakafi failing for aGVHD treatment failing with treatment with version 3.0 version 3.0 7 Day 1 of Randomized 7 Day 1 of Randomized Treatment Treatment steroids or without with other or without immunosuppressive other immunosuppressive drugs drugs Additional Data Additional from the Data Placebo-Controlled from the Placebo-Controlled Study Study with steroids Jakafi Jakafi Best AvailableBest Available [see Clinical Studies [see Clinical (14.3) Studies in Full Prescribing (14.3) in Full Information]. Prescribing Information]. • 25% of patients • 25%treated of patients with Jakafi treatedand with7% Jakafi of patients and 7% of patients (N = 165) (N Therapy = 165)(N = Therapy 158) (N = 158) The median of treatment duration with of treatment Jakafi was with46Jakafi days was 46 days treated with placebo treated with developed placebonewly developed occurring newly or occurring The or median duration All Grade All All Grade Grade All Grade (range, 4-382 (range, days). 4-382 There were days). no There fatal were adverse no fatal reactions adverse reactions worsening Grade worsening 1 abnormalities Grade 1 abnormalities in alanine transaminase in alanine transaminase a Gradesa ≥ 3Grades Grades ≥ 3 ≥ Grades 3 ≥3 to Jakafi. to Jakafi.reaction An adverse resulting reaction in treatment resulting in treatment (ALT). The incidence (ALT). The of greater incidence than of greater or equalthan to Grade or equal 2 to Grade 2 An adverse b b (%) (%) (%) (%) (%) (%) (%) (%) Adverse Reactions Adverse Reactions discontinuation discontinuation occurred in 31% occurred of patients. in 31%The of patients. most The most elevations was elevations 2% for Jakafi was 2% with for1% Jakafi Grade with 3 and 1% Grade no 3 and no common common reaction adverse leading reaction to treatment leading to treatment Infections andInfections infestations and infestations Grade 4 ALT elevations. Grade 4 ALT• elevations. 17% of patients • 17%treated of patients with treated with adverse discontinuation discontinuation was infectionwas (10%). infection Table 5(10%). showsTable the 5 showsInfections the (pathogen Infections (pathogen Jakafi and 6% Jakafi of patients and 6%treated of patients with placebo treated with developed placebo developed 15 45 44 15 16 44 16 adverse adverse other reactions than laboratory other than abnormalities. laboratory abnormalities. not specified) not specified)45 newly occurring newly or worsening occurring orGrade worsening 1 abnormalities Grade 1 abnormalities in in reactions Viral infections Viral infections 28 5 28 23 5 5 23 5 Table 5: Acute Table Graft-Versus-Host 5: Acute Graft-Versus-Host Disease: Disease: aspartate transaminase (AST). The incidence (AST). The of Grade incidence 2 of Grade 2 easpartate transaminase Musculoskeletal Musculoskeletal and connective andtissue connective disorders tissue disorders Nonhematologic Adverse Reactions AdverseOccurring Reactions Occurring AST elevations AST was elevations < 1% forwas Jakafi < 1% with fornoJakafi Gradewith 3 orno4 Grade 3 or 4Nonhematologic Musculoskeletal Musculoskeletal pain 18 pain 1 18 13 1 0 13 0 in ≥ 15%inofthe Patients Open-Label, in the Open-Label, SingleSingleAST elevations. AST• elevations. 17% of patients • 17%treated of patients with Jakafi treatedand with Jakafi andin ≥ 15% of Patients General disorders General anddisorders administration and administration site conditionssite conditions < 1% of patients < 1%treated of patients with placebo treated with developed placebonewly developed newly Cohort StudyCohort Study Pyrexia Pyrexia 16 2 16 9 2 1 9 1 occurring or worsening occurring orGrade worsening 1 elevations Grade in 1 elevations cholesterol.in cholesterol. Jakafi (N=71)Jakafi (N=71) Fatigue Fatigue 13 1 13 10 1 2 10 2 The incidenceThe of Grade incidence 2 cholesterol of Grade 2elevations cholesterol was elevations was a a b b Adverse Reactions Adverse Reactions All Grades (%) All Grades Grade 3-4 (%)(%)Grade 3-4 (%) Edema Edema 10 1 10 12 1 1 12 1 < 1% for Jakafi < 1% with fornoJakafi Gradewith 3 orno4 Grade cholesterol 3 or 4 cholesterol Infections (pathogen 55 Vascular disorders Vascular disorders elevations. Polycythemia elevations. Polycythemia Vera In a randomized, Vera In a randomized, Infections (pathogen 55 41 41 not specified) not specified) Hypertension Hypertension16 5 16 13 5 7 13 7 open-label, active-controlled open-label, active-controlled study, 110 patients study, 110 withpatients PV with PV Edema Edema 51 51 13 13Hemorrhage Hemorrhage 12 2 12 15 2 2 15 2 resistant to orresistant intolerant to of or hydroxyurea intolerant of hydroxyurea received Jakafi received Jakafi Hemorrhage Hemorrhage 49 49 20 20 Respiratory, thoracic Respiratory, and mediastinal thoracic and disorders mediastinal disorders and 111 patients and 111 received patients bestreceived availablebest therapy available [see therapy Fatigue [see Fatigue 37 37 14 14Cough Cough 13 0 13 8 0 0 8 0 Clinical Studies Clinical (14.2)Studies in Full (14.2) Prescribing in FullInformation]. Prescribing Information]. Bacterial infections Bacterial infections 32 32 28 28Dyspnea Dyspnea 11 1 11 8 1 1 8 1 The most frequent The most adverse frequent reaction adverse wasreaction anemia.was anemia. Dyspnea Dyspnea 32 32 7 7 Gastrointestinal Gastrointestinal disorders disorders Discontinuation Discontinuation for adverse events, for adverse regardless events,ofregardless of Viral infectionsViral infections 31 31 14 14Nausea Nausea 12 0 12 13 0 2 13 2 causality, observedwas in 4% observed of patients in 4%treated of patients with treatedThrombosis with y causality, was Thrombosis 25 25 11 11Diarrhea Diarrhea 10 1 10 13 1 1 13 1 Jakafi. Table 3Jakafi. presents Tablethe3 most presents frequent the most nonhematologic frequent nonhematologic a 7 Diarrhea Diarrhea 24 24 7 National CanceraInstitute NationalCommon Cancer Institute Terminology Common Criteria Terminology for Adverse Criteria Events for Adverse Events adverse reactions adverse occurring reactions up occurring to Week 32. up to Week 32. (CTCAE), version (CTCAE), 4.03 version 4.03 Rash Rash 23 23 3 3 b b Grouped terms that Grouped are composites terms thatofare applicable composites adverse of applicable reaction adverse terms. reaction terms. Table 3: Polycythemia Table 3: Polycythemia Vera: Nonhematologic Vera: Nonhematologic Adverse Adverse 21 4 4 Headache Headache 21 Reactions Occurring ReactionsinOccurring ≥ 5% of Patients in ≥ 5%on of PatientsHypertension on Clinically relevant Clinically laboratory relevant abnormalities laboratory abnormalities are shown inare shown in Hypertension 20 13 13 20 Jakafi in theJakafi Open-Label, in the Open-Label, Active-controlled Active-controlled Dizziness 16 0 0 8. Dizziness 16 Table Table 8. a a Study up to Week Study 32 upof toRandomized Week 32 of Randomized Treatment Treatment Selected laboratory Selected abnormalities laboratory areabnormalities listed in Tableare 6 below listed in Table 6 below Table 8: Chronic TableGraft-Versus-Host 8: Chronic Graft-Versus-Host Disease: Selected Disease: Selected b National Cancer bInstitute NationalCommon Cancer Institute Terminology Common Criteria Terminology for Adverse Criteria Eventsfor Adverse Events Laboratory Abnormalities Laboratory Abnormalities in the Open-Label, in the Open-Label, Jakafi Jakafi Best AvailableBest Available (CTCAE), version 4.03 (CTCAE), version 4.03 (N=110) (N=110) Therapy (N=111) Therapy (N=111) Active-controlled Active-controlled Study up to Study Cycle 7upDay to Cycle 1 7 Day 1 Selected laboratory Selected abnormalities laboratory abnormalities during treatment during with treatment with of Randomized of Randomized Treatmenta Treatmenta GradeAll AllGradeGradeAll Grade All Jakafiinare Table shown 6. in Table 6. a d Grades 3-4 3-4Grades Jakafi 3-4are shown Gradesa 3-4Grades Jakafi Jakafi Best AvailableBest Available Adverse Reactions Table Graft-Versus-Host 6: Acute Graft-Versus-Host Disease: Selected Disease: Selected (%) (%) (%) (%) (%) (%) (%) Table (%)6: Acute fi,Adverse Reactions (N=165) (N=165) Therapy (N=158) Therapy (N=158) Laboratory Abnormalities Worsening from Worsening from Diarrhea Diarrhea 15 0 15 7 0 < 1 7 < 1 Laboratory Abnormalities All Grade All All GradeGradeAll Grade b b Baseline Open-Label, in the Open-Label, Single CohortSingle StudyCohort Study Dizziness Dizziness 15 0 15 13 0 0 13 0 Baseline in the b Gradesb ≥ 3Grades Grades ≥ 3 ≥ 3Grades ≥3 Dyspneac 13 3 13 4 3 0 4 0 a Dyspneac Laboratory Test Jakafi (N=71)Jakafi (N=71) Laboratory Test (%) (%) (%) (%) (%) (%) (%) (%) Muscle SpasmsMuscle Spasms 12 < 1 12 5 < 1 0 5 0 Hematology Hematology Worst grade during Worst grade treatment during treatment Constipation Constipation 8 0 8 3 0 0 3 0 a a Anemia Anemia 82 13 82 75 13 8 75 8 (%) Grade 3-4 (%) (%) Grade 3-4 (%) All Grades All Grades Laboratory Parameter Laboratory Parameter d d <1 6 0 <1 0 0 0 y. Herpes Zoster Herpes Zoster 6 Thrombocytopenia Thrombocytopenia 27 12 27 23 12 9 23 9 Hematology Hematology Nausea Nausea 6 0 6 4 0 0 4 0 Neutropenia Neutropenia 58 20 58 54 20 17 54 17 Anemia 75 75 45 45 0 6 < 1 0 0 < 1 Anemia 0 gWeight Gaine Weight Gaine 6 Chemistry Chemistry f f Thrombocytopenia 75 75 61 61 Urinary Tract Infections Urinary Tract Infections 6 0 6 3 0 0 3 Thrombocytopenia 0 Hypercholesterolemia Hypercholesterolemia 88 10 88 85 10 8 85 8 Neutropenia 58 58 40 40 Hypertension Hypertension 5 < 1 5 3 < 1 < 1 3 Neutropenia <1 Elevated AST Elevated AST 65 5 65 54 5 6 54 6 a a Chemistry Chemistry National Cancer Institute NationalCommon Cancer Institute Terminology Common Criteria Terminology for Adverse Criteria Events for Adverse Events Elevated ALT Elevated ALT 73 11 73 71 11 16 71 16 (CTCAE), version (CTCAE), 3.0 version 3.0 Elevated ALT Elevated ALT 48 48 8 8 b b includes dizziness includes and vertigo dizziness and vertigo Gamma Gamma Elevated AST Elevated AST 48 48 6 6 c c includes dyspnea includes and dyspnea dyspnea exertional and dyspnea exertional glutamyltransferase glutamyltransferase 81 42 81 75 42 38 75 38 d d Hypertriglyceridemia Hypertriglyceridemia 11 11 1 1 includes herpes zoster includes andherpes post-herpetic zoster and neuralgia post-herpetic neuralgia increased increased e a includes weighteincreased includes weight and abnormal increased weight and abnormal gain weight gain National Cancera Institute NationalCommon Cancer Institute Terminology Common Criteria Terminology for Adverse Criteria Events, for Adverse Events, Creatinine increased Creatinine increased 47 1 47 40 1 2 40 2 f f includes infection urinary andtract cystitis infection and cystitis version 4.03 version 4.03 y includes urinary tract Elevated lipaseElevated lipase38 12 38 30 12 9 30 9 Clinically relevant Clinically laboratory relevant abnormalities laboratory abnormalities are shown are shown Chronic Graft-Versus-Host Chronic Graft-Versus-Host Disease In a Phase Disease3,In a Phase 3, Elevated amylase Elevated amylase 35 8 35 25 8 4 25 4 in Table 4. in Table 4. randomized, open-label, randomized,multi-center open-label, study, multi-center 165 patients study, 165 patients a a Presented values Presented are worst values Grade values are worst regardless Grade values of baseline regardless of baseline were treated were with Jakafi treatedand with158 Jakafi patients and 158 werepatients treated were treated b b National Cancer Institute NationalCommon Cancer Institute Terminology Common Criteria Terminology for Adverse Criteria Events, for Adverse Events, with best available with best therapy available for cGVHD therapy failing for cGVHD treatment failing treatment % version 4.03 version 4.03 with steroids with with steroids or without with other or without immunosuppressive other immunosuppressive

DRUG INTERACTIONS Fluconazole Concomitant use of Jakafi with fluconazole increases ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information], which may increase the risk of exposurerelated adverse reactions. Avoid concomitant use of Jakafi with fluconazole doses of greater than 200 mg daily. Reduce the Jakafi dosage when used concomitantly with fluconazole doses of less than or equal to 200 mg [see Dosage and Administration (2.5) in Full Prescribing Information]. Strong CYP3A4 Inhibitors Concomitant use of Jakafi with strong CYP3A4 inhibitors increases ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information], which may increase the risk of exposure-related adverse reactions. Reduce the Jakafi dosage when used concomitantly with strong CYP3A4 inhibitors except in patients with aGVHD or cGVHD [see Dosage and Administration (2.5) in Full Prescribing Information]. Strong CYP3A4 Inducers Concomitant use of Jakafi with strong CYP3A4 inducers may decrease ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information], which may reduce efficacy of Jakafi. Monitor patients frequently and adjust the Jakafi dose based on safety and efficacy [see Clinical Pharmacology (12.3) in Full Prescribing Information]. USE IN SPECIFIC POPULATIONS Pregnancy: Risk Summary When pregnant rats and rabbits were administered ruxolitinib during the period of organogenesis adverse developmental outcomes occurred at doses associated with maternal toxicity (see Data). There are no studies with the use of Jakafi in pregnant women to inform drug-associated risks. The background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk in the U.S. general population of major birth defects is 2% to 4% and miscarriage is 15% to 20% of clinically recognized pregnancies. Data: Animal Data Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There were no treatment-related malformations. Adverse developmental outcomes, such as decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). Lactation: Risk Summary No data are available regarding the presence of ruxolitinib in human milk, the effects on the breast fed child, or the effects on milk production. Ruxolitinib and/or its metabolites were present in the milk of lactating rats (see Data). Because many drugs are present in human milk and because of the potential for thrombocytopenia and anemia shown for Jakafi in human studies, discontinue breastfeeding during treatment with Jakafi and for two weeks after the final dose. Data: Animal Data Lactating rats were administered a single dose of [14C]-labeled ruxolitinib (30 mg/kg) on postnatal Day 10, after which plasma and milk samples were collected for up to 24 hours. The AUC for total radioactivity in milk was approximately 13-fold the maternal plasma AUC. Additional analysis showed the presence of ruxolitinib and several of its metabolites in milk, all at levels higher than those in maternal plasma. Pediatric Use The safety and effectiveness of Jakafi for treatment of myelofibrosis or polycythemia vera in pediatric patients have not been established. The safety and effectiveness of Jakafi for treatment of

steroid-refractory aGVHD has been established for treatment of children 12 years and older. Use of Jakafi in pediatric patients with steroid-refractory aGVHD is supported by evidence from adequate and well-controlled trials of Jakafi in adults [see Clinical Studies (14.3) in Full Prescribing Information] and additional pharmacokinetic and safety data in pediatric patients. The safety and effectiveness of Jakafi for treatment of steroid-refractory aGVHD has not been established in pediatric patients younger than 12 years old. The safety and effectiveness of Jakafi for treatment of cGVHD after failure of one or two lines of systemic therapy has been established for treatment of children 12 years and older. Use of Jakafi in pediatric patients with cGVHD after failure of one or two lines of systemic therapy is supported by evidence from adequate and well-controlled trials of Jakafi in adults and adolescents [see Clinical Studies (14.3, 14.4) in Full Prescribing Information] and additional pharmacokinetic and safety data in pediatric patients. The safety and effectiveness of Jakafi for treatment of cGVHD has not been established in pediatric patients younger than 12 years old. Jakafi was evaluated in a single-arm, dose-escalation study (NCT01164163) in 27 pediatric patients with relapsed or refractory solid tumors (Cohort A) and 20 with leukemias or myeloproliferative neoplasms (Cohort B). The patients had a median age of 14 years (range, 2 to 21 years) and included 18 children (age 2 to < 12 years), and 14 adolescents (age 12 to < 17 years). The dose levels tested were 15, 21, 29, 39, or 50 mg/m2 twice daily in 28-day cycles with up to 6 patients per dose group. Overall, 38 (81%) patients were treated with no more than a single cycle of Jakafi, while 3, 1, 2, and 3 patients received 2, 3, 4, and 5 or more cycles, respectively. A protocol-defined maximal tolerated dose was not observed, but since few patients were treated for multiple cycles, tolerability with continued use was not assessed adequately to establish a recommended Phase 2 dose higher than the recommended dose for adults. The safety profile in children was similar to that seen in adults. Juvenile Animal Toxicity Data Administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. When administered starting at postnatal day 7 (the equivalent of a human newborn) at doses of 1.5 to 75 mg/kg/day, evidence of fractures occurred at doses ≥ 30 mg/kg/day, and effects on body weight and other bone measures [e.g., bone mineral content, peripheral quantitative computed tomography, and x-ray analysis] occurred at doses ≥ 5 mg/kg/day. When administered starting at postnatal day 21 (the equivalent of a human 2-3 years of age) at doses of 5 to 60 mg/kg/day, effects on body weight and bone occurred at doses ≥ 15 mg/kg/day, which were considered adverse at 60 mg/kg/day. Males were more severely affected than females in all age groups, and effects were generally more severe when administration was initiated earlier in the postnatal period. These findings were observed at exposures that are at least 27% the clinical exposure at the maximum recommended dose of 25 mg twice daily. Geriatric Use Of the total number of patients with MF in clinical studies with Jakafi, 52% were 65 years and older, while 15% were 75 years and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Clinical studies of Jakafi in patients with aGVHD did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Of the total number of patients with cGVHD treated with Jakafi in clinical trials, 11% were 65 years and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment Total exposure of ruxolitinib and its active metabolites increased with moderate (CLcr 30 to 59 mL/min) and severe (CLcr 15 to 29 mL/min) renal impairment, and ESRD (CLcr less than 15 mL/min) on dialysis [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Modify Jakafi dosage as recommended [see Dosage and Administration (2.6) in full Prescribing Information]. Hepatic Impairment Exposure of ruxolitinib increased with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment [see Clinical Pharmacology (12.3) in full Prescribing Information].

Reduce Jakafi dosage as recommended in patients with MF or PV with hepatic impairment [see Dosage and Administration (2.6) in full Prescribing Information]. Reduce Jakafi dosage as recommended for patients with Stage 4 liver aGVHD. Monitor blood counts more frequently for toxicity and modify the Jakafi dosage for adverse reactions if they occur for patients with Score 3 liver cGVHD [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3) in full Prescribing Information]. OVERDOSAGE There is no known antidote for overdoses with Jakafi. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anemia and thrombocytopenia. Appropriate supportive treatment should be given. Hemodialysis is not expected to enhance the elimination of Jakafi. Jakafi is a registered trademark of Incyte. U.S. Patent Nos. 7598257; 8415362; 8722693; 8822481; 8829013; 9079912; 9814722; 10016429 © 2011-2021 Incyte Corporation. Revised: September 2021 PLR-JAK-00054

FOCUS GUIDE 2022

ALL IN ONE DIAGNOSTIC SOLUTIONS

COVID-19 TESTING

FLU AND RESPIRATORY

SPIROMETRY

BRAIN FUNCTION ASSESSMENT

CRYOSURGERY

HEMATOLOGY ANALYZERS

STREP TEST

CHEMISTRY ANALYZERS

DIABETES

IMMUNOASSAY ANALYZERS

TOXICOLOGY

CLIA WAIVED

EXAM ROOM EQUIPMENT

LABORATORY SERVICES

URINALYSIS

2022 · BUYERS GUIDE | 31

PRODUCT FOCUS

PRODUCT

PRODUCT FOCUS

ALL-IN-ONE DIAGNOSTIC SOLUTIONS

OPTIMIZE PRODUCTIVITY AND EXPAND YOUR PRACTICE From MedPod

The Medpod Medical Cart optimizes productivity and load balancing by enabling access to remote physicians during high volume periods or to reach low-density populations. Medpod’s proprietary software integrates with a wide range of professional medical devices and gives the remote provider control of the devices to conduct an examination that is on par with a faceto-face visit. Patient images, audio and data can be captured, annotated, tagged and uploaded in real-time or stored and forwarded into the EHR by either remote or local provider.

1024

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DEFINING MOBILE TELEDIAGNOSTICS From MedPod

With the ability to deploy into a medical ofﬁce in less than 2 minutes, MobileDoc is the ultimate portable practice. Revolutionary in its compact and mobile design, MobileDoc integrates best-in-class professional medicalgrade devices with state-of-the-art HD video and EHR connectivity. Physicians can provide care remotely that is on par or better than a face-to-face visit, including conducting basic exams, checking vitals, and performing specialty testing—shattering the boundaries of traditional care.

1025

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BRAIN FUNCTION ASSESSMENT

EARLIER DETECTION OF MEMORY LOSS, DEMENTIA AND OTHER COGNITIVE DISORDERS From Morningside Medical 1026

Standard cognitive screening tools like MMSE/ MOCA are exactly that; screening tools. The technology is there to test the patients that fail these screening tools right in your office. Get clinically relevant information about your patients’ brain performance, while generating additional reimbursement for the practice, leading to earlier diagnosis and more accurate referrals. Aids in clear diagnosis • Strong Reimbursement • Improves Patient Outcomes • Easy for any staff to perform • Cognitive Testing / Mental Health • Sudomotor Function / Neuropathy • Vestibular Testing / Fall Prevention • Autonomic Function / Cardiovascular Risk

View Brochures, Videos & More at POR.io Enter Number 1026 in the Search Area 32 | PHYSICIANS OFFICE RESOURCE

Let us help you make COVID-19 testing and daily compliant reporting to state and federal agencies easy!

Point-of-Care Testing

Physician Office Laboratories

Urgent Care & Emergency Centers

Pain Management Laboratories

Cost-effective, Easy to Use Lab Data Management and Compliance Software Solutions POC to High Complexity Testing manage patient lab test orders to completed results • Automatically Connect to EHR - post results to patient chart • Document lab compliance requirements - QC and patient results all in one place • Instruments of Choice

Medicus POC LIS

1027

EHR

COVID-19

Hematology

Flu/Strep/RSV

Chemistry

Glucose

Urinalysis

PT/INR

Link Your Lab For more information, please call 888.643.8081 or email sales@medicuslis.com

medicuslis.com

PRODUCT FOCUS

CHEMISTRY ANALYZERS

EASY, INTEGRATED WITH-PATIENT TESTING I-STAT SYSTEM Easy, Integrated With-Patient Testing From Abbott Point of Care

i-STAT System from Point of Care at Abbott

The handheld i-STAT System offers a broad menu of diagnostic tests

at i-STAT the patient’s side inoffers just minutes. Withmenu just a few of blood, The handheld System a broad of drops diagnostic tests at the the i-STAT System delivers real time, lab-accurate results for a wide patient’s siderange in just minutes. With just a few drops of blood, the i-STAT of tests, including chemistries, blood gas, coagulation, cardiac markers, more. Minimize delays and wasted with on-side System delivers realand time, lab-accurate results for atime wide range of tests, tests. Easy, intuitive operation. including chemistries, blood gas, coagulation, cardiac markers, and more. Minimize delays and wasted withproduct on-siteinformation, tests. Easy, For intended use andtime complete visit intuitive pointof- operation.

1028

care.abbott.

For intended use and complete product information, visit pointofcare.abbott.

For in vitro diagnostic use only. This material is intended for a U.S.

For in vitro diagnostic use only. This material is intended for a U.S. audience only. audience only. i-STAT is a trademark of Abbott. Physician Office Rei-STAT is a trademark of Abbott. Physician Office Resource i-STAT Product Description – US 3064.REV1 08/20

source i-STAT Product Description — US 3064.REV1 08/20

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FULL COMPLEMENT OF CLIA-WAIVED BLOOD CHEMISTRY TESTS PICCOLO XPRESS® CHEMISTRY ANALYZER From Abbott Point of Care

The Piccolo Xpress Chemistry Analyzer provides physician offices with lab-accurate results for a broad range of CLIA-waived general chemistry tests, including metabolic panels, lipids, live, and kidney function, and more with just 100 microliters of blood. Easy to use, the PIccolo Xpress provides results during a patient’s visit, accelerating treatment decisions, increasing efficiency, and supporting patient satisfaction. Automated quality control on every test helps ensure accuracy.

Full Compleme Piccolo Xpress

The Piccolo Xpr lab-accurate res tests, including 1029with just 100 mi results during a efficiency, and s every test helps

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1030

For in vitro diagnostic u Piccolo Xpress is a reg Physician Office Resou

TOXICOLOGY SCREENING SIMPLIFIED ABBOTT’S IMMTOX 270 BENCHTOP ANALYZER NOW WITH 14 ASSAYS CLIA CATEGORIZED AS MODERATE COMPLEXITY From Abbott

The ImmTox270 benchtop analyzer offers comprehensive toxicology screening solutions for physician offices, treatment centers and independent laboratories. Broad test menu with over 20 assays to choose from including 14 that are now available as moderately complex. With complete laboratory solutions from consultation to licensure, and compliance the Abbott Clinical Laboratory Solutions team has you covered.

View Brochures, Videos & More at POR.io Enter Number 1030 in the Search Area 34 | PHYSICIANS OFFICE RESOURCE

TOXICOLOGY URINE DRUG SCREENING REAGENTS 1031

From Abbott

Prescription drug misuse and illicit drug abuse is a growing public health challenge in this country. Building a test profile that covers highly misused drugs has never been so vital. With over 20 relevant assays to choose from Abbott’s suite of Immunalysis reagents allows you to easily screen for relevant substances. Our complete line of assays, calibrators, and controls enables you to implement an efficient drug screening program in office.

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ENVOY500+ DELIVERING PROVEN RESULTS IN CLINICAL CHEMISTRY

1032

From EliTech

The fully automated Envoy500+ is designed to deliver the performance of a large floor model analyzer but provides the cost efficiency of a benchtop analyzer (TPH approx. 490). It enables accurate treatment decisions sooner. Envoy500+ delivers savings the laboratory requires with the following features positive sample and reagent identification, clot detection, liquid level sensing, dry ISE module, reusable glass cuvettes, and many more.

View Brochures, Videos & More at POR.io Enter Number 1032 in the Search Area

1033

DRUGS OF ABUSE TESTING AND ROUTINE CHEMISTRY PANELS ON A SINGLE ANALYZER From Carolina Liquid Chemistries

Carolina Liquid Chemistries Corp. announces the successful launch of Medica Corporation’s high-speed benchtop analyzer, the EasyRA®. The updated analyzer now operates at a photometric rate of up to 240 tests per hour or up to 480 tests per hour with ISE. The EasyRA urine drug screening and general chemistry reagents are CLIA categorized as moderately complex. This all-in-one system allows clinical laboratories to screen for drugs of abuse in urine while also allowing healthcare providers to assess routine chemistry panels on a single analyzer.

View Brochures, Videos & More at POR.io Enter Number 1033 in the Search Area

2022 · BUYERS GUIDE | 35

PRODUCT FOCUS

CHEMISTRY ANALYZERS

PRODUCT FOCUS

CHEMISTRY ANALYZERS

PENTRA C400 CHEMISTRY ANALYZER From HORIBA Medical

One benchtop, not a whole lab! No water system, drain or special electrical connected required to operate the Pentra C400 chemistry analyzer. Now you can have the power of a floor model analyzer on the benchtop! The Pentra C400 chemistry system processes up to 420 tests/hr including ISEs and offers routine metabolic assays, TDMs, DAUs and Adulterants, HbA1c and Vitamin D tests. With 40 open channels, you can add much more for a complete menu to meet your practice needs.

1034

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RX DAYTONA+

From Randox Laboratories

The RX daytona+ is a fully automated, benchtop, clinical chemistry analyzer capable of performing high quality testing, with a combined throughput of 450 tests per hour, for accurate results you can trust. The most versatile analyzer in its class, the RX daytona+ combines robust hardware and intuitive software with the world leading RX series test menu for unrivaled performance, with direct HbA1c testing capabilities.

View Brochures, Videos & More at POR.io Enter Number 1035 in the Search Area

1035

RX IMOLA

From HORIBA Medical

1036

The RX imola is a cost-effective system that delivers consistent high-quality results. Capable of handling the workload of a medium to high throughout laboratory and a combined throughput of 560 tests per hour, the RX imola provides rapid, comprehensive testing on a small footprint analyzer when it matters most, with direct HbA1c testing capabilities.

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36 | PHYSICIANS OFFICE RESOURCE

1037

Full Complement of CLIA-waived Blood Chemistry Tests FULL COMPLEMENT OF CLIA-WAIVED BLOOD CHEMISTRY Piccolo Xpress® Chemistry Analyzer from Abbott

TESTS PICCOLO XPRESS® CHEMISTRY ANALYZER

FromPiccolo AbbottXpress Point ofChemistry Care The Analyzer provides physician offices with lab-accurate results for a broad range of CLIA-waived general The Piccolo Xpress Chemistry Analyzer provides physician offices withchemistry tests, including metabolic panels, liver, andgeneral kidneychemistry function, and more lab-accurate results for a broad range lipids, of CLIA-waived tests,just including metabolic panels, lipids, live,to and kidney and more with 100 microliters of blood. Easy use, the function, Piccolo Xpress provides with just 100 microliters of blood. Easy to use, the PIccolo Xpress provides results during a patient’s visit, accelerating treatment decisions, increasing results during a patient’s visit, accelerating treatment decisions, increasing efficiency, andsupporting supporting patient satisfaction. Automated quality on efficiency, and patient satisfaction. Automated quality controlcontrol on every testhelps helps ensure accuracy. every test ensure accuracy. View Brochures, Moreis at POR.io For in vitro diagnostic useVideos only. This& material intended for a U.S. audience only. Piccolo is a registered of Abaxis, Inc. and distributed by Abbott Point of Care. EnterXpress Number 1037 intrademark the Search Area Physician Office Resource Piccolo Product Description – US 3065.REV1 08/20

LAB-ACCURATE RESULTS FOR ACR AND HBA1C From Abbott

With its compact size and panel of tests, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital out-patient clinics. From just a small urine or fingerstick whole blood sample, labaccurate results for ACR and HbA1c are made available during the consultation.

View Brochures, Videos & More at POR.io Enter Number 1038 in the Search Area

1038

ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OF-CARE LIPID TESTING From Abbott

The CLIA-waived Alere Cholestech LDX™ Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing. Results are easy to obtain. Fingerstick sampling and a small sample size (40μL) makes results less painful and time consuming.

1039

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2022 · BUYERS GUIDE | 37

PRODUCT FOCUS

CLIA WAIVED

PRODUCT FOCUS

CLIA WAIVED

BD VERITOR™ PLUS SYSTEM From BD Veritor™

1040

The BD Veritor™ Plus System is a portable, easy-to-use, testing solution for SARS-COV-2*, Flu A+ B and other respiratory tract infections that delivers results in 15 minutes or less. It features two analysis modes that adapt to your workflow, online education tools, and optional reporting capabilities including the BD Synapsys™ Informatics Solution—making it the point-ofcare diagnostic tool you won’t want to be without. *EUA authorized by FDA

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CLIA-WAIVED BIOFIRE® FILMARRAY® RESPIRATORY PANEL (RP) EZ From BioFire

The BioFire RP EZ accurately detects and identifies 14 viral and bacterial pathogens—not just Flu A and Flu B—so you can provide your patients with the right treatment, the first time. The test is easy and can be performed right in your office or clinic, with results in about an hour. The BioFire RP EZ is designed to run on a single computer/instrument configuration (EZ Configuration) of the BioFire® FilmArray® 2.0 System.

104 1

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ACUCY INFLUENZA A&B TEST From Sekisui Diagnostics

The Acucy™ Influenza A&B Test is for the rapid, qualitative detection of influenza A and B viral nucleoprotein antigens from both nasal and nasopharyngeal swabs. Utilizing the Acucy™ Reader in either the point-of-care or laboratory setting, workflow flexibility is achieved with both Read Now and Walk Away features. The combination provides clinicians with standardized and definitive result interpretation.

1042 View Brochures, Videos & More at POR.io Enter Number 1042 in the Search Area

38 | PHYSICIANS OFFICE RESOURCE

OSOM ULTRA PLUS FLU A&B TEST From Sekisui Diagnostics 1043

Stronger Clinical Performance Takes Lateral Flow Testing To The Next Level. Providing superior rapid results at the point-of-care. Fast, easy, cost effective so you can test and treat in one visit. • High Performance- Equivalent or exceeding the performance of reader devices, without the need for an instrument • Results in 10 minutes • OSOM® Custom Care- Exceptional Support/Training by licensed medical technologists and experienced healthcare professionals • Made in the USA

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OSOM® BVBLUE®

1044

From Sekisui Diagnostics The OSOM® BVBLUE® detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus. OSOM® BVBLUE® is more sensitive than Amsel criteria providing physicians with a more accurate diagnosis to treat and minimize serious health consequences such as early spontaneous preterm births and miscarriage.

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1045

ULTRA HCG COMBO TEST From Sekisui Diagnostics

The OSOM® Ultra hCG Combo test is a simple immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Internal studies have confirmed that the OSOM® Ultra hCG Combo test does not have a false negative result from hCG variants providing physicians with a higher level of confidence.

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2022 · BUYERS GUIDE | 39

PRODUCT FOCUS

CLIA WAIVED

NOW APPROVED IN PD-L1+ STAGE II-IIIA NSCLC

ADVANCING THE STANDARD OF ADJUVANT TREATMENT TECENTRIQ: The first and only FDA-approved adjuvant immunotherapy in PD-L1+ (TC ≥1%) NSCLC, offering new hope in the fight against stage II-IIIA* disease1,2 PD-L1=programmed death-ligand 1; TC=tumor cells. *Per the Union for International Cancer Control/American Joint Committee on Cancer staging system, 7th edition.

Indication TECENTRIQ, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥1% of tumor cells, as determined by an FDA-approved test.

Important Safety Information Severe and Fatal Immune-Mediated Adverse Reactions TECENTRIQ is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions can occur in any organ system or tissue and at any time after starting TECENTRIQ. While immune-mediated adverse reactions usually manifest during treatment with TECENTRIQ, they can also manifest after discontinuation of treatment. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of TECENTRIQ. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. In general, if TECENTRIQ requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less, then initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis • TECENTRIQ can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation • Immune-mediated pneumonitis occurred in 3.8% (19/495) of patients with NSCLC receiving TECENTRIQ alone as adjuvant treatment, including fatal (0.2%), Grade 4 (0.2%), and Grade 3 (0.6%) adverse reactions Immune-Mediated Colitis • TECENTRIQ can cause immune-mediated colitis. Colitis can present with diarrhea, abdominal pain, and lower gastrointestinal (GI) bleeding. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies • Immune-mediated colitis occurred in 1% (26/2616) of patients receiving TECENTRIQ alone, including Grade 3 (0.5%) and Grade 2 (0.3%) adverse reactions Immune-Mediated Hepatitis • TECENTRIQ can cause immune-mediated hepatitis • Immune-mediated hepatitis occurred in 1.8% (48/2616) of patients receiving TECENTRIQ alone, including fatal (<0.1%), Grade 4 (0.2%), Grade 3 (0.5%), and Grade 2 (0.5%) adverse reactions Please see additional Important Safety Information and Brief Summary of Prescribing Information on the following pages.

Important Safety Information (cont’d)

Immune-Mediated Endocrinopathies Adrenal Insufficiency • TECENTRIQ can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated • Adrenal insufficiency occurred in 1.2% (6/495) of patients with NSCLC receiving TECENTRIQ alone as adjuvant treatment, including Grade 3 (0.4%) adverse reactions Hypophysitis • TECENTRIQ can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated • Hypophysitis occurred in <0.1% (2/2616) of patients receiving TECENTRIQ alone, including Grade 2 (1 patient, <0.1%) adverse reactions Thyroid Disorders • TECENTRIQ can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or medical management for hyperthyroidism as clinically indicated • Thyroiditis occurred in 1.2% (6/495) of patients with NSCLC receiving TECENTRIQ alone as adjuvant treatment, including Grade 2 (0.4%) adverse reactions. Thyroiditis led to withholding of TECENTRIQ in 1 patient • Hyperthyroidism occurred in 6% (32/495) of patients with NSCLC receiving TECENTRIQ alone as adjuvant treatment, including Grade 3 (0.4%) adverse reactions • Hypothyroidism occurred in 17% (86/495) of patients with NSCLC receiving TECENTRIQ alone as adjuvant treatment Type 1 Diabetes Mellitus, Which Can Present With Diabetic Ketoacidosis • Initiate treatment with insulin as clinically indicated • Type 1 diabetes mellitus occurred in 0.3% (7/2616) of patients receiving TECENTRIQ alone, including Grade 3 (0.2%) and Grade 2 (<0.1%) adverse reactions Immune-Mediated Nephritis With Renal Dysfunction • TECENTRIQ can cause immune-mediated nephritis • Immune-mediated nephritis with renal dysfunction occurred in <0.1% (1/2616) of patients receiving TECENTRIQ alone, and this adverse reaction was a Grade 3 (<0.1%) adverse reaction Immune-Mediated Dermatologic Adverse Reactions • TECENTRIQ can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), DRESS, and toxic epidermal necrolysis (TEN), has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes • Immune-mediated dermatologic adverse reactions occurred in 0.6% (15/2616) of patients receiving TECENTRIQ alone, including Grade 3 (<0.1%) and Grade 2 (0.2%) adverse reactions Other Immune-Mediated Adverse Reactions • The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received TECENTRIQ or were reported with the use of other PD-1/PD-L1 blocking antibodies – Cardiac/Vascular: Myocarditis, pericarditis, vasculitis – Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy

– Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss – Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis – Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic – Endocrine: Hypoparathyroidism – Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection Infusion-Related Reactions • TECENTRIQ can cause severe or life-threatening infusion-related reactions. Interrupt, slow the rate of infusion, or permanently discontinue based on severity • Infusion-related reactions occurred in 1.3% of patients, including Grade 3 (0.2%) reactions Complications of Allogeneic HSCT After PD-1/PD-L1 Inhibitors • Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody • Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT Embryo-Fetal Toxicity • TECENTRIQ can cause fetal harm when administered to a pregnant woman • Verify pregnancy status of females of reproductive potential prior to initiating TECENTRIQ • Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose Most Common Adverse Reactions The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ alone were fatigue/asthenia (48%), decreased appetite (25%), nausea (24%), cough (22%), and dyspnea (22%). Use in Specific Populations Advise female patients not to breastfeed during treatment and for at least 5 months after the last dose. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555. Please see Brief Summary of Prescribing Information on the following pages. References: 1. TECENTRIQ Prescribing Information. Genentech, Inc. 2. Felip E, Altorki N, Zhou C, et al; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021;398:1344-1357.

Learn more at TECENTRIQ-HCP.com/adjNSCLC

TECENTRIQ® [atezolizumab] Initial U.S. Approval: 2016

This is a brief summary of information about TECENTRIQ. Before prescribing, please see full Prescribing Information. 1 INDICATIONS AND USAGE 1.1 Urothelial Carcinoma TECENTRIQ is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: • are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area), as determined by an FDA-approved test [see Dosage and Administration (2.1)], or • are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Non-Small Cell Lung Cancer • TECENTRIQ, as a single-agent, is indicated as adjuvant treatment following resection and platinumbased chemotherapy for adult patients with stage II to IIIA [see Clinical Studies (14.2)] non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test [see Dosage and Administration (2.1)]. • TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations [see Dosage and Administration (2.1)]. • TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the firstline treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. • TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the firstline treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. • TECENTRIQ, as a single-agent, is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. 1.3 Small Cell Lung Cancer TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). 1.4 Hepatocellular Carcinoma TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 1.5 Melanoma TECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage and Administration (2.1)]. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Severe and Fatal Immune-Mediated Adverse Reactions TECENTRIQ is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immunemediated adverse reactions. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting a PD-1/PD-L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/ PD-L1 blocking antibodies. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue TECENTRIQ depending on severity [see Dosage and Administration (2.3)]. In general, if TECENTRIQ requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis TECENTRIQ can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. TECENTRIQ as a Single Agent: Immune-mediated pneumonitis occurred in 3% (83/2616) of patients receiving TECENTRIQ as a single agent, including fatal (<0.1%), Grade 4 (0.2%), Grade 3 (0.8%), and Grade 2 (1.1%) adverse reactions. Pneumonitis led to permanent discontinuation of TECENTRIQ in 0.5% and withholding of TECENTRIQ in 1.5% of patients. Systemic corticosteroids were required in 55% (46/83) of patients with pneumonitis. Pneumonitis resolved in 69% of the 83 patients. Of the 39 patients in whom TECENTRIQ was withheld for pneumonitis, 25 reinitiated TECENTRIQ after symptom improvement; of these, 4% had recurrence of pneumonitis. In IMpower010 immune-mediated pneumonitis occurred in 3.8% (19/495) of patients receiving TECENTRIQ as a single agent, including fatal (0.2%), Grade 4 (0.2%), and Grade 3 (0.6%) adverse reactions. Pneumonitis led to permanent discontinuation of TECENTRIQ in 2.2% and withholding of TECENTRIQ in 0.8% of patients. Systemic corticosteroids were required in 63% (12/19) of patients with pneumonitis. Pneumonitis resolved in 84% of the 19 patients. TECENTRIQ in Combination with Cobimetinib and Vemurafenib: Immune-mediated pneumonitis occurred in 13% (29/230) of patients receiving TECENTRIQ in combination with cobimetinib and vemurafenib, including Grade 3 (1.3%) and Grade 2 (7%) adverse reactions. Pneumonitis led to permanent discontinuation of TECENTRIQ in 2.6% and withholding of TECENTRIQ in 7.4% of patients. Systemic corticosteroids were required in 55% (16/29) of patients with pneumonitis. Pneumonitis resolved in 97% of the 29 patients. Of the 17 patients in whom TECENTRIQ was withheld for pneumonitis, 10 reinitiated TECENTRIQ after symptom improvement; of these, 50% had recurrence of pneumonitis. Immune-Mediated Colitis TECENTRIQ can cause immune-mediated colitis. Colitis can present with diarrhea, abdominal pain, and lower gastrointestinal (GI) bleeding. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. TECENTRIQ as a Single Agent: Immune-mediated colitis occurred in 1% (26/2616) of patients receiving TECENTRIQ as a single agent, including Grade 3 (0.5%) and Grade 2 (0.3%) adverse reactions. Colitis led to permanent discontinuation

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of TECENTRIQ in 0.2% and withholding of TECENTRIQ in 0.5% of patients. Systemic corticosteroids were required in 50% (13/26) of patients with colitis. Colitis resolved in 73% of the 26 patients. Of the 12 patients in whom TECENTRIQ was withheld for colitis, 8 reinitiated treatment with TECENTRIQ after symptom improvement; of these, 25% had recurrence of colitis. Immune-Mediated Hepatitis TECENTRIQ can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 1.8% (48/2616) of patients receiving TECENTRIQ as a single agent, including fatal (<0.1%), Grade 4 (0.2%), Grade 3 (0.5%), and Grade 2 (0.5%) adverse reactions. Hepatitis led to permanent discontinuation of TECENTRIQ in 0.2% and withholding of TECENTRIQ in 0.2% of patients. Systemic corticosteroids were required in 25% (12/48) of patients with hepatitis. Hepatitis resolved in 50% of the 48 patients. Of the 6 patients in whom TECENTRIQ was withheld for hepatitis, 4 reinitiated treatment with TECENTRIQ after symptom improvement; of these, none had recurrence of hepatitis. TECENTRIQ in Combination with Cobimetinib and Vemurafenib: Immune-mediated hepatitis occurred in 6.1% (14/230) of patients receiving TECENTRIQ in combination with cobimetinib and vemurafenib, including Grade 4 (1.3%), Grade 3 (1.7%) and Grade 2 (1.3%) adverse reactions. Hepatitis led to permanent discontinuation of TECENTRIQ in 2.2% and withholding of TECENTRIQ in 1.7% of patients. Systemic corticosteroids were required in 50% (7/14) of patients with hepatitis. Hepatitis resolved in 93% of the 14 patients. Of the 4 patients in whom TECENTRIQ was withheld for hepatitis, 3 reinitiated TECENTRIQ after symptom improvement; of these, 33% had recurrence of hepatitis. Immune-Mediated Endocrinopathies Adrenal Insufficiency TECENTRIQ can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold or permanently discontinue TECENTRIQ depending on severity [see Dosage and Administration (2.3)]. Adrenal insufficiency occurred in 0.4% (11/2616) of patients receiving TECENTRIQ as a single agent, including Grade 3 (<0.1%) and Grade 2 (0.2%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of TECENTRIQ in one patient and withholding of TECENTRIQ in one patient. Systemic corticosteroids were required in 82% (9/11) of patients with adrenal insufficiency; of these, 3 patients remained on systemic corticosteroids. The single patient in whom TECENTRIQ was withheld for adrenal insufficiency did not reinitiate TECENTRIQ. In IMpower010 immune-mediated adrenal insufficiency occurred in 1.2% (6/495) of patients receiving TECENTRIQ as a single agent, including Grade 3 (0.4%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of TECENTRIQ in 0.6% and withholding of TECENTRIQ in 0.2% of patients. Systemic corticosteroids were required in 83% (5/6) of patients with adrenal insufficiency; of these, 4 patients remained on systemic corticosteroids. Hypophysitis TECENTRIQ can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue TECENTRIQ depending on severity [see Dosage and Administration (2.3)]. Hypophysitis occurred in <0.1% (2/2616) of patients receiving TECENTRIQ as a single agent, including Grade 2 (1 patient, <0.1%) adverse reactions. Hypophysitis led to permanent discontinuation of TECENTRIQ in one patient and no patients required withholding of TECENTRIQ. Systemic corticosteroids were required in 50% (1/2) of patients with hypophysitis. Hypophysitis did not resolve in these 2 patients. Thyroid disorders TECENTRIQ can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or medical management for hyperthyroidism as clinically indicated. Withhold or permanently discontinue TECENTRIQ depending on severity [see Dosage and Administration (2.3)]. Thyroiditis: Thyroiditis occurred in 0.2% (4/2616) of patients receiving TECENTRIQ as a single agent, including Grade 2 (<0.1%) adverse reactions. Thyroiditis did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in one patient. Hormone replacement therapy was required in 75% (3/4) of patients with thyroiditis. Systemic corticosteroids were required in 25% (1/4) of patients with thyroiditis. Thyroiditis resolved in 50% of patients. The single patient in whom TECENTRIQ was withheld for thyroiditis reinitiated TECENTRIQ; this patient did not have recurrence of thyroiditis. In IMpower010, thyroiditis occurred in 1.2% (6/495) of patients receiving TECENTRIQ as a single agent, including Grade 2 (0.4%) adverse reactions. Thyroiditis led to withholding of TECENTRIQ in one patient. Hormone replacement therapy was required in 67% (4/6) of patients with thyroiditis. Systemic corticosteroids were required in 33% (2/6) of patients with thyroiditis. Thyroiditis resolved in 50% of patients. Hyperthyroidism: TECENTRIQ as a Single Agent: Hyperthyroidism occurred in 0.8% (21/2616) of patients receiving TECENTRIQ as a single agent, including Grade 2 (0.4%) adverse reactions. Hyperthyroidism did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in 0.1% of patients. Antithyroid therapy was required in 29% (6/21) of patients with hyperthyroidism. Of these 6 patients, the majority remained on antithyroid treatment. Of the 3 patients in whom TECENTRIQ was withheld for hyperthyroidism, one patient reinitiated TECENTRIQ; this patient did not have recurrence of hyperthyroidism. In IMpower010 hyperthyroidism occurred in 6% (32/495) of patients receiving TECENTRIQ as a single agent, including Grade 3 (0.4%) adverse reactions. Hyperthyroidism led to permanent discontinuation of TECENTRIQ in 0.8% and withholding of TECENTRIQ in 2.8% of patients. Antithyroid therapy was required in 38% (12/32) of patients with hyperthyroidism. Of these 12 patients, the majority remained on antithyroid treatment. Of the 14 patients in whom TECENTRIQ was withheld for hyperthyroidism, 9 patients reinitiated TECENTRIQ. TECENTRIQ in Combination with Cobimetinib and Vemurafenib: Hyperthyroidism occurred in 19% (43/230) of patients receiving TECENTRIQ in combination with cobimetinib and vemurafenib, including Grade 3 (0.9%) and Grade 2 (7.8%) adverse reactions. Hyperthyroidism led to permanent discontinuation of TECENTRIQ in 0.4% and withholding of TECENTRIQ in 10% of patients. Antithyroid therapy was required in 53% (23/43) of patients with hyperthyroidism. Of these 23 patients, the majority remained on antithyroid treatment. Of the 24 patients in whom TECENTRIQ was withheld for hyperthyroidism, 18 patients reinitiated TECENTRIQ; of these, 28% had recurrence of hyperthyroidism. Hypothyroidism: TECENTRIQ as a Single Agent: Hypothyroidism occurred in 4.9% (128/2616) of patients receiving TECENTRIQ as a single agent, including Grade 3 (0.2%) and Grade 2 (3.4%) adverse reactions. Hypothyroidism did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in 0.6% of patients. Hormone replacement therapy was required in 81% (104/128) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 17 patients in whom TECENTRIQ was withheld for hypothyroidism, 8 reinitiated TECENTRIQ after symptom improvement. In IMpower010 hypothyroidism occurred in 17% (86/495) of patients receiving TECENTRIQ as a single agent. Hypothyroidism led to permanent discontinuation of TECENTRIQ in 1.6% and withholding of TECENTRIQ in 1.6% of patients. Hormone replacement was required in 57% (49/86) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 8 patients in whom TECENTRIQ was withheld for hypothyroidism, 3 reinitiated TECENTRIQ after symptom improvement. TECENTRIQ in Combination with Platinum-based Chemotherapy: Hypothyroidism occurred in 11% (277/2421) of patients with NSCLC and SCLC receiving TECENTRIQ in combination with platinum-based chemotherapy, including Grade 4 (<0.1%), Grade 3 (0.3%), and

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Grade 2 (5.7%) adverse reactions. Hypothyroidism led to permanent discontinuation of TECENTRIQ in 0.1% and withholding of TECENTRIQ in 1.6% of patients. Hormone replacement therapy was required in 71% (198/277) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 39 patients in whom TECENTRIQ was withheld for hypothyroidism, 9 reinitiated TECENTRIQ after symptom improvement. TECENTRIQ in Combination with Cobimetinib and Vemurafenib: Hypothyroidism occurred in 26% (60/230) of patients receiving TECENTRIQ in combination with cobimetinib and vemurafenib, including Grade 2 (9.1%) adverse reactions. Hypothyroidism did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in 2.6% of patients. Hormone replacement therapy was required in 52% (31/60) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 6 patients in whom TECENTRIQ was withheld for hypothyroidism, 4 reinitiated TECENTRIQ after symptom improvement. The majority of patients with hypothyroidism required long term thyroid replacement. Type 1 Diabetes Mellitus, which can present with Diabetic Ketoacidosis Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue TECENTRIQ depending on severity [see Dosage and Administration (2.3)]. Type 1 diabetes mellitus occurred in 0.3% (7/2616) of patients receiving TECENTRIQ, including Grade 3 (0.2%) and Grade 2 (<0.1%) adverse reactions. Type 1 diabetes mellitus led to permanent discontinuation of TECENTRIQ in one patient and withholding of TECENTRIQ in two patients. Treatment with insulin was required for all patients with confirmed Type 1 diabetes mellitus and insulin therapy was continued long-term. Of the 2 patients in whom TECENTRIQ was withheld for Type 1 diabetes mellitus, both re-initiated TECENTRIQ treatment. Immune-Mediated Nephritis with Renal Dysfunction TECENTRIQ can cause immune-mediated nephritis. TECENTRIQ as a Single Agent: Immune-mediated nephritis with renal dysfunction occurred in <0.1% (1/2616) of patients receiving TECENTRIQ as a single agent, and this adverse reaction was a Grade 3 (<0.1%) adverse reaction. Nephritis led to permanent discontinuation of TECENTRIQ in this patient. This patient required systemic corticosteroids. In this patient, nephritis did not resolve. TECENTRIQ in Combination with Cobimetinib and Vemurafenib: Immune-mediated nephritis with renal dysfunction occurred in 1.3% (3/230) of patients receiving TECENTRIQ in combination with cobimetinib and vemurafenib, including Grade 2 (1.3%) adverse reactions. Nephritis led to permanent discontinuation of TECENTRIQ in 0.4% and withholding of TECENTRIQ in 0.9% of patients. Systemic corticosteroids were required in 67% (2/3) of patients with nephritis. Nephritis resolved in all 3 of these patients. Of the 2 patients in whom TECENTRIQ was withheld for nephritis, both reinitiated TECENTRIQ after symptom improvement and neither had recurrence of nephritis. Immune-Mediated Dermatologic Adverse Reactions TECENTRIQ can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including StevensJohnson syndrome (SJS), DRESS, and toxic epidermal necrolysis (TEN), has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold or permanently discontinue TECENTRIQ depending on severity [see Dosage and Administration (2.3)]. Immune-mediated dermatologic adverse reactions occurred in 0.6% (15/2616) of patients receiving TECENTRIQ as a single agent, including Grade 3 (<0.1%) and Grade 2 (0.2%) adverse reactions. Dermatologic adverse reactions led to permanent discontinuation of TECENTRIQ in 0.1% and withholding of TECENTRIQ in 0.2% of patients. Systemic corticosteroids were required in 20% (3/15) of patients with dermatologic adverse reactions. Dermatologic adverse reactions resolved in 87% of the 15 patients. Of the 4 patients in whom TECENTRIQ was withheld for immune-mediated dermatologic adverse reactions, none re-initiated TECENTRIQ. Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred at an incidence of < 1% (unless otherwise noted) in patients who received TECENTRIQ or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular : Myocarditis, pericarditis, vasculitis. Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy. Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-KoyanagiHarada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis. Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. Endocrine: Hypoparathyroidism. Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection. 5.2 Infusion-Related Reactions TECENTRIQ can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue TECENTRIQ based on the severity [see Dosage and Administration (2.3)]. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. In clinical studies enrolling 2616 patients with various cancers who received TECENTRIQ as a single-agent [see Adverse Reactions (6.1)], infusion-related reactions occurred in 1.3% of patients, including Grade 3 (0.2%). The frequency and severity of infusion-related reactions were similar whether TECENTRIQ was given as a single-agent in patients with various cancers, in combination with other antineoplastic drugs in NSCLC and SCLC, and across the recommended dose range (840 mg Q2W to 1680 mg Q4W). 5.3 Complications of Allogeneic HSCT after PD-1/PD-L1 Inhibitors Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplantrelated complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockage and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT. 5.4 Embryo-Fetal Toxicity Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. There are no available data on the use of TECENTRIQ in pregnant women. Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus resulting in fetal death. Verify pregnancy status of females of reproductive potential prior to initiating TECENTRIQ. Advise females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose [see Use in Specific Populations (8.1, 8.3)]. 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)] • Infusion-Related Reactions [see Warnings and Precautions (5.2)] • Complications of Allogeneic HSCT after PD-1/PD-L1 Inhibitors [see Warnings and Precautions (5.3)]

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6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in WARNINGS AND PRECAUTIONS reflect exposure to TECENTRIQ as a single-agent in 2616 patients in two randomized, active-controlled studies (POPLAR, OAK) and four open-label, single arm studies (PCD4989g, IMvigor210, BIRCH, FIR) which enrolled 524 patients with metastatic urothelial carcinoma, 1636 patients with metastatic NSCLC, and 456 patients with other tumor types. TECENTRIQ was administered at a dose of 1200 mg intravenously every 3 weeks in all studies except PCD4989g. Among the 2616 patients who received a single-agent TECENTRIQ, 36% were exposed for longer than 6 months and 20% were exposed for longer than 12 months. Using the dataset described for patients who received TECENTRIQ as a single-agent, the most common adverse reactions in ≥ 20% of patients were fatigue/asthenia (48%), decreased appetite (25%), nausea (24%), cough (22%), and dyspnea (22%). In addition, the data reflect exposure to TECENTRIQ as a single agent as adjuvant therapy in 495 patients with early stage NSCLC enrolled in a randomized study (IMpower010). In addition, the data reflect exposure to TECENTRIQ in combination with other antineoplastic drugs in 2421 patients with NSCLC (N = 2223) or SCLC (N = 198) enrolled in five randomized, active-controlled trials, including IMpower150, IMpower130 and IMpower133. Among the 2421 patients, 53% were exposed to TECENTRIQ for longer than 6 months and 29% were exposed to TECENTRIQ for longer than 12 months. Among the 2421 patients with NSCLC and SCLC who received TECENTRIQ in combination with other antineoplastic drugs, the most common adverse reactions in ≥20% of patients were fatigue/ asthenia (49%), nausea (38%), alopecia (35%), constipation (29%), diarrhea (28%) and decreased appetite (27%). The data also reflect exposure to TECENTRIQ administered in combination with cobimetinib and vemurafenib in 230 patients enrolled in IMspire150. Among the 230 patients, 62% were exposed to TECENTRIQ for longer than 6 months and 42% were exposed to TECENTRIQ for longer than 12 months. Urothelial Carcinoma Cisplatin-Ineligible Patients with Locally Advanced or Metastatic Urothelial Carcinoma The safety of TECENTRIQ was evaluated in IMvigor210 (Cohort 1), a multicenter, open-label, singlearm trial that included 119 patients with locally advanced or metastatic urothelial carcinoma who were ineligible for cisplatin-containing chemotherapy and were either previously untreated or had disease progression at least 12 months after neoadjuvant or adjuvant chemotherapy [see Clinical Studies (14.1)]. Patients received TECENTRIQ 1200 mg intravenously every 3 weeks until either unacceptable toxicity or disease progression. The median duration of exposure was 15 weeks (0 to 87 weeks). Five patients (4.2%) who were treated with TECENTRIQ experienced one of the following events which led to death: sepsis, cardiac arrest, myocardial infarction, respiratory failure, or respiratory distress. One additional patient (0.8%) was experiencing herpetic meningoencephalitis and disease progression at the time of death. Serious adverse reactions occurred in 37% of patients. The most frequent serious adverse reactions (≥ 2%) were diarrhea, intestinal obstruction, sepsis, acute kidney injury, and renal failure. TECENTRIQ was discontinued for adverse reactions in 4.2% of patients. The adverse reactions leading to discontinuation were diarrhea/colitis (1.7%), fatigue (0.8%), hypersensitivity (0.8%), and dyspnea (0.8%). Adverse reactions leading to interruption occurred in 35% of patients; the most common (≥ 1%) were intestinal obstruction, fatigue, diarrhea, urinary tract infection, infusion-related reaction, cough, abdominal pain, peripheral edema, pyrexia, respiratory tract infection, upper respiratory tract infection, creatinine increase, decreased appetite, hyponatremia, back pain, pruritus, and venous thromboembolism. Tables 4 and 5 summarize the adverse reactions and Grades 3–4 selected laboratory abnormalities, respectively, in patients who received TECENTRIQ in IMvigor210 (Cohort 1). Table 4: Adverse Reactions in ≥ 10% of Patients with Urothelial Carcinoma in IMvigor210 (Cohort 1)

Adverse Reaction

TECENTRIQ N = 119 All Grades (%)

Grades 3–4 (%)

General Fatigue1 52 Peripheral edema2 17 Pyrexia 14 Gastrointestinal Diarrhea3 24 Nausea 22 Vomiting 16 Constipation 15 Abdominal pain4 15 Metabolism and Nutrition Decreased appetite5 24 Musculoskeletal and Connective Tissue Back/Neck pain 18 Arthralgia 13 Skin and Subcutaneous Tissue Pruritus 18 Rash6 17 Infections Urinary tract infection7 17 Respiratory, Thoracic, and Mediastinal Cough8 14 Dyspnea9 12

8 2 0.8 5 2 0.8 2 0.8 3 3 0 0.8 0.8 5 0 0

Includes fatigue, asthenia, lethargy, and malaise Includes edema peripheral, scrotal edema, lymphedema, and edema Includes diarrhea, colitis, frequent bowel movements, autoimmune colitis 4 Includes abdominal pain, upper abdominal pain, lower abdominal pain, and flank pain 5 Includes decreased appetite and early satiety 6 Includes rash, dermatitis, dermatitis acneiform, rash maculo-papular, rash erythematous, rash pruritic, rash macular, and rash papular 7 Includes urinary tract infection, urinary tract infection bacterial, cystitis, and urosepsis 8 Includes cough and productive cough 9 Includes dyspnea and exertional dyspnea 1 2 3

Table 5: Grades 3–4 Laboratory Abnormalities in ≥ 1% of Patients with Urothelial Carcinoma in IMvigor210 (Cohort 1) Laboratory Abnormality Chemistry Hyponatremia

Grades 3–4 (%) 15

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Table 5: Grades 3–4 Laboratory Abnormalities in ≥ 1% of Patients with Urothelial Carcinoma in IMvigor210 (Cohort 1) (continued) Grades 3–4 (%) 10 7 5 4 4 4 3 3 3

Laboratory Abnormality Hyperglycemia Increased Alkaline Phosphatase Increased Creatinine Hypophosphatemia Increased ALT Increased AST Hyperkalemia Hypermagnesemia Hyperbilirubinemia Hematology Lymphopenia Anemia

9 7

Graded per NCI CTCAE v4.0.

Non-Small Cell Lung Cancer (NSCLC) Adjuvant Treatment of Early-stage NSCLC IMpower010 The safety of TECENTRIQ was evaluated in IMpower010, a multicenter, open-label, randomized trial for the adjuvant treatment of patients with stage IB (tumors ≥ 4 cm) - IIIA NSCLC who had complete tumor resection and received up to 4 cycles of cisplatin-based adjuvant chemotherapy. Patients received TECENTRIQ 1200 mg every 3 weeks (n=495) for 1 year (16 cycles), unless disease progression or unacceptable toxicity occurred, or best supportive care [see Clinical Studies (14.2)]. The median number of cycles received was 16 (range: 1, 16). Fatal adverse reactions occurred in 1.8% of patients receiving TECENTRIQ; these included multiple organ dysfunction syndrome, pneumothorax, interstitial lung disease, arrhythmia, acute cardiac failure, myocarditis, cerebrovascular accident, death of unknown cause, and acute myeloid leukemia (1 patient each). Serious adverse reactions occurred in 18% of patients receiving TECENTRIQ. The most frequent serious adverse reactions (>1%) were pneumonia (1.8%), pneumonitis (1.6%), and pyrexia (1.2%). TECENTRIQ was discontinued due to adverse reactions in 18% of patients; the most common adverse reactions (≥1%) leading to TECENTRIQ discontinuation were pneumonitis (2.2%), hypothyroidism (1.6%), increased aspartate aminotranferase (1.4%), arthralgia (1.0%), and increased alanine aminotransferase (1.0%). Adverse reactions leading to interruption of TECENTRIQ occurred in 29% of patients; the most common (>1%) were rash (3.0%), hyperthyroidism (2.8%), hypothyroidism (1.6%), increased AST (1.6%), pyrexia (1.6%), increased ALT (1.4%), upper respiratory tract infection (1.4%), headache (1.2%), peripheral neuropathy (1.2%), and pneumonia (1.2%). Tables 6 and 7 summarize adverse reactions and selected laboratory abnormalities in patients receiving TECENTRIQ in IMpower010. Table 6: Adverse Reactions Occurring in ≥10% of Patients with Early Stage NSCLC Receiving TECENTRIQ in IMpower010 Adverse Reaction*

TECENTRIQ N = 495 All Grades Grades 3–4 (%) (%)

Skin and Subcutaneous Tissue Rash1 17 Pruritus 10 Endocrine Disorders Hypothyroidism2 14 Respiratory, Thoracic and Mediastinal Cough3 16 General Pyrexia4 14 Fatigue5 14 Nervous System Disorders Peripheral neuropathy6 12 Musculoskeletal and Connective Tissue Musculoskeletal pain7 14 Arthralgia8 11

Best Supportive Care N = 495 All Grades Grades 3–4 (%) (%)

Graded per NCI CTCAE v4.0, except for increased creatinine which only includes patients with creatinine increase based on upper limit of normal definition for Grade 1 events (NCI CTCAE v5.0). The denominators used to calculate the rate varied from 78-480 for BSC arm and 483 for atezolizumab are for all tests of interest based on the number of patients with a baseline value and at least one post-treatment value.

Metastatic Chemotherapy-Naïve NSCLC IMpower110 The safety of TECENTRIQ was evaluated in IMpower110, a multicenter, international, randomized, open-label study in 549 chemotherapy-naïve patients with stage IV NSCLC, including those with EGFR or ALK genomic tumor aberrations. Patients received TECENTRIQ 1200 mg every 3 weeks (n=286) or platinum-based chemotherapy consisting of carboplatin or cisplatin with either pemetrexed or gemcitabine (n=263) until disease progression or unacceptable toxicity [see Clinical Studies (14.2)]. IMpower110 enrolled patients whose tumors express PD-L1 (PD-L1 stained ≥ 1% of tumor cells [TC] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 1% of the tumor area). The median duration of exposure to TECENTRIQ was 5.3 months (0 to 33 months). Fatal adverse reactions occurred in 3.8% of patients receiving TECENTRIQ; these included death (reported as unexplained death and death of unknown cause), aspiration, chronic obstructive pulmonary disease, pulmonary embolism, acute myocardial infarction, cardiac arrest, mechanical ileus, sepsis, cerebral infarction, and device occlusion (1 patient each). Serious adverse reactions occurred in 28% of patients receiving TECENTRIQ. The most frequent serious adverse reactions (>2%) were pneumonia (2.8%), chronic obstructive pulmonary disease (2.1%) and pneumonitis (2.1%). TECENTRIQ was discontinued due to adverse reactions in 6% of patients; the most common adverse reactions (≥2 patients) leading to TECENTRIQ discontinuation were peripheral neuropathy and pneumonitis. Adverse reactions leading to interruption of TECENTRIQ occurred in 26% of patients; the most common (>1%) were ALT increased (2.1%), AST increased (2.1%), pneumonitis (2.1%), pyrexia (1.4%), pneumonia (1.4%) and upper respiratory tract infection (1.4%). Tables 8 and 9 summarize adverse reactions and selected laboratory abnormalities in patients receiving TECENTRIQ in IMpower110. Table 8: Adverse Reactions Occurring in ≥10% of Patients with NSCLC Receiving TECENTRIQ in IMpower110

All Grades (%)

0.6

0.8 0.6

2.2 5

0.2 0.2

Hematology Anemia Lymphopenia Chemistry Hypoalbuminemia

0.2

Increased alkaline phosphatase Hyponatremia Increased ALT Increased AST Hyperkalemia Hypocalcemia Increased blood creatinine Hypophosphatemia

9 6

0.2 0

Table 7: Laboratory Abnormalities Worsening from Baseline Occurring in ≥20% of Patients with Early Stage NSCLC Receiving TECENTRIQ in IMpower010 TECENTRIQ 2

Best Supportive Care2

All Grades (%)

Grades 3–4 (%)

All Grades (%)

Grades 3–4 (%)

Increased aspartate aminotransferase

2.5

Increased alanine aminotransferase

3.3

0.4

Hyperkalemia Increased blood creatinine

24 31

3.5 0.2

15 23

2.5 0.2

Chemistry

Grades 3–4 (%)

0.3 1.0 0

34 22 12

1.9 0.8 0.8

1.4 0

34 9

4.2 0.4

0.7

0.7 0.3

10 10

0 0

Table 9: Laboratory Abnormalities Worsening from Baseline Occurring in ≥20% of Patients Receiving TECENTRIQ in IMpower110

0.8 0.6

All Grades (%)

Graded per NCI CTCAE v4.0

0 0

Grades 3–4 (%)

Gastrointestinal Nausea 14 Constipation 12 Diarrhea 11 General Fatigue/asthenia 25 Pyrexia 14 Metabolism and Nutrition Decreased appetite 15 Respiratory, Thoracic and Mediastinal Dyspnea 14 Cough 12

1.4 0.6

0.4

Platinum-Based Chemotherapy N = 263

TECENTRIQ N = 286

Adverse Reaction

1.2 0

*Graded per NCI CTCAE v4.0 1 Includes rash, dermatitis, genital rash, skin exfoliation, rash maculo-papular, rash erythematous, rash papular, lichen planus, eczema asteatotic, dermatitis exfoliative, palmar-plantar erythrodysaesthesia syndrome, dyshidrotic eczema, eczema, drug eruption, rash pruritic, toxic skin eruption, dermatitis acneiform 2 Includes hypothyroidism, autoimmune hypothyroidism, primary hypothyroidism, blood thyroid stimulating hormone increased 3 Productive cough, upper airway cough syndrome, cough 4 Includes pyrexia, body temperature increased, hyperthermia 5 Includes fatigue, asthenia 6 Includes paraesthesia, neuropathy peripheral, peripheral sensory neuropathy, hypoaesthesia, polyneuropathy, dysaesthesia, neuralgia, axonal neuropathy 7 Includes myalgia, bone pain, back pain, spinal pain, musculoskeletal chest pain, pain in extremity, neck pain, noncardiac chest pain, musculoskeletal discomfort, musculoskeletal stiffness, musculoskeletal pain 8 Includes arthralgia, arthritis

Laboratory Abnormality1

Platinum-Based Chemotherapy

TECENTRIQ Laboratory Abnormality

All Grades (%)

Grades 3–4 (%)

All Grades (%)

Grades 3–4 (%)

69 47

1.8 9

94 59

20 17

0.4

2.5

1.2

44 38 36 29 24 24 23

9 3.2 3.2 3.9 1.4 0.7 3.6

36 32 32 36 24 33 21

7 0.8 0.8 2.7 2.7 1.5 2

Each test incidence is based on the number of patients who had at least one on-study laboratory measurement available: TECENTRIQ (range: 278-281); platinum-based chemotherapy (range: 256-260). Graded per NCI CTCAE v4.0. Increased blood creatinine only includes patients with test results above the normal range.

IMpower150 The safety of TECENTRIQ with bevacizumab, paclitaxel and carboplatin was evaluated in IMpower150, a multicenter, international, randomized, open-label trial in which 393 chemotherapy-naïve patients with metastatic non-squamous NSCLC received TECENTRIQ 1200 mg with bevacizumab 15 mg/kg, paclitaxel 175 mg/m2 or 200 mg/m2, and carboplatin AUC 6 mg/mL/min intravenously every 3 weeks for a maximum of 4 or 6 cycles, followed by TECENTRIQ 1200 mg with bevacizumab 15 mg/kg intravenously every 3 weeks until disease progression or unacceptable toxicity [see Clinical Studies (14.2)]. The median duration of exposure to TECENTRIQ was 8.3 months in patients receiving TECENTRIQ with bevacizumab, paclitaxel, and carboplatin. Fatal adverse reactions occurred in 6% of patients receiving TECENTRIQ; these included hemoptysis, febrile neutropenia, pulmonary embolism, pulmonary hemorrhage, death, cardiac arrest, cerebrovascular accident, pneumonia, aspiration pneumonia, chronic obstructive pulmonary disease, intracranial hemorrhage, intestinal angina, intestinal ischemia, intestinal obstruction and aortic dissection. Serious adverse reactions occurred in 44%. The most frequent serious adverse reactions (>2%) were febrile neutropenia, pneumonia, diarrhea, and hemoptysis. TECENTRIQ was discontinued due to adverse reactions in 15% of patients; the most common adverse reaction leading to discontinuation was pneumonitis (1.8%). Adverse reactions leading to interruption of TECENTRIQ occurred in 48%; the most common (>1%) were neutropenia, thrombocytopenia, fatigue/asthenia, diarrhea, hypothyroidism, anemia, pneumonia, pyrexia, hyperthyroidism, febrile neutropenia, increased ALT, dyspnea, dehydration and proteinuria.

Tables 10 and 11 summarize adverse reactions and laboratory abnormalities in patients receiving TECENTRIQ with bevacizumab, paclitaxel, and carboplatin in IMpower150.

Table 10: Adverse Reactions Occurring in ≥15% of Patients with NSCLC Receiving TECENTRIQ in IMpower150

Adverse Reaction

TECENTRIQ with Bevacizumab, Bevacizumab, Paclitaxel and Paclitaxel, and Carboplatin Carboplatin N = 393 N = 394 All Grades (%)

Nervous System Neuropathy1 56 Headache 16 General Fatigue/Asthenia 50 Pyrexia 19 Skin and Subcutaneous Tissue Alopecia 48 Rash2 23 Musculoskeletal and Connective Tissue Myalgia/Pain3 42 Arthralgia 26 Gastrointestinal Nausea 39 Diarrhea4 33 Constipation 30 Vomiting 19 Metabolism and Nutrition Decreased appetite 29 Vascular Hypertension 25 Respiratory Cough 20 Epistaxis 17 Renal 16 Proteinuria5

Grades 3–4 (%)

All Grades (%)

Grades 3–4 (%)

3 0.8

47 13

3 0

6 0.3

46 9

6 0.5

0 2

46 10

0 0.3

3 1

34 22

2 1

4 6 0.3 2

32 25 23 18

2 0.5 0.3 1

0.8

0.8 1

19 22

0.3 0.3

Graded per NCI CTCAE v4.0 1 Includes neuropathy peripheral, peripheral sensory neuropathy, hypoesthesia, paraesthesia, dysesthesia, polyneuropathy 2 Includes rash, rash maculo-papular, drug eruption, eczema, eczema asteatotic, dermatitis, contact dermatitis, rash erythematous, rash macular, pruritic rash, seborrheic dermatitis, dermatitis psoriasiform 3 Includes pain in extremity, musculoskeletal chest pain, musculoskeletal discomfort, neck pain, back pain, myalgia, and bone pain 4 Includes diarrhea, gastroenteritis, colitis, enterocolitis 5 Data based on Preferred Terms since laboratory data for proteinuria were not systematically collected

Table 11: Laboratory Abnormalities Worsening from Baseline Occurring in ≥20% of Patients with NSCLC Receiving TECENTRIQ in IMpower150

Laboratory Abnormality

TECENTRIQ with Bevacizumab, Paclitaxel, and Carboplatin

Bevacizumab, Paclitaxel and Carboplatin

All Grades (%)

Grades 3–4 (%)

All Grades (%)

Grades 3–4 (%)

83 52 48

10 31 17

83 45 38

9 26 13

Hematology Anemia Neutropenia Lymphopenia Chemistry Hyperglycemia Increased BUN Hypomagnesemia Hypoalbuminemia Increased AST Hyponatremia

61 52 42 40 40 38

0 NA1 2 3 4 10

60 44 36 31 28 36

0 NA1 1 2 0.8 9

Increased Alkaline Phosphatase

Increased ALT Increased TSH Hyperkalemia Increased Creatinine Hypocalcemia Hypophosphatemia Hypokalemia Hyperphosphatemia

37 30 28 28 26 25 23 25

6 NA1 3 1 3 4 7 NA1

28 20 25 19 21 18 14 19

0.5 NA1 2 2 3 4 4 NA1

Among patients receiving TECENTRIQ, 55% were exposed for 6 months or longer and 3.5% were exposed for greater than one year. Fatal adverse reactions occurred in 5.3% of patients receiving TECENTRIQ; these included pneumonia (1.1%), pulmonary embolism (0.8%), myocardial infarction (0.6%), cardiac arrest (0.4%), pneumonitis (0.4%) and sepsis, septic shock, staphylococcal sepsis, aspiration, respiratory distress, cardiorespiratory arrest, ventricular tachycardia, death (not otherwise specified), and hepatic cirrhosis (0.2% each). Serious adverse reactions occurred in 51% of patients receiving TECENTRIQ. The most frequent serious adverse reactions (≥2%) were pneumonia (6%), diarrhea (3%), lung infection (3%), pulmonary embolism (3%), chronic obstructive pulmonary disease exacerbation (2.5%), dyspnea (2.3%), and febrile neutropenia (1.9%). TECENTRIQ was discontinued due to adverse reactions in 13% of patients; the most common adverse reactions leading to discontinuation were pneumonia (0.8%), pulmonary embolism (0.8%), fatigue (0.6%), dyspnea (0.6%), pneumonitis (0.6%), neutropenia (0.4%), nausea (0.4%), renal failure (0.4%), cardiac arrest (0.4%), and septic shock (0.4%). Adverse reactions leading to interruption of TECENTRIQ occurred in 62% of patients; the most common (>1%) were neutropenia, thrombocytopenia, anemia, diarrhea, fatigue/asthenia, pneumonia, dyspnea, pneumonitis, pyrexia, nausea, acute kidney injury, vomiting, pulmonary embolism, arthralgia, infusionrelated reaction, abdominal pain, chronic obstructive pulmonary disease exacerbation, dehydration, and hypokalemia. Tables 12 and 13 summarize adverse reactions and laboratory abnormalities in patients receiving TECENTRIQ with paclitaxel protein-bound and carboplatin in IMpower130. Table 12: Adverse Reactions Occurring in ≥20% of Patients with NSCLC Receiving TECENTRIQ in IMpower130

Adverse Reaction

IMpower130 The safety of TECENTRIQ with paclitaxel protein-bound and carboplatin was evaluated in IMpower130, a multicenter, international, randomized, open-label trial in which 473 chemotherapy-naïve patients with metastatic non-squamous NSCLC received TECENTRIQ 1200 mg and carboplatin AUC 6 mg/mL/min intravenously on Day 1 and paclitaxel protein-bound 100 mg/m2 intravenously on Day 1, 8, and 15 of each 21-day cycle for a maximum of 4 or 6 cycles, followed by TECENTRIQ 1200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity [see Clinical Studies (14.2)].

Paclitaxel Protein-Bound and Carboplatin N = 232

All Grades (%)

Grades 3–4 (%)

All Grades (%)

Grades 3–4 (%)

3.4 6 1.1 2.7

46 32 31 19

2.2 6 0 2.2

0.4

2.5

2.2

4.9 0.6

25 17

1.3 0

General Fatigue/Asthenia 61 Gastrointestinal Nausea 50 Diarrhea1 43 Constipation 36 Vomiting 27 Musculoskeletal and Connective Tissue Myalgia/Pain2 38 Nervous System Neuropathy3 33 Respiratory, Thoracic and Mediastinal Dyspnea4 32 Cough 27 Skin and Subcutaneous Tissue Alopecia

Rash5 Metabolism and Nutrition Decreased appetite

0.6

0.9

2.1

2.2

Graded per NCI CTCAE v4.0 1 Includes diarrhea, colitis, and gastroenteritis 2 Includes back pain, pain in extremity, myalgia, musculoskeletal chest pain, bone pain, neck pain and musculoskeletal discomfort 3 Includes neuropathy peripheral, peripheral sensory neuropathy, hypoesthesia, paresthesia, dysesthesia, polyneuropathy 4 Includes dyspnea, dyspnea exertional and wheezing 5 Includes rash, rash maculo-papular, eczema, rash pruritic, rash erythematous, dermatitis, dermatitis contact, drug eruption, seborrheic dermatitis and rash macular.

Table 13: Laboratory Abnormalities Worsening from Baseline Occurring in ≥20% of Patients Receiving TECENTRIQ in IMpower130

Laboratory Abnormality

Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: TECENTRIQ with bevacizumab, paclitaxel, and carboplatin range: 337-380); bevacizumab, paclitaxel, and carboplatin (range: 337-382). Graded per NCI CTCAE v4.0 1 NA = Not applicable. NCI CTCAE does not provide a Grades 3-4 definition for these laboratory abnormalities

TECENTRIQ with Paclitaxel Protein-Bound and Carboplatin N = 473

Hematology Anemia Neutropenia Thrombocytopenia Lymphopenia Chemistry Hyperglycemia Hypomagnesemia Hyponatremia Hypoalbuminemia Increased ALT Hypocalcemia Hypophosphatemia Increased AST Increased TSH Hypokalemia Increased Alkaline Phosphatase Increased Blood Creatinine Hyperphosphatemia

TECENTRIQ with Paclitaxel Protein-Bound and Carboplatin N = 473

Paclitaxel Protein-Bound and Carboplatin N = 232

All Grades (%)

Grades 3–4 (%)

All Grades (%)

Grades 3–4 (%)

92 75 73 71

33 50 19 23

87 67 59 61

25 39 13 16

75 50 37 35 31 31 29 28 26

8 3.4 9 1.3 2.8 2.6 6 2.2 NA1

66 42 28 31 24 27 20 24

8 3.2 7 0 3.9 1.8 3.2 1.8

5 24

NA1 4.4

2.6

1.3

23 21

2.8 NA1

16 13

0.4 NA1

Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: TECENTRIQ with paclitaxel protein-bound and carboplatin (range: 423 - 467); paclitaxel proteinbound and carboplatin (range: 218 - 229). Graded per NCI CTCAE v4.0. 1 NA = Not applicable. NCI CTCAE does not provide a Grades 3-4 definition for these laboratory abnormalities

Previously Treated Metastatic NSCLC The safety of TECENTRIQ was evaluated in OAK, a multicenter, international, randomized, open-label trial in patients with metastatic NSCLC who progressed during or following a platinum-containing regimen, regardless of PD-L1 expression [see Clinical Studies (14.2)]. A total of 609 patients received TECENTRIQ 1200 mg intravenously every 3 weeks until unacceptable toxicity, radiographic progression, or clinical progression or docetaxel (n=578) 75 mg/m2 intravenously every 3 weeks until unacceptable toxicity or disease progression. The study excluded patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids. The median duration of exposure was 3.4 months (0 to 26 months) in TECENTRIQ-treated patients and 2.1 months (0 to 23 months) in docetaxel-treated patients. The study population characteristics were: median age of 63 years (25 to 85 years), 46% age 65 years or older, 62% male, 71% White, 20% Asian, 68% former smoker, 16% current smoker, and 63% had ECOG performance status of 1. Fatal adverse reactions occurred in 1.6% of patients; these included pneumonia, sepsis, septic shock, dyspnea, pulmonary hemorrhage, sudden death, myocardial ischemia or renal failure. Serious adverse reactions occurred in 33.5% of patients. The most frequent serious adverse reactions (>1%) were pneumonia, sepsis, dyspnea, pleural effusion, pulmonary embolism, pyrexia and respiratory tract infection. TECENTRIQ was discontinued due to adverse reactions in 8% of patients. The most common adverse reactions leading to TECENTRIQ discontinuation were fatigue, infections and dyspnea. Adverse reactions leading to interruption of TECENTRIQ occurred in 25% of patients; the most common (>1%) were pneumonia, liver function test abnormality, dyspnea, fatigue, pyrexia, and back pain. Tables 14 and 15 summarize adverse reactions and laboratory abnormalities, respectively, in OAK. Table 14: Adverse Reactions Occurring in ≥10% of Patients with NSCLC Receiving TECENTRIQ in OAK

Adverse Reaction General Fatigue/Asthenia1 Pyrexia Respiratory Cough2 Dyspnea Metabolism and Nutrition Decreased appetite Musculoskeletal Myalgia/Pain3 Arthralgia Gastrointestinal Nausea Constipation Diarrhea Skin Rash4

TECENTRIQ N = 609

Docetaxel N = 578

Grades 3-4 (%)

All Grades (%)

Grades 3-4 (%)

44 18

4 <1

53 13

6 <1

26 22

<1 2.8

21 21

<1 2.6

1.6

20 12

1.3 0.5

20 10

<1 0.2

18 18 16

<1 <1 <1

23 14 24

<1 <1 2

Graded per NCI CTCAE v4.0 1 Includes fatigue and asthenia 2 Includes cough and exertional cough 3 Includes musculoskeletal pain, musculoskeletal stiffness, musculoskeletal chest pain, myalgia 4 Includes rash, erythematous rash, generalized rash, maculopapular rash, papular rash, pruritic rash, pustular rash, pemphigoid

Table 15: Laboratory Abnormalities Worsening from Baseline Occurring in ≥20% of Patients with NSCLC Receiving TECENTRIQ in OAK Laboratory Abnormality Hematology Anemia Lymphocytopenia Chemistry Hypoalbuminemia Hyponatremia Increased Alkaline Phosphatase Increased AST Increased ALT Hypophosphatemia Hypomagnesemia Increased Creatinine

Adverse Reaction

TECENTRIQ with Carboplatin and Etoposide N = 198 All Grades (%)

Placebo with Carboplatin and Etoposide N = 196

Grades 3–4 (%)

All Grades (%)

Grades 3–4 (%)

General Fatigue/asthenia Gastrointestinal Nausea Constipation Vomiting Skin and Subcutaneous Tissue Alopecia Metabolism and Nutrition

38 26 20

1 1 2

33 30 17

1 1 3

Decreased appetite

Graded per NCI CTCAE v4.0

Table 17: Laboratory Abnormalities Worsening from Baseline Occurring in ≥20% of Patients with SCLC Receiving TECENTRIQ in IMpower133

All Grades (%)

TECENTRIQ

Table 16: Adverse Reactions Occurring in ≥20% of Patients with SCLC Receiving TECENTRIQ in IMpower133

Docetaxel

All Grades (%)

Grades 3-4 (%)

All Grades (%)

Grades 3-4 (%)

67 49

3 14

82 60

7 21

48 42

4 7

50 31

3 6

31 27 27 26 23

3 3 5 1 2

16 14 23 21 16

0.5 0.5 4 1 1

Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: TECENTRIQ (range: 546–585) and docetaxel (range: 532–560). Graded according to NCI CTCAE version 4.0

Small Cell Lung Cancer (SCLC) The safety of TECENTRIQ with carboplatin and etoposide was evaluated in IMpower133, a randomized, multicenter, double-blind, placebo-controlled trial in which 198 patients with ES-SCLC received TECENTRIQ 1200 mg and carboplatin AUC 5 mg/mL/min on Day 1 and etoposide 100 mg/m2 intravenously on Days 1, 2 and 3 of each 21-day cycle for a maximum of 4 cycles, followed by TECENTRIQ 1200 mg every 3 weeks until disease progression or unacceptable toxicity [see Clinical Studies (14.3)]. Among 198 patients receiving TECENTRIQ, 32% were exposed for 6 months or longer and 12% were exposed for 12 months or longer. Fatal adverse reactions occurred in 2% of patients receiving TECENTRIQ. These included pneumonia, respiratory failure, neutropenia, and death (1 patient each). Serious adverse reactions occurred in 37% of patients receiving TECENTRIQ. Serious adverse reactions in >2% were pneumonia (4.5%), neutropenia (3.5%), febrile neutropenia (2.5%), and thrombocytopenia (2.5%). TECENTRIQ was discontinued due to adverse reactions in 11% of patients. The most frequent adverse reaction requiring permanent discontinuation in >2% of patients was infusion-related reactions (2.5%). Adverse reactions leading to interruption of TECENTRIQ occurred in 59% of patients; the most common (>1%) were neutropenia (22%), anemia (9%), leukopenia (7%), thrombocytopenia (5%), fatigue (4.0%), infusion-related reaction (3.5%), pneumonia (2.0%), febrile neutropenia (1.5%), increased ALT (1.5%), and nausea (1.5%). Tables 16 and 17 summarize adverse reactions and laboratory abnormalities, respectively, in patients who received TECENTRIQ with carboplatin and etoposide in IMpower133.

Laboratory Abnormality Hematology Anemia Neutropenia Thrombocytopenia Lymphopenia Chemistry Hyperglycemia

TECENTRIQ with Carboplatin and Etoposide

Placebo with Carboplatin and Etoposide

All Grades (%)

Grades 3–4 (%)

All Grades (%)

Grades 3–4 (%)

94 73 58 46

17 45 20 14

93 76 53 38

19 48 17 11 8

Increased Alkaline Phosphatase

Hyponatremia Hypoalbuminemia Decreased TSH2

34 32 28 31 26 26 22 22 21 21

15 1 NA1 5 3 3 1 4 NA1 NA1

33 30 15 35 28 31 21 15 23 7

11 0 NA1 6 5 1 2 1 NA1 NA1

Hypomagnesemia Hypocalcemia Increased ALT Increased AST Increased Blood Creatinine Hyperphosphatemia Increased TSH2

Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: TECENTRIQ (range: 181-193); Placebo (range: 181-196). Graded per NCI CTCAE v4.0 1 NA = Not applicable. 2 TSH = thyroid-stimulating hormone. NCI CTCAE v4.0 does not include these laboratories.

Hepatocellular Carcinoma (HCC) The safety of TECENTRIQ in combination with bevacizumab was evaluated in IMbrave150, a multicenter, international, randomized, open-label trial in patients with locally advanced or metastatic or unresectable hepatocellular carcinoma who have not received prior systemic treatment [see Clinical Studies (14.4)]. Patients received 1,200 mg of TECENTRIQ intravenously followed by 15 mg/kg bevacizumab (n=329) every 3 weeks, or 400 mg of sorafenib (n=156) given orally twice daily, until disease progression or unacceptable toxicity. The median duration of exposure to TECENTRIQ was 7.4 months (range: 0-16 months) and to bevacizumab was 6.9 months (range: 0-16 months). Fatal adverse reactions occurred in 4.6% of patients in the TECENTRIQ and bevacizumab arm. The most common adverse reactions leading to death were gastrointestinal and esophageal varices hemorrhage (1.2%) and infections (1.2%). Serious adverse reactions occurred in 38% of patients in the TECENTRIQ and bevacizumab arm. The most frequent serious adverse reactions (≥ 2%) were gastrointestinal hemorrhage (7%), infections (6%), and pyrexia (2.1%). Adverse reactions leading to discontinuation of TECENTRIQ occurred in 9% of patients in the TECENTRIQ and bevacizumab arm. The most common adverse reactions leading to TECENTRIQ discontinuation were hemorrhages (1.2%), including gastrointestinal, subarachnoid, and pulmonary hemorrhages; increased transaminases or bilirubin (1.2%); infusion-related reaction/cytokine release syndrome (0.9%); and autoimmune hepatitis (0.6%). Adverse reactions leading to interruption of TECENTRIQ occurred in 41% of patients in the TECENTRIQ and bevacizumab arm; the most common (≥ 2%) were liver function laboratory abnormalities including increased transaminases, bilirubin, or alkaline phosphatase (8%); infections (6%); gastrointestinal hemorrhages (3.6%); thrombocytopenia/decreased platelet count (3.6%); hyperthyroidism (2.7%); and pyrexia (2.1%). Immune-related adverse reactions requiring systemic corticosteroid therapy occurred in 12% of patients in the TECENTRIQ and bevacizumab arm. Tables 18 and 19 summarize adverse reactions and laboratory abnormalities, respectively, in patients who received TECENTRIQ and bevacizumab in IMbrave150.

Table 18: Adverse Reactions Occurring in ≥10% of Patients with HCC Receiving TECENTRIQ in IMbrave150

Adverse Reaction

TECENTRIQ in combination with Bevacizumab (n = 329) All Grades2 (%)

Grades 3–42 (%)

Vascular Disorders Hypertension 30 15 General Disorders and Administration Site Conditions Fatigue/asthenia1 26 2 Pyrexia 18 0 Renal and Urinary Disorders Proteinuria 20 3 Investigations Weight Decreased 11 0 Skin and Subcutaneous Tissue Disorders Pruritus 19 0 Rash 12 0 Gastrointestinal Disorders Diarrhea 19 1.8 Constipation 13 0 Abdominal Pain 12 0 Nausea 12 0 Vomiting 10 0 Metabolism and Nutrition Disorders Decreased Appetite 18 1.2 Respiratory, Thoracic and Mediastinal Disorders Cough 12 0 Epistaxis 10 0 Injury, Poisoning and Procedural Complications Infusion-Related Reaction 11 2.4 1 2

Sorafenib (n=156) All Grades2 (%)

Grades 3–42 (%)

32 10

6 0

0.6

10 17

0 2.6

49 14 17 16 8

5 0 0 0 0

3.8

10 4.5

0 0

AST (10%), increased lipase (9%), increased amylase (7%), pneumonitis (5%), increased CPK (4.3%), diarrhea (3.5%), pneumonia (3.5%), asthenia (3%), rash (3%), influenza (3%), arthralgia (2.6%), fatigue (2.2%), dyspnea (2.2%), cough (2.2%), peripheral edema (2.2%), uveitis (2.2%), bronchitis (2.2%), hypothyroidism (2.2%), and respiratory tract infection (2.2%). Tables 20 and 21 summarize the incidence of adverse reactions and laboratory abnormalities in Study IMspire150. Table 20: Adverse Reactions Occurring in ≥10% of Patients on the TECENTRIQ plus Cobimetinib and Vemurafenib Arm or the Placebo plus Cobimetinib and Vemurafenib Arm and at a Higher Incidence (Between Arm Difference of ≥ 5% All Grades or ≥ 2% Grades 3-4 TECENTRIQ in IMspire150)

Adverse Reaction

All Grades (%)

Table 19: Laboratory Abnormalities Worsening from Baseline Occurring in ≥20% of Patients with HCC Receiving TECENTRIQ in IMbrave150

Laboratory Abnormality

Grade 3–4 (%)

Skin and Subcutaneous Tissue Disorders Rash1 75 27 Pruritus 26 <1 Photosensitivity reaction 21 <1 General Disorders and Administration Site Conditions Fatigue2 51 3 Pyrexia3 49 1.7 Edema4 26 <1 Gastrointestinal Disorders Hepatotoxicity5 50 21 Nausea 30 <1 Stomatitis6 23 1.3 Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain7 62 4.3 Endocrine Disorders Hypothyroidism8 22 0 Hyperthyroidism 18 <1 Injury, Poisoning and Procedural Complications Infusion-related reaction9 10 2.6 Respiratory, Thoracic and Mediastinal Disorders Pneumonitis10 12 1.3 Vascular Disorders Hypertension11 17 10

Includes fatigue and asthenia Graded per NCI CTCAE v4.0

TECENTRIQ in combination with Bevacizumab (n=329)

TECENTRIQ in combination with Placebo with Cobimetinib and Cobimetinib and Vemurafenib Vemurafenib (n=230) (n=281) All Grades (%)

Grade 3–4 (%)

72 17 25

23 <1 3.2

45 35 21

1.8 2.1 0

36 32 15

13 2.5 <1

3.2

10 8

0 0

Includes rash, rash maculo-papular, dermatitis acneiform, rash macular, rash erythematous, eczema, skin exfoliation, rash papular, rash pustular, palmar-plantar erythrodysaesthesia syndrome, dermatitis, dermatitis contact, erythema multiforme, rash pruritic, drug eruption, nodular rash, dermatitis allergic, exfoliative rash, dermatitis exfoliative generalised and rash morbilliform 2 Includes fatigue, asthenia and malaise 3 Includes pyrexia and hyperpyrexia 4 Includes edema peripheral, lymphoedema, oedema, face oedema, eyelid oedema, periorbital oedema, lip oedema and generalised oedema 5 Includes alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, transaminases increased, hepatitis, hepatic enzyme increased, hepatotoxicity, hypertransaminasaemia, bilirubin conjugated increased, hepatocellular injury, hyperbilirubinaemia, liver function test increased, hepatic failure, hepatitis fulminant and liver function test abnormal 6 Includes stomatitis, mucosal inflammation, aphthous ulcer, mouth ulceration, cheilitis and glossitis 7 Includes arthralgia, myalgia, pain in extremity, back pain, musculoskeletal pain, arthritis, neck pain, musculoskeletal chest pain, musculoskeletal stiffness, bone pain, spinal pain, immune-mediated arthritis, joint stiffness and non-cardiac chest pain 8 Includes hypothyroidism and blood thyroid stimulating hormone increased 9 Includes infusion related reaction and hypersensitivity 10 Includes pneumonitis and interstitial lung disease 11 Includes hypertension, blood pressure increased, hypertensive crisis 1

Sorafenib (n=156)

All Grades1 (%)

Grades 3–41 (%)

All Grades1 (%)

Chemistry Increased AST

Increased Alkaline Phosphatase

4.6

Increased ALT Decreased Albumin Decreased Sodium Increased Glucose Decreased Calcium Decreased Phosphorus Increased Potassium Hypomagnesemia Hematology Decreased Platelet Decreased Lymphocytes Decreased Hemoglobin Increased Bilirubin Decreased Leukocyte Decreased Neutrophil

62 60 54 48 30 26 23 22

8 1.5 13 9 0.3 4.7 1.9 0

70 54 49 43 35 58 16 22

4.6 0.7 9 4.6 1.3 16 2 0

68 62 58 57 32 23

7 13 3.1 8 3.4 2.3

63 58 62 59 29 16

4.6 11 3.9 14 1.3 1.1

Grades 3–41 (%)

Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: TECENTRIQ plus bevacizumab (222-323) and sorafenib (90-153) 1 Graded per NCI CTCAE v4.0

Melanoma The safety of TECENTRIQ, administered with cobimetinib and vemurafenib was evaluated in IMspire150, a double-blind, randomized (1:1), placebo-controlled study conducted in patients with previously untreated BRAF V600 mutation-positive metastatic or unresectable melanoma [see Clinical Studies (14.5)]. Patients received TECENTRIQ with cobimetinib and vemurafenib (N=230) or placebo with cobimetinib and vemurafenib (n=281). Among the 230 patients who received TECENTRIQ administered with cobimetinib and vemurafenib, the median duration of exposure to TECENTRIQ was 9.2 months (range: 0-30 months) to cobimetinib was 10.0 months (range: 1-31 months) and to vemurafenib was 9.8 months (range: 1-31 months). Fatal adverse reactions occurred in 3% of patients in the TECENTRIQ plus cobimetinib and vemurafenib arm. Adverse reactions leading to death were hepatic failure, fulminant hepatitis, sepsis, septic shock, pneumonia, and cardiac arrest. Serious adverse reactions occurred in 45% of patients in the TECENTRIQ plus cobimetinib and vemurafenib arm. The most frequent (≥ 2%) serious adverse reactions were hepatotoxicity (7%), pyrexia (6%), pneumonia (4.3%), malignant neoplasms (2.2%), and acute kidney injury (2.2%). Adverse reactions leading to discontinuation of TECENTRIQ occurred in 21% of patients in the TECENTRIQ plus cobimetinib and vemurafenib arm. The most frequent (≥ 2%) adverse reactions leading to TECENTRIQ discontinuation were increased ALT (2.2%) and pneumonitis (2.6%). Adverse reactions leading to interruption of TECENTRIQ occurred in 68% of patients in the TECENTRIQ plus cobimetinib and vemurafenib arm. The most frequent (≥ 2%) adverse reactions leading to TECENTRIQ interruption were pyrexia (14%), increased ALT (13%), hyperthyroidism (10%), increased

Clinically important adverse reactions in < 10% of patients who received TECENTRIQ plus cobimetinib and vemurafenib were: Cardiac Disorders: Arrhythmias, ejection fraction decreased, electrocardiogram QT prolonged Eye Disorders: Uveitis Gastrointestinal disorders: Pancreatitis Infections and infestations: Pneumonia, urinary tract infection Metabolism and nutrition disorders: Hyperglycemia Nervous system Disorders: Dizziness, dysgeusia, syncope Respiratory, thoracic and mediastinal disorders: Dyspnea, oropharyngeal pain Skin and Subcutaneous Tissue Disorders: Vitiligo Table 21: Laboratory Abnormalities Worsening from Baseline Occurring in ≥ 20% of Patients Receiving TECENTRIQ Plus Cobimetinib and Vemurafenib Arm or the Placebo Plus Cobimetinib and Vemurafenib Arm and at a Higher Incidence (Between Arm Difference of ≥ 5% All Grades or ≥ 2% Grades 3-4) in IMspire150

Laboratory Abnormality

Hematology Decreased Lymphocytes Decreased Hemoglobin Decreased Platelet Decreased Neutrophils Chemistry Increased Creatine Kinase Increased AST Increased ALT Increased Triacylglycerol Lipase

TECENTRIQ in combination with Placebo with Cobimetinib and Cobimetinib and Vemurafenib Vemurafenib (n=230) (n=281) All Grades (%)

Grade 3–4 (%)

All Grades (%)

Grade 3–4 (%)

80 77 34 26

24 2.6 1.3 2.2

72 72 24 19

17 2.2 0.4 1.5

88 80 79

22 13 18

81 68 62

18 6 12

Table 21: Laboratory Abnormalities Worsening from Baseline Occurring in ≥ 20% of Patients Receiving TECENTRIQ Plus Cobimetinib and Vemurafenib Arm or the Placebo Plus Cobimetinib and Vemurafenib Arm and at a Higher Incidence (Between Arm Difference of ≥ 5% All Grades or ≥ 2% Grades 3-4) in IMspire150 (continued)

Laboratory Abnormality

TECENTRIQ in combination with Placebo with Cobimetinib and Cobimetinib and Vemurafenib Vemurafenib (n=230) (n=281) All Grades (%)

Grades 3–4 (%)

All Grades (%)

Grades 3–4 (%)

Increased Alkaline Phosphatase

2.9

Decreased Phosphorus Increased Amylase Increased Blood Urea Nitrogen Decreased Albumin Increased Bilirubin Decreased Calcium Decreased Sodium

67 51

22 13

64 45

14 13

NA1

43 42 41 40

0.9 3.1 1.3 5

34 33 28 34

1.5 0.7 0 7

Decreased ThyroidStimulating Hormone

NA1

Increased ThyroidStimulating Hormone2

NA1

Decreased Potassium Increased Triiodothyronine Increased Free Thyroxine

36 33 32

5 NA1 NA1

22 18 21

4.3 NA1 NA1

Decreased Total Triiodothyronine

NA1

Increased Potassium Decreased Triiodothyronine Increased Sodium

29 27 20

1.3 NA1 0

19 21 13

1.4 NA1 0.4

Graded per NCI CTCAE v4.0. Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: TECENTRIQ plus cobimetinib and vemurafenib (28-277), placebo plus cobimetinib and vemurafenib arm (25-230). 1 NA= Not applicable. NCI CTCAE v4.0 does not include these laboratories. 2 Increased Thyroid Stimulating Hormone has a difference <5% (All Grades) between arms and is included for clinical completeness.

6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to atezolizumab in the studies described above with the incidence of antibodies in other studies or to other products may be misleading. Among 111 patients in IMvigor210 (Cohort 1), 48% tested positive for treatment-emergent ADA at one or more post-dose time points. Patients who tested positive for treatment-emergent ADA also had decreased systemic atezolizumab exposures. The presence of ADA did not have a clinically significant effect on the incidence or severity of adverse reactions. Among 565 patients with NSCLC in OAK, 30% tested positive for treatment-emergent anti-drug antibodies (ADA) at one or more post-dose time points. The median onset time to ADA formation was 3 weeks. The ability of these binding ADA to neutralize atezolizumab is unknown. Patients who tested positive for treatment-emergent ADA also had decreased systemic atezolizumab exposure [see Clinical Pharmacology (12.3)]. Exploratory analyses showed that the subset of patients who were ADA positive by week 4 (21%; 118/560) appeared to have less efficacy (effect on overall survival) as compared to patients who tested negative for treatment-emergent ADA by week 4 [see Clinical Studies (14.2)]. The presence of ADA did not have a clinically significant effect on the incidence or severity of adverse reactions. Among 487 ADA-evaluable patients with NSCLC who received atezolizumab in IMpower010, 31% (n=152) tested positive for treatment-emergent ADA at one or more post-dose time points. Among 241 patients in the PD-L1 SP263 ≥1% TC Stage II-IIIA population, 28% (n=67) tested positive for treatment-emergent ADA at one or more post-dose time points. Patients who tested positive for treatment-emergent ADA had lower systemic atezolizumab exposure as compared to patients who were ADA-negative [see Clinical Pharmacology (12.3)]. There were insufficient numbers of patients and DFS events in the ADA-positive subgroup (19%; 39/207 by week 7) to determine whether ADA alters the efficacy of atezolizumab. The presence of ADA did not have a clinically significant effect on the incidence or severity of adverse reactions. Among 364 ADA-evaluable patients with NSCLC who received TECENTRIQ with bevacizumab, paclitaxel and carboplatin in IMpower150, 36% (n=132) tested positive for treatment-emergent ADA at one or more post-dose time points and 83% of these 132 patients tested ADA positive prior to receiving the second dose of atezolizumab. The ability of these binding ADA to neutralize atezolizumab is unknown. Patients who tested positive for treatment-emergent ADA had lower systemic atezolizumab exposure as compared to patients who were ADA negative [see Clinical Pharmacology (12.3)]. The presence of ADA did not increase the incidence or severity of adverse reactions [see Clinical Studies (14.2)]. Among 315 ADA-evaluable patients with HCC who received TECENTRIQ and bevacizumab in IMbrave150, 28% (n=88) tested positive for treatment-emergent ADA at one or more post-dose time points and 66% (58/88) of these 88 patients tested ADA-positive prior to receiving the third dose of TECENTRIQ. The ability of these binding ADA to neutralize atezolizumab is unknown. Patients who tested positive for treatment-emergent ADA had lower systemic atezolizumab exposure as compared to patients who were ADA-negative [see Clinical Pharmacology (12.3)]. Exploratory analyses showed that the subset of patients who were ADA-positive by week 6 (20%; 58/288) appeared to have less efficacy (effect on overall survival) as compared to patients who tested negative for treatment-emergent ADA by week 6; [see Clinical Studies (14.4)]. The presence of ADA did not have a clinically significant effect on the incidence or severity of adverse reactions. Among 218 ADA-evaluable patients with melanoma who received TECENTRIQ in combination with cobimetinib and vemurafenib in IMspire150, 13% (n=29) tested positive for treatment-emergent ADA at one or more post-dose time points. Patients who tested positive for treatment-emergent ADA had decreased systemic atezolizumab exposure [see Clinical Pharmacology (12.3)]. There are insufficient numbers of patients with positive ADA to determine whether ADA alters the efficacy or incidence or severity of adverse reactions. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1)], TECENTRIQ can cause fetal harm when administered to a pregnant woman. There are no available data on the use of TECENTRIQ in pregnant women. Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus resulting in fetal death (see Data). Advise females of reproductive potential of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with TECENTRIQ to evaluate its effect on reproduction and fetal development. A literature-based assessment of the effects on reproduction demonstrated that a central function of the PD-L1/PD-1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to a fetus. Blockage of PD-L1 signaling has been shown in murine models of pregnancy to disrupt tolerance to a fetus and to result in an increase in fetal loss; therefore, potential risks of administering TECENTRIQ during pregnancy include increased rates of abortion or stillbirth. As reported in the literature, there were no malformations related to the blockade of PD-L1/PD-1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to atezolizumab may increase the risk of developing immune-mediated disorders or altering the normal immune response. 8.2 Lactation Risk Summary There is no information regarding the presence of atezolizumab in human milk, the effects on the breastfed infant, or the effects on milk production. As human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown. Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise women not to breastfeed during treatment and for at least 5 months after the last dose. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating TECENTRIQ [see Use in Specific Populations (8.1)]. Contraception Females Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months following the last dose. Infertility Females Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment [see Nonclinical Toxicology (13.1)]. 8.4 Pediatric Use The safety and effectiveness of TECENTRIQ have not been established in pediatric patients. The safety and antitumor activity of TECENTRIQ were assessed but not established in a single-arm, multi-center, multi-cohort trial (NCT02541604) in 60 pediatric patients aged 7 months to <17 years with relapsed or progressive solid tumors and lymphomas. No new safety signals were observed in pediatric patients in this study. In pediatric patients who received TECENTRIQ 15 mg/kg with a maximum dose of 1200 mg every 3 weeks, the steady-state exposure (AUC) of atezolizumab in pediatric patients aged 12 years or older was comparable to that in adult patients who received TECENTRIQ 1200 mg every 3 weeks, while the exposure trended lower in pediatric patients less than 12 years old. 8.5 Geriatric Use Of 2616 patients with metastatic urothelial carcinoma, metastatic NSCLC, and other tumor types treated with single agent TECENTRIQ in clinical studies, 49% were 65 years and over and 15% were 75 years and over. Of 2421 patients with NSCLC and SCLC treated with TECENTRIQ in combination with other antineoplastic drugs in clinical studies, 48% were 65 years and over and 10% were 75 years and over. No overall differences in safety or effectiveness were observed between patients aged 65 years or older and younger patients. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Immune-Mediated Adverse Reactions Inform patients of the risk of immune-mediated adverse reactions that may require corticosteroid treatment and interruption or discontinuation of TECENTRIQ, including: • Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath [see Warnings and Precautions (5.1)]. • Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain [see Warnings and Precautions (5.1)]. • Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding [see Warnings and Precautions (5.1)]. • Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypophysitis, hyperthyroidism, hypothyroidism, adrenal insufficiency, or type 1 diabetes mellitus, including diabetic ketoacidosis [see Warnings and Precautions (5.1)]. • Nephritis: Advise patients to contact their healthcare provider immediately for pelvic pain, frequent urination, or unusual swelling. [see Warnings and Precautions (5.1)]. • Dermatologic Adverse Reactions: Advise patients to contact their healthcare provider immediately for generalized rash, skin eruption, or painful skin and mucous membrane lesions [see Warnings and Precautions (5.1)]. • Other Immune-Mediated Adverse Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of other potential immune-mediated adverse reactions [see Warnings and Precautions (5.1)]. Infusion-Related Reactions Advise patients to contact their healthcare provider immediately for signs or symptoms of infusionrelated reactions [see Warnings and Precautions (5.2)]. Complications of Allogeneic HSCT after PD-1/PD-L1 inhibitors Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT[see Warnings and Precautions (5.3)]. Embryo-Fetal Toxicity Advise females of reproductive potential that TECENTRIQ can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4), Use in Specific Populations (8.1, 8.3)]. Advise females of reproductive potential to use effective contraception during treatment and for at least 5 months after the last dose of TECENTRIQ [see Use in Specific Populations (8.3)]. Lactation Advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose [see Use in Specific Populations (8.2)]. Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 M-US-00002930(v6.0) U.S. License No. 1048 TECENTRIQ is a registered trademark of Genentech, Inc. © 2021 Genentech, Inc.

OSOM® TRICHOMONAS RAPID TEST From Sekisui Diagnostics

The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis antigens from vaginal swabs or from the saline solution. The OSOM® Trichomonas Rapid Test is the only CLIA-waived rapid test available today. OSOM® Trichomonas is more sensitive than wet mount due to the assay being able to detect viable and non-viable organisms which offers significant benefits to the patient and clinician alike.

1046

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1047

OSOM® ULTRA STREP A TEST

From Sekisui Diagnostics

The OSOM® Ultra Strep A test is a color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. Shown to be not statistically different than single swab culture. Sensitivity 95.7% and 100% Specificity. Includes two additional test sticks for External QC. CLIA Waived..

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1048

FIRST EVER CLIA WAIVED HEMATOLOGY ANALYZER From Sysmex

Faster test results, clinical decisions and greater practice efficiency are coming to physicians’ offices with the first CLIA-waived CBC analyzer. Hematology diagnostics leader Sysmex is bringing more lab testing to the point of care. One of the most common blood tests can be conducted reliably and accurately on-site, in as few as three minutes. The device’s ease of use and innovative technology means in-house staff can operate it in just a few easy steps, without lengthy certification and training. The new Sysmex XW-100 will improve health care efficiency and patient care.

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2022 · BUYERS GUIDE | 49

PRODUCT FOCUS

CLIA WAIVED

PRODUCT FOCUS

COVID-19 TESTING

BD VERITOR™ PLUS SYSTEM

1049

From BD Veritor™

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BIOFIRE® RESPIRATORY 2.1-EZ (RP2.1-EZ)1 PANEL (EUA)1 From BioFire

SARS-CoV-2 is everyone’s top suspect, but many other respiratory bugs can cause similar, overlapping symptoms. In your clinic, you can test for 19 common respiratory pathogens, including SARS- CoV-2, with the BioFire RP2.1-EZ Panel (EUA)1—now available under an FDA Emergency Use Authorization. Syndromic testing means all it takes is one test and just 45 minutes to round up SARS-CoV-2—and all the other usual respiratory suspects. 1. This test is not FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories.

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1050

EUA POINT-OF-CARE (POC/WAIVED/FINGERSTICK) COVID-19 ANTIBODY TEST NOW AVAILABLE From Carolina Liquid Chemistries

1051

The Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech., distributed in the USA by Carolina Liquid Chemistries, has received FDA Emergency Use Authorization for use with fingerstick whole blood specimens at the point-of-care, i.e. in patient care settings operating under CLIA Certificate of Waiver such as doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab.Refer to carolinachemistries.com for instructions for use, fact sheets, FDA EUA letters, clinical performance studies, and material safety data sheets. Not FDA cleared; only for emergency use under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked.

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GROW WITH CONFIDENCE

Clinical Systems

Scalable Chemistry Solutions for the physicians office laboratories Reliability and consistency The performance and quality are designed into the complete system across all key components: • analyzer & software • liquid stable reagents • calibrators & controls

1052

• ISE (Ion-Selective Electrode) • remote diagnostics

ENVOY500+ Larger volume • 20-80 patients per day

1053

Inquire about our

RENTAL PROGRAMS

Selectra Pro M Mid-volume

Call: 888-755-3916

• 10-40 patients per day

infoUS@elitechgroup.com

1054

Selectra Pro S Compact

www.elitechgroup.com

• 10-15 patients per day ELITechGroup North America, 370 West 1700 South Logan, UT 84321 USA ENVOY500+ is available in the USA only.

PRODUCT FOCUS

COVID-19 TESTING

CARESTART™ COVID-19 ANTIGEN TEST From Mercedes Scientific®

This point-of-care (POC) designated test is one of the top-used amongst our customers. Features/Benefits: • CLIA WAIVED • Results within 15 minutes • Anterior nasal swab specimen collection • Detects SARS-CoV-2 nucleocapsid protein antigen • 87.2% sensitivity and 100% specificity This test is not FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories.

1055

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MEDICUS LIS

From Medicus LIS

1056

If you are considering in-house lab testing, including Covid-19 testing and required reporting to state agencies, connecting Lab to LIS and EHR makes the process of test orders to completed results much easier. Providers receive test results posted to patient charts in real-time, expediting patient care, saving time, money and even preparing for lab test reimbursement goals. Link Your Lab with Medicus LIS today! Contact us: 888-643-8081 sales@medicuslis.com

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CRYOSURGERY

1057

HISTOFREEZER® FLEX From CryoConcepts

This canister-based devices is the latest advance in portable cryosurgery for the physician office. Its advanced design give doctors the option of using cones or buds to deliver the cryogen to the treatment site. There is no risk of cryogen splattering during treatment and our cryogen stays colder versus other products on the market which lead to better first time outcomes.

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52 | PHYSICIANS OFFICE RESOURCE

Solid & Glass Door Refrigerators From 1 to 15 Cu.ft.

Refrigerators & Freezers From 23 to 49 Cu.ft. Refrigeration designed and purpose-built for pharmacy, medication, and vaccination applications to support meeting CDC/VFC vaccine storage guidelines

+/-1ºC variation derived from the maximum deviation of an NTC sensor in a 1 oz. vial located nearest the champer geometric center during a 24 hour test period

1058

Advanced Temperature Control & Durable Performance

• Intelligent microprocessor digital temperature controller • Adjustable operating control range from +2 to +8ºC • Digital display of the min/max temperature in Celsius or Fahrenheit • Password protected control parameters beyond setpoitn • Optimized forced air cooling for excellent stability & uniformity with rapid recovery • Open door and high/low temperature alarms • Factory installed lock conveniently located towards the top of each unit • ��

Pharma-Vac Refrigerators Accucold ARS1PV ARG1PV ARS3PV ARG3PV ARS6PV ARG6PV ARS8PV ARG8PV ARS12PV ARG12PV ARS15PV ARG15PV

Capacity 1 cu.ft. 1 cu.ft. 3 cu.ft. 3 cu.ft. 6 cu.ft. 6 cu.ft. 8 cu.ft. 8 cu.ft. 12 cu.ft. 12 cu.ft. 15 cu.ft. 15 cu.ft.

Height 21.5” 21.5” 33.75” 33.75” 32.5” 32.5” 50” 50” 61.75” 61.75” 72” 72”

Width 17.5” 17.5” 18.5” 18.5” 23.5” 23.5” 23.38” 23.38” 23.38” 23.38” 23.5” 23.5”

Depth 19.5” 20” 19” 19.5” 24.5” 25” 24.5” 25” 24.5” 25” 24.5” 25”

Door White Glass White Glass White Glass White Glass White Glass White Glass

790*, 936.00 949.00 1,059.50 1,072.50 1,180.40 1,193.40 1,497.60 1,510.60 2,002.00 2,015.00 2,294.50 2,307.50

Height 83.75 83.75 83.75 83.75

Width 27.5 27.5 55.25 55.25

Depth 31 31 31 31

Door (1) Stainless (1) Glass (2) Stainless (2) Glass

790*, 2,762.50 3,113.50 4,413.50 4,771.00

Height 83.75 83.75

Width 27.5 55.25

Depth 31 31

Door (1) Stainless (2) Stainless

790*, 3,178.50 5,063.50

Pharma-Lab Refrigerators Accucold ARS23ML ARG23ML ARS49ML ARG49ML

Capacity 23 cu.ft. 23 cu.ft. 49 cu.ft. 49 cu.ft.

Pharma-Lab Freezers Accucold AFS23ML AFS49ML

Capacity 23 cu.ft. 49 cu.ft.

Choosing the Right Sized Unit Below are a few handy steps for determining the ideal Accucold refrigerator size for your clinic:

Estimate the maximum number of doses of publicly-provided vaccine and privately purchased vaccine that will be in your refrigerator.

Refrigerator: Public Vaccine

Add the number of doses on hand (current inventory) from your last order form. ________________

Match your maximum doses with the minimum cubic feet needed to safely store your vaccine

Max. Doses

Minimum Cubic Ft.

2,000+ doses

may need more than one refrigerator

1000-2000

40 cu.ft 36 cu.ft 21-23 cu.ft

Private Vaccine

+ ________________

900-1000 801-900

Total doses

= ________________

701-800

17-19.5 cu.ft

Multiply (max inventory) Maximum doses

x 1.25 = ________________

400-700

11-16.7 cu.ft

100-399

4.9-6.1 cu.ft

PRODUCT FOCUS

CRYOSURGERY

CRYOLAB® MEDICAL From CryoConcepts 1059

CryoLab is a desk-top sized unit that delivers cryogen and employs pre-set spray times to ensure safe and effective treatment. Our lighted wand can spray the cryogen from any direction making it easier to treat all locations on the patient. CryoLab® can dispense nitrous oxide or carbon dioxide allowing physicians to treat cosmetically sensitive areas on the face, hands, and chest with less trauma and downtime.

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CRYOMEGA®

From CryoConcepts

This pen-like device is the perfect choice when low entry costs, portability, and precise delivery are critical to the practice. CryOmega® dispenses nitrous oxide – the coldest portable cryogen and the pinpoint tip allow physicians to effective treat the lesion site without harming healthy tissue. —

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CRYOCLEAR® 1061

From CryoConcepts This is a new pen-like cryo devices that dispenses carbon dioxide which is perfect for superficial lesions such as sun spots, age spots, and shin tags. CryoClear® has enough gas to treat between 20 and 30 lesions depending on the size and type.

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54 | PHYSICIANS OFFICE RESOURCE

GET BETTER OUTCOMES WITH CRYOSURGERY

NEW FOR

2021!

Your choice of a cryosurgical device has a big impact on patient outcomes. CryoConcepts has the broadest line of cryosurgical equipment in the world and our 28 years of experience is built into every single product.

1059 1062

BETTER DESIGN. BETTER OUTCOMES. BETTER FOR THE ENVIRONMENT. Our world class products include: CryOmega®, a portable pen-like device, CryoLab® Medical, a desktop-sized cryo unit, and Histofreezer® FLEX, our next generation canister that uses both cones and buds AND has the first returnable canister that is better for the environment.

MAR-115 (Rev 1)

Scan QR code for: ❆ A Virtual or In-Office Demo of any of our products

All Things

CRYO

❆ A FREE Lunch & Learn with our nationwide team of Cryo Experts

www.CryoConcepts.com

❆ A FREE E-book on better outcomes using cryosurgery in your practice

PRODUCT FOCUS

DIABETES

ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OF-CARE LIPID TESTING From Abbott

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1063

LAB-ACCURATE RESULTS FOR ACR AND HBA1C From Abbott

With its compact size and panel of tests, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital out-patient clinics. From just a small urine or fingerstick whole blood sample, lab-accurate results for ACR and HbA1c are made available during the consultation.

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1064

EXAM ROOM EQUIPMENT

1065

THE BREWER BASIC EXAM TABLE From Brewer

Full featured, entry-level exam table design. The Brewer Basic Exam Table features a pneumatic cylinder, seamless upholstery, and the largest storage capacity available. We invite you to compare features, price, warranty and you will find the Brewer Basic Exam Table is clearly the best entry level exam table available.

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56 | PHYSICIANS OFFICE RESOURCE

1066

BREWER’S ACCESS™ HIGH-LOW EXAM TABLE From Brewer

Design provides an 18” profile in the seated position to allow level transfer from standard wheelchair heights, complete with upright seat back and safety grab bars to simplify reliable patient transfers. The system also offers abundant storage capacity with Brewer’s signature pass-through drawer system and it is backed by Brewer’s standard 3-year warranty.

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BREWER’S FLEX™ ACCESS EXAM TABLE From Brewer

Step up to power table performance for less with Brewer’s Flex™ Access Exam Table. Industry-leading 700-lb. patient weight capacity, unique safety features and unmatched ergonomic patient access maximize your clinical efficiency and ROI. A streamlined footprint and optional upgrades like safety grab bars, stirrups, and pass-through work surface provide ultimate flexibility for your practice.

1067

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FLU AND RESPIRATORY

BD VERITOR™ PLUS SYSTEM From BD Veritor™

1068

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2022 · BUYERS GUIDE | 57

PRODUCT FOCUS

EXAM ROOM EQUIPMENT

PRODUCT FOCUS

FLU AND RESPIRATORY

BIOFIRE® FILMARRAY® TORCH From BioFire

The BioFire® FilmArray® Torch is a fully integrated, random, and continuous access system designed to meet your laboratory’s syndromic infectious disease testing needs. The BioFire Torch offers a radically reduced benchtop footprint, saving precious space in the lab, and its scalability meets high throughput demands. BioFire® FilmArray® Link Software automatically uploads patient results. Fully compatible with all CLIA Moderate BioFire® FilmArray® Panels, the BioFire Torch helps you maximize efficiency and productivity.

1069

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CLIA-WAIVED BIOFIRE® FILMARRAY® RESPIRATORY PANEL (RP) EZ From BioFire

View Brochures, Videos & More at POR.io Enter Number 1070 in the Search Area

1070

RELIABLE DETECTION OF STREP A, FLU A, FLU B AND RSV From Cepheid

Cepheid’s GeneXpert Xpress® brings standardized molecular testing to any healthcare setting. Employing the highly accurate and easy to use lab in a cartridge technology in every GeneXpert system, the GeneXpert Xpress® is a true on-demand walkaway testing system that provides accurate and reliable detection of Strep A, Flu A, Flu B and RSV. Two or four-module configurations save valuable bench space and reduce the need for multiple testing platforms.

1071

58 | PHYSICIANS OFFICE RESOURCE

View Brochures, Videos & More at POR.io Enter Number 1071 in the Search Area

1072

1073

1074

PRODUCT FOCUS

FLU AND RESPIRATORY

ACUCY INFLUENZA A&B TEST From Sekisui Diagnostics

1075

View Brochures, Videos & More at POR.io Enter Number 1075 in the Search Area

OSOM ULTRA PLUS FLU A&B TEST

From Sekisui Diagnostics

1076

View Brochures, Videos & More at POR.io Enter Number 1076 in the Search Area HEMATOLOGY ANALYZERS

TURN SMALL PLACES INTO SMART SPACES 1077

From Abbott

With reduced budgets, shrinking laboratory space and staffing challenges, many laboratories need a solution that lets them work smarter with less. The CELL-DYN Emerald 22 AL is a full performance, automated optical 5-part differential analyzer that delivers smarter results for small to midsize clinical laboratories. • Compact Design • Walkaway Functionality • Ease Of Use • Smart Safety Features

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60 | PHYSICIANS OFFICE RESOURCE

POINT OF CARE

1078

EHENS PR I M

TRANSFORM PATIENT SATISFACTION AND PRACTICE EFFICIENCY.

AVA I L A

CLIA Waived Tests: CMP, BMP, Lipid Panel, Lipid Panel Plus, General Chemistry, Kidney Check, Renal Panel, MetLyte 8 and Electrolytes

1079

Fast—Results in minutes, accelerating patient care decisions. Accurate—Lab-accurate results for a wide range of tests.* Versatile—Comprehensive CLIA-waived menu available. Simple—Intuitive function to improve operational efficiency. Convenient—Have test results during office visit, increasing patient satisfaction.

To learn more, contact your Abbott Point of Care representative at 888-893-0335, your distribution representative, or visit www.pointofcare.abbott *2016 Proficiency Testing Results, American Proficiency Institute, www.api-pt.com [Piccolo Xpress]. See cartridge information at www.pointofcare.abbott [i-STAT]. i-STAT Part No: 04J60-20 Waived Kit, 04J48-50 Moderately Complex Kit, 06F20-20 Waived Analyzer, 04P75-03 Moderately Complex Analyzer Piccolo Xpress Part No: 07P05-50 Piccolo Xpress with 3YR Serv, 07P05-51 Piccolo Xpress with 5YR Serv ©Abbott Point of Care Inc. 400 College Road East, Princeton, NJ 08540 www.pointofcare.abbott For in vitro diagnostic use only. This material is intended for a U.S. audience only. i-STAT is a trademark of Abbott. 3032.REV1 07/20 POR Ad - Abbott POC i-Stat/Piccolo Piccolo Xpress is a registered trademark of Abaxis, Inc. and distributed by Abbott Point of Care. Abaxis 888-3355 Rev A

PRODUCT FOCUS

HEMATOLOGY ANALYZERS

CELL-DYN EMERALD HEMATOLOGY ANALYZER From Abbott

CELL-DYN Emerald is a 3-part differential hematology analyzer that offers high performance in an affordable, compact design that provides reliable and accurate patient results every time. As a smaller operating laboratory, you need a solution that offers reliable results. CELL-DYN Emerald provides results in under 65 seconds. CELL-DYN Emereald’s small size, simple touch screen software and reliability offer an easy-to-use, truly compact table/bench top instrument for easy performance in your laboratory.

View Brochures, Videos & More at POR.io Enter Number 1080 in the Search Area

1080

MICROS HEMATOLOGY ANALYZER WITH 3-PART DIFFERENTIAL PLUS THE LITEDM From HORIBA Medical

Is it viral or bacterial? A CBC with 3-part differential can provide the clues to help distinguish between viral and bacterial infections before you decide to treat. The Micros 60 Hematology analyzer provides a CBC with 3-part Diff result in less than 60 seconds using only 10 µL of sample. Connect to the LiteDM Patient Data Management System for an affordable way to consolidate patient results to one report.

1081

View Brochures, Videos & More at POR.io Enter Number 1081 in the Search Area

PENTRA 60 C+ HEMATOLOGY ANALYZER WITH 5-PART DIFFERENTIAL From HORIBA Medical

Now you can have the same results hospitals and reference labs provide in a small, benchtop analyzer. The Pentra 60 C+ hematology analyzer provides a CBC with 5-part differential result using proprietary technology that ensures an accurate count and differential on the first run. Reduce repeats and reflex to the microscope with Pentra hematology technology.

1082

62 | PHYSICIANS OFFICE RESOURCE

View Brochures, Videos & More at POR.io Enter Number 1082 in the Search Area

FAST AND EASY. ACCURATE RESULTS EVERY TIME. CELL-DYN EMERALD Compact, easy-to-use 3-part differential hematology analyzer provides you with proven methods and technology, including electronic impedance, absorption spectrophotometry, electronic valves, cyanide-free lyse reagent, LCD color touch screen and USB ports. C O M PAC T D E S I G N Conserving valuable laboratory workspace with a small footprint and only 2 reagents plus on-board cleaner.

EASE OF USE • Decreasing manual entry errors and increasing compliance by use of barcoded reagents • Reducing hands-on time with touch-free scheduled daily maintenance, startup and shutdown

F L E X I B L E U S E R I N T E R FAC E • Improving use and easing training of software functions with color touch screen and numeric keypad • Providing positive patient identification with barcode reader for specimens

RELIABILIT Y Helping you keep your commitments

O P T I C A L 3-PA R T D I F F E R E N T I A L Delivering comprehensive results for your doctors and patients

Learn how the CELL-DYN Emerald 22 can help your laboratory operate more efficiently at:

COREL ABORATORY.ABBOT T/HEMATOLOGY

1080

For in vitro diagnostic only. Refer to the Operator’s Manual for operational precautions, limitations, and hazards. ADD-00074091 12/20.

PRODUCT FOCUS

HEMATOLOGY ANALYZERS

MICROS ES 60 HEMATOLOGY ANALYZER WITH 3-PART DIFFERENTIAL From HORIBA Medical

1083

Simple to use and easy to maintain with a zero maintenance concept, the Micros ES 60 is a small tabletop hematology analyzer with an integrated data management system. The analyzer provides a CBC with 3-part differential result in less than 60 seconds using only 10 µL of sample. Connect to the LiteDM Patient Data Management System for an affordable way to consolidate patient results to one report.

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PENTRA XLR HEMATOLOGY ANALYZER WITH 5-PART DIFFERENTIAL From HORIBA Medical

The Pentra XLR hematology analyzer with autoloader provides a CBC with 5-part Diff result using proprietary technology that ensures an accurate count and differential on the first run. The Pentra XLR also provides a complete menu of Retic parameters for treating oncology and anemia patients. The autoloader processes 80 samples an hour and provides random continuous access for medium-to high-volume clinics and rural or community hospitals.

View Brochures, Videos & More at POR.io Enter Number 1084 in the Search Area

1084

FIRST EVER CLIA WAIVED HEMATOLOGY ANALYZER From Sysmex 1085

View Brochures, Videos & Mores at POR.io Enter Number 1085 in the Search Area 64 | PHYSICIANS OFFICE RESOURCE

1086

PRODUCT FOCUS

HEMATOLOGY ANALYZERS

HEMATOLOGY TESTING MADE EASY From Sysmex

Designed for labs testing up to 25 samples per day, the Sysmex pocH-100i™ has the smallest footprint of any analyzer on the market. The instrument requires only 15uL of whole blood for reporting of 17 clinical parameters, including a 3-part WBC Differential. It is ideal for urgent care, physician office lab, small clinic, or any outpatient setting where a point of care CBC is needed.

View Brochures, Videos & More at POR.io Enter Number 1087 in the Search Area

1087

NOW IT’S MORE THANK JUST A BLOOD TEST From Sysmex

With its simplified operation, the Sysmex XP-300™ is ideal for clinics and physician office labs. It provides a CBC with 17 different parameters, including a 3-part WBC Differential. The XP300+M combines the accuracy and reliability of a Sysmex CBC with the agility of Medicus Middleware. Features include EMR connectivity, instrument interfaces and a QC module.

View Brochures, Videos & More at POR.io Enter Number 1088 in the Search Area

1088

IMMUNOASSAY ANALYZERS

THE NANOENTEK FREND IMMUNOASSAY SYSTEM 1089

From NanoEnTek

The NanoEnTek FREND Immunoassay System provides Vitamin D, TSH, fT4, PSA, and Testosterone results in minutes with a no cost placement program. Complete all 5 tests in less than 20 minutes for same visit patient consultation. PSA and TSH results are available in 3 minutes or less. Imagine having a new source of revenue with improved practice efficiency and patient satisfaction. Thoughtfully designed, with your practice in mind.

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66 | PHYSICIANS OFFICE RESOURCE

FULLY AUTOMATED QUANTITIVE IMMUNOASSAY ANALYZER From Sekisui Diagnostics

The FastPack® IP System is a fully automated quantitative immunoassay analyzer designed for use in the Physician Office laboratory. Utilizing sophisticated chemiluminescence technology, the FastPack® IP System provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button. Menu includes Vitamin D, Testosterone, TSH, Free T4 PSA and hCG.

View Brochures, Videos & More at POR.io Enter Number 1090 in the Search Area

1090 LABORATORY SERVICES

MEDICUS LIS

1091

From Medicus LIS If you are considering in-house lab testing, including Covid-19 testing and required reporting to state agencies, connecting Lab to LIS and EHR makes the process of test orders to completed results much easier. Providers receive test results posted to patient charts in real-time, expediting patient care, saving time, money and even preparing for lab test reimbursement goals. Link Your Lab with Medicus LIS today! Contact us: 888-643-8081 sales@medicuslis.com

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MAKE LABORATORY COMPLIANCE AND INSPECTION EASIER From My Inspection

1092

Make laboratory compliance and inspections easier by changing how you document, save and retrieve all information necessary to meet CLIA and accreditation regulations. With two unique electronic tools My Compliance Manual and MyInspection™ Software, the guesswork and tedious task of interpreting and documenting policy, procedure, forms, charts and logs is over. Your lab will be compliant, have less paper, and be inspection ready.

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2022 · BUYERS GUIDE | 67

PRODUCT FOCUS

IMMUNOASSAY ANALYZERS

PRODUCT FOCUS

SPIROMETRY

MICRO 1 SPIROMETER From MicroDirect

Specifically designed for situations where low cost precision spirometry measurements are required, the Micro I Spirometer measures the following parameters FEV1, FVC, PEF, FEF25-75, EEV6, FEV1/FVC, FEV1/FEV6, FEF25 and FEF25 that cn be displayed along with percent predicted and post bronchodilator comparisons and provide an optional printout if needed. Extremely lightweight and portable making it suitable for hospital outreach clinics, bedside screenings, health fair screenings and other situations where remote testing is required.

1093

View Brochures, Videos & More at POR.io Enter Number 1093 in the Search Area

SPIROMETRY IS EASY

From MicroDirect

Unless the equipment is easy to use, it will not be fully utilized by your staff. The MicroLab and MicroLoop are menu driven via a large graphic display and the test takes less than five minutes to perform. The easy-to-read reports, quality checks and built-in interpretation assist with your diagnosis. Your office sees patients with indications for spirometry on a daily basis. Accurately and quickly diagnosis them so you can properly treat them.

View Brochures, Videos & More at POR.io Enter Number 1094 in the Search Area

1094

PORTABLE, SINGLE CLICK OPERATION SPIROMETER From MicroDirect 1095

The MicroDirect SpiroUSB many features include single click operation of all main functions, full ATS/ERS test quality checks, real time Flow/Volume and Volume/ Time traces, a choice of child incentive displays, choice of predicted values, estimated lung age, pre/post bronchodilator comparisons and can be used on multiple PC’s with dongle software protection key. The child incentive display and ATS quality checks ensure maximal results every time. Use with a laptop for true portability.

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68 | PHYSICIANS OFFICE RESOURCE

BD VERITOR™ PLUS SYSTEM From BD Veritor™ 1096

View Brochures, Videos & More at POR.io Enter Number 1096 in the Search Area

RELIABLE DETECTION OF STREP A, FLU A, FLU B AND RSV From Cepheid

View Brochures, Videos & More at POR.io Enter Number 1097 in the Search Area

1098

1097

OSOM® ULTRA STREP A TEST From Sekisui Diagnostics

View Brochures, Videos & More at POR.io Enter Number 1098 in the Search Area

2022 · BUYERS GUIDE | 69

PRODUCT FOCUS

STREP TEST

PRODUCT FOCUS

TOXICOLOGY

TOXICOLOGY SCREENING SIMPLIFIED ABBOTT’S IMMTOX 270 BENCHTOP ANALYZER NOW WITH 14 ASSAYS CLIA CATEGORIZED AS MODERATE COMPLEXITY From Abbott

1099

View Brochures, Videos & More at POR.io Enter Number 1099 in the Search Area

TOXICOLOGY URINE DRUG SCREENING REAGENTS From Abbott

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1100 URINALYSIS

LAB-ACCURATE RESULTS FOR ACR AND HBA1C From Abbott

With its compact size and panel of tests, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital out-patient clinics. From just a small urine or fingerstick whole blood sample, lab-accurate results for ACR and HbA1c are made available during the consultation.

1101

70 | PHYSICIANS OFFICE RESOURCE

View Brochures, Videos & More at POR.io Enter Number 1101 in the Search Area

GAVRETO®—the only once-daily targeted RET therapy for patients with RET+ metastatic NSCLC and advanced thyroid cancers.1 NSCLC=non–small cell lung cancer; RET=rearranged during transfection.

Learn more at GAVRETO-hcp.com INDICATIONS GAVRETO® (pralsetinib) is indicated for the treatment of: • Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION Interstitial Lung Disease (ILD)/Pneumonitis occurred in 10% of patients who received GAVRETO, including 2.7% with Grade 3/4, and 0.5% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD. Hypertension occurred in 29% of patients, including Grade 3 hypertension in 14% of patients. Overall, 7% had their dose interrupted and 3.2% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity. Hepatotoxicity: Serious hepatic adverse reactions occurred in 2.1% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 69% of patients, including Grade 3/4 in 5% and increased alanine aminotransferase (ALT) occurred in 46% of patients, including Grade 3/4 in 6%. The median time to first onset for increased AST was 15 days (range: 5 days to 1.5 years) and increased ALT was 22 days (range: 7 days to 1.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity. Grade ≥ 3 hemorrhagic events occurred in 2.5% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage. Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated. Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established. Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the final dose. Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the final dose. Common adverse reactions (≥25%) were constipation, hypertension, fatigue, musculoskeletal pain and diarrhea. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased calcium (corrected), decreased sodium, increased AST, increased ALT, decreased platelets and increased alkaline phosphatase. Avoid coadministration of GAVRETO with strong CYP3A inhibitors or combined P-gp and strong CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555. Please see Brief Summary of full Prescribing Information for GAVRETO on adjacent pages. Reference: 1. GAVRETO Prescribing Information. Genentech, Inc. April 2021.

GAVRETO, Blueprint Medicines, and associated logos are trademarks of Blueprint Medicines Corporation. The Genentech logo is a registered trademark of Genentech, Inc. © 2021 Blueprint Medicines Corporation and Genentech, Inc. All rights reserved. M-US-00011244(v1.0)

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OSOM®®®Ultra Flu A&B Test OSOM OSOM Ultra UltraFlu FluA&B A&BTest Test ® OSOM Ultra Flu A&B Test • Cartridge, Visual read •• Cartridge, Cartridge,Visual Visualread read ••Good Performance* Cartridge, Visual read •• Good GoodPerformance* Performance* ••QC inside Good Performance* •• QC QCinside inside • QC inside

OSOM®® Ultra Plus Flu A&B Test ® OSOM Plus FluFlu A&B TestTest OSOMUltra Ultra Plus A&B ® OSOM Ultra Plus Flu A&B Test • Dipstick, Visual read •• Dipstick, Visual read Dipstick, Visual read ••High Performance* Dipstick, Visual read •• High Performance* High Performance* ••QC Highinside Performance* •• QC inside QC inside • QC inside

Acucy®® Inflluenza A&B Test ® Acucy Inflluenza A&BA&B Test Test Acucy Inflluenza ® Acucy Inflluenza A&B Test • Digital Reader • Digital Reader • Digital Reader

••Best In Class Flu A Performance* Digital Reader • Best In Class Flu AFlu Performance* • Best In Class A Performance* ••Best Bestvalue* In Class Flu A Performance* • Best value* • Best value* ••QC Bestinside value* • QC inside • QC inside • QC inside

1104

1102

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For more information call 888-616-0537, Option 2 or visit us online at flutesting.com

*When compared to immunoassay products in market (refer to manufacturer instructions for use). © 2021 SEKISUI Diagnostics, LLC. ® ® *When compared immunoassay products in markettrademarks (refer to manufacturer instructionsLLC. for use). © 2021 SEKISUI Because every resultDiagnostics, matters™ LLC. All rights reserved. to and Acucy OSOM of SEKISUI Diagnostics, are registered

® ® every result matters™ All reserved. and Acucy OSOM of SEKISUI Diagnostics, LLC. are registered trademarks is arights trademarks of SEKISUI Diagnostics, LLC. *When compared to products toto manufacturer instructions for Because use). © 2021 SEKISUI Diagnostics, LLC. LLC. *When compared to immunoassay immunoassay productsininmarket market(refer (refer manufacturer instructions for use). © 2021 SEKISUI Diagnostics, ® isAll a trademarks of SEKISUI Diagnostics, LLC. ® ® and Acucy ®are registered trademarks of SEKISUI Diagnostics, LLC. Because every result matters™ rights reserved. OSOM All rights reserved. OSOM and Acucy are registered trademarks of SEKISUI Diagnostics, LLC. Because every result matters™ trademarks of SEKISUI Diagnostics, LLC. isisaatrademarks of SEKISUI Diagnostics, LLC.

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