Resources for You, Your Patients, & Your Practice
2024 BUYERS GUIDE
THE POWER TO DETECT THE HIDDEN THREAT OF PERIPHERAL ARTERIAL DISEASE (PAD)
3400
“PAD IS ASYMPTOMATIC IN 75% OF ELDERLY PATIENTS.” 1
IN PRIMARY CARE: “THE RISK OF MORTALITY WAS SIMILAR IN SYMPTOMATIC AND ASYMPTOMATIC PATIENTS WITH PAD” 2
BOOK YOUR FREE DEMO CONTACT US TODAY AT 888-340-4881, 5 OR INFO@SEMLERSCIENTIFIC.COM
SEMLERSCIENTIFIC.COM
1. Sillesen, H., & Falk, E. (2011). Peripheral artery disease (PAD) screening in the asymptomatic population: why, how, and who?. Current atherosclerosis reports, 13(5), 390–395. https://doi.org/10.1007/s11883-011-0196-x 2. Diehm, C., Allenberg, J. R., Pittrow, D., Mahn, M., Tepohl, G., Haberl, R. L., Darius, H., Burghaus, I., Trampisch, H. J., & German Epidemiological Trial on Ankle Brachial Index Study Group (2009). Mortality and vascular morbidity in older adults with asymptomatic versus symptomatic peripheral artery disease. Circulation, 120(21), 2053–2061. https://doi.org/10.1161/CIRCULATIONAHA.109.865600 ML00190 Rev A
PUBLISHED BY Medical Education Resources, LLC PUBLISHER Aaron R. Medaris amedaris@physiciansofficeresource.com
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TRAVEL EDITOR Brandi L. Brower EDITORIAL BOARD Michael Paquin, FHIMSS Barry Craig, MLT (NCA), CLC STAFF WRITER Dylan J. Chadwick
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2024 BUYERS GUIDE | 3
2024 BUYERS GUIDE
WHAT’S IN THIS GUIDE
12 —
17 —
23 —
2023 Medical Conferences
Diagnostics and Device Company Directory
Health Agency Hotlines
26 —
28 —
State Medical Associations
Companies by Categories
25 —
Government Organizations
45 —
PRODUCT GUIDE
POC-22-NAM-3308
Meet the Quadruple Aim in Diabetes Care with In-office HbA1c and uACR Better outcomes. Lower costs. Better patient experience. Better clinician experience.
Comprehensive diabetes-management solutions at the point-of-care Gain key insights into your patient’s current status and drive guideline recommended test adherence: DCA Vantage® Analyzer CLIA-waived HbA1c • Rapid assessment for glycemic control CLINITEK Status® Connect System CLIA-waived analyzer for routine urinalysis • Rapid kidney health assessment: CLINITEK® Microalbumin 2 Strip Albumin-to-creatinine ratio (ACR) Total U.S. Population with Diabetes
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54,913,000 43,271,000 35,644,000
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2030 Projected
1. Rowley, William R et al. “Diabetes 2030: Insights from Yesterday, Today, and Future Trends.” Population health management vol. 20,1 (2017): 6-12. doi:10.1089/pop.2015.0181.
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| 2024 |
MEDICAL CONFERENCES
JANUARY American Association for Hand Surgery 2024 Annual Meeting January 9 – 13, 2024 Nassau, Bahamas 978-927-8330 www.handsurgery.org American Society for Reconstructive Microsurgery Annual Meeting 2024 January 12 – 16, 2024 Miami Nassau, Bahamas 312-456-9579 www.microsurg.org CANS Annual Meeting 2024 California Association of Neurological Surgeons January 12 - 14, 2024 San Francisco, CA 916-457-2267 www.cans1.org SCCM Critical Care Congress Society of Critical Care Medicine January 21 – 23, 2024 Phoenix, AZ 847-827-6888 www.sccm.org
STS Annual Meeting Society of Thoracic Surgeons January 27 – 29, 2024 San Antonio, TX 312-202-5800 www.sts.org
AAOS Annual Meeting 2024 American Academy of Orthopaedic Surgeons February 12 –16, 2024 San Francisco, CA 847-823-7186 www.aaos.org
AAD Annual Meeting 2024 American Academy of Dermatology March 8 – 12, 2024 San Diego, CA 866-503-7546 www.aad.org/meetings/ annual-meeting
ORS 2024 Annual Meeting Orthopaedic Research Society February 2 – 6, 2024 Long Beach, CA 847-823-5770 www.ors.org
2024 AAAAI Annual Meeting American Academy of Allergy Asthma & Immunology February 23 – 26, 2024 Washington, DC 414-272-6071 www.annualmeeting. aaaai.org
AORN Global Surgical Conference & Expo 2024 Association of Perioperative Registered Nurses March 9 – 12, 2024 Nashville, TN 800-755-2676 www.aorn.org
Pri-Med South February 8 – 10, 2024 Ft. Lauderdale, FL 877-477-4633 www.pri-med.com
MARCH
AAPM Annual Meeting American Academy of Pain Medicine March 10 – 7, 2024 Scottsdale, AZ 847-375-4731 www.aapmannualmeeting.com
FEBRUARY
Biophysical Society Annual Meeting 2024 Biophysical Society February 10 – 14, 2024 Philadelphia, PA 240-290-5600 www.biophysics.org/ 2024meeting#/
12 | PHYSICIANS OFFICE RESOURCE
The Aesthetic Meeting 2024 The American Society for Aesthetic Plastic Surgery May 2 – 5, 2024 Vancouver, BC 800-364-2147 www.surgery.org
2024 Annual HIMSS Conference & Exhibition Healthcare Information and Management Systems March 11 – 15, 2024 Orlando, FL 855-326-8342 www.himssconference. org
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2023 MEDICAL CONFERENCES
SGO 2024 Annual Meeting on Women’s Cancer Society of Gynecologic Oncologists March 16 – 18, 2024 San Diego, CA 312-235-4060 www.sgo.org SSO 2024 Annual Cancer Symposium Society of Surgical Oncology March 20 – 23, 2024 Atlanta, GA 847-427-1400 www.surgonc.org
SIR 2024 Annual Scientific Meeting Society of Interventional Radiology March 23 – 28, 2024 Salt Lake City, UT 800-488-7284 www.SIRmeeting.org
APRIL AACR Annual Meeting 2024 American Association of Cancer Research April 5 – 10, 2024 San Diego, CA 866-423-3965 www.aacr.org AAC 2024 Annual Scientific Session and Expo American College of Cardiology April 6 – 8, 2024 Atlanta, GA 800-253-4636 https://accscientificsession.acc.org
AMGA Annual Conference 2024 American Medical Group Association April 9 – 12, 2024 Orlando, FL 703-838-0033 www.amga.org ASBS Annual Meeting 2024 American Society of Breast Surgeons April 10 – 14, 2024 Orlando, FL 877-992-5470 www.breastsurgeons.org ASLMS 2024 Annual Conference American Society for Laser Medicine & Surgery April 11 – 14, 2024 Baltimore, MD 877-258-6028 www.aslms.org Pri-Med Southwest 2024 April 11 – 13, 2024 Houston, TX 877-774-6338 www.pri-med.com ACR Annual Meeting 2024 American College of Radiology April 13 – 17, 2024 Washington, DC 800-243-7419 www.acr.org/annual-meeting ARRS Annual Meeting 2024 American Roentgen Ray Society April 13 – 18, 2024 Denver, CO 866-940-2777 www.arrs.org
14 | PHYSICIANS OFFICE RESOURCE
SAGES 2024 Annual Meeting Society of American Gastrointestinal Endoscopic Surgeons April 17 – 20, 2024 Cleveland, OH 310-437-0544 www.sages2024.surgery ACP Internal Medicine Meeting 2024 American College of Physicians April 18 – 20, 2024 Boston, MA 800-523-1546 https://annualmeeting. acponline.org/ AAN Annual Meeting 2024 American Academy of Neurology April 22 – 27, 2024 Boston, MA 800-879-1960 www.aan.com AATS Annual Meeting 2024 American Association for Thoracic Surgery April 27 – 30, 2024 Toronto, ON 978-927-8330 www.aats.org
MAY AANS Annual Scientific Meeting 2024 American Association of Neurological Surgeons May 3 – 6, 2024 Chicago, CA 847-378-0500 www.aans.org
AACE 2024 Annual Scientific & Clinical Congress American Association of Clinical Endocrinologists May 9 – 11, 2024 New Orleans, LA 904-353-7878 www.aace.com AANA Annual Congress 2024 Arthroscopy Association of North America May 9 – 11 2024 Boston, MA 847-292-2262 www.aana.org ACOG 2024 Annual Clinical and Scientific Meeting American College of Obstetricians and Gynecologists May 17 – 19, 2024 San Francisco, CA 800- 673-8444 www.acog.org
ATS 2024 International Conference American Thoracic Society May 17 – 22, 2024 San Diego, CA 212-315-8600 conference.thoracic.org ASNR Annual Meeting & The Foundation of the ASNR Symposium 2024 American Society of Neuroradiology May 18 – 22, 2024 Las Vegas, NV 630-574-0220 www.asnr.org
2023 MEDICAL CONFERENCES
ACSM Annual Meeting American College of Sports Medicine May 28 – 21, 2024 Boston, MA 317-637-9200 www.acsm.org/annual-meeting/annual-home
JUNE APIC Annual Conference 2024 Association for Professional in Infection Control and Epidemiology June 3 – 5, 2024 San Antonio, TX 202-789-1890 annual.apic.org BIO International Convention 2024 Biotechnology Industry Organization June 3 – 6, 2024 San Diego, CA 202-962-6655 bio.org/ SNMMI 2024 Annual Meeting Society of Nuclear Medicine & Molecular Imaging June 8 – 10, 2024 Toronto, ON 703-708-9000 www.snmmi.org AMA Annual Meeting of House of Delegates 2024 American Medical Association June 8 – 12, 2024 Chicago, Illinois 800-621-8335 www.ama-assn.org
ENDO Annual Meeting 2024 The Endocrine Society June 11 – 14, 2024 Atlanta, GA 888-363-6274 www.endocrine.org
JULY Pri-Med West 2024 July 18 – 20, 2024 Anaheim, CA 877-774-6338 www.pri-med.com AAPM Annual Meeting 2024 American Association of Physicists in Medicine July 21 – 25, 2024 Los Angeles, CA 571-298-1300 www.aapm.org ADLM 2024 Annual Meeting & Clinical Lab Expo (Formerly AACC) Association for Diagnostics & Laboratory Medicine July 28 – August 1, 2024 Chicago, IL 800-892-1400 www.aacc.org
SEPTEMBER
OCTOBER
FMX 2024 American Academy of Family Physicians September 24 – 28, 2024 Phoenix, AZ 800-274-2237 www.aafp.org
CHEST 2024 ACCP Annual Meeting American College of Chest Physicians October 6 –9, 2024 Boston, MA 800-343-2227 www.chestnet.org
NASS 2024 Annual Meeting North American Spine Society September 25 – 28, 2024 Chicago, IL 630-230-3600 www.spine.org
ISPE Annual Meeting 2024 International Society for Pharmaceutical Engineering October 13 – 16, 2024 Orlando, FL 301-364-9201 www.ispe.org
CNS Annual Meeting 2024 Congress of Neurological Surgeons September 28 – October 2, 2024 Houston, TX 847-240-2500 www.cns.org
AAO Annual Meeting 2024 American Academy of Ophthalmology October 18 – 21, 2024 Chicago, IL 415-561-8500 www.aao.org
ACEP Annual Scientific Assembly 2024 American College of Emergency Physicians September 29 – October 2, 2024 Las Vegas, NV 800-798-1822 www.acep.org
AUGUST PDA Annual Meeting Pacific Dermatologic Association August 22 – 25, 2024 Huntington Beach, CA 888-388-8815 www.pacificderm.org
ASTRO Annual Meeting 2024 American Society for Therapeutic Radiology & Oncology September 29 – October 2, 2024 Washington, DC 703-502-1550 www.astro.org
The ANESTHESIOLOGY 2024 Annual Meeting American Society of Anesthesiologists October 18 – 22, 2024 Philadelphia, PA 847-825-5586 www.asahq.org ASRM Scientific Congress and Expo 2024 American Society for Reproductive Medicine October 19 – 23, 2024 Denver, CO 205-978-5000 www.asrm.org
2024 BUYERS GUIDE | 15
ACAAI 2024 Annual Meeting American College of Allergy Asthma & Immunology October 24 – 28, 2024 Boston, MA 847-427-1200 www.acaai.org
NOVEMBER
DECEMBER RSNA 2024 Scientific Assembly and Annual Meeting Radiological Society of North America December 1 – 5, 2024 Chicago, IL 800-381-6660 www.rsna.org
ASHG 2024 American Society of Human Genetics November 5 – 9, 2024 Denver, CO 301-634-7300 www.ashg.org
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16 | PHYSICIANS OFFICE RESOURCE
New iPad EKG
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DIAGNOSTIC + DEVICE COMPANY
DIRECTORY A
Abbott Hematology Division 4551 Great America Parkway Santa Clara CA 95054 408-982-4850 www.corelaboratory. abbott/int/en/offerings/ category/hematology Abbott Point of Care 400 College Road East Princeton, NJ 08540 800-827-7828 www.globalpointofcare. abbott/en/index.html Abbott Toxicology 829 Towne Center Dr. Pomona, CA 91767 888-831-6850 https://www.aleretoxicology.com/home.html Aerolase 120 White Plains Rd Tarrytown, NY 10591 914-345-8300 www.aerolase.com ALCOR Scientific Inc. 20 Thurber Blvd Smithfield, RI 02917 800-495-5270 www.alcorscientific.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
B
American Academy of Family Physicians 11400 Tomahawk Creek Parkway Leawood, KS 66211-2672 800-274-2237 www.aafp.org
Beckman Coulter 5350 Lakeview Pkwy S Drive Indianapolis, IN 46268 800-526-3821 www.beckmancoulter. com
American Screening Corporation 9742 St Vincent Ave. Ste 100 Shreveport, LA 71106 866-526-2873 www.americanscreeningcorp.com
Bone Index Finland Ltd. 3710 Rawlins St., Suite 1420 Dallas, TX 75219 469-805-5419 www.bindex.us
AMS Alliance 1790 N. Commerce Pkwy Weston, FL 33326 1 (954) 217-0040 www.kpmanalytics.com/ brands/ams-alliance Apyx Medical 5115 Ulmerton Road Clearwater, FL 33760 800-537-2790 www.apyxmedical.com Arkray 5198 W. 76th Street Edina, MN 55439 800-818-8877 www.arkrayusa.com
BD 7 Loveton Circle Sparks, MD 21152 1-800-638-8663 www.bd.com
bioMerieux 1201 S 4800 W Salt Lake City, UT 84104 www.biofiredx.com Bio-Rad Laboratories 1000 Alfred Nobel Drive Hercules, CA 94547 800-424-6723 www.bio-rad.com Bionix Development Corporation 1670 Indian Wood Circle Maumee, OH 43537 800-551-7096 www.bionix.com The Brewer Company N88 W13901 Main Street, Suite 100 Menomonee Falls, WI 53051 888-273-9371 www.brewercompany. com
Brymill Cryogenic Systems 105 Windermere Avenue Ellington, CT 06029 860-875-2460 www.brymill.com
C Candela 3 Goodyear, Unit A Irvine, CA 92618 800-733-8550 www.candelamedical. com Carolina Liquid Chemistries 313 Gallimore Dairy Rd Greensboro, NC 27409 877-722-8910 www.carolinachemistries.com Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 888-336-2743 www.cepheid.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 561-288-9028 www.claritydiagnostics. com
2024 BUYERS GUIDE | 17
DIAGNOSTIC + DEVICE COMPANY DIRECTORY Clinical Diagnostics Solutions, Inc. 1800 NW 65th Avenue Plantation, FL 33313 954-791-1773 www.cdsolinc.com Co-Diagnostics, Inc. 3222 S Washington St. South Salt Lake, UT 84115 www.co-dx.com 801-438-1036 COLA 9881 Broken Land Parkway Suite 200 Columbia, MD 210463016 800-981-9883 www.cola.org Cooper Surgical 75 Corporate Dr. Trumbull, CT 06611 800-243-2463 www.coopersurgical. com CryoConcepts, LP 1100 Conroy Place Easton, PA 18040 855-355-2796 Cryoconcepts.com Cutera, Inc. 3240 Bayshore Boulevard Brisbane, CA 94005 415-657-5500 www.cutera.com
D The Daavlin Company 205 West Bement Street Bryan, OH 43506 419-636-6304 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
E ELITechGroup North America 370 West 1700 South Logan, UT 84321 800-354-8324 www.elitechgroup.com Erba Mannheim DSP Tower – South, 19th Floor Dubai Science Park Dubai, UAE www.erbamannheim. com Evoke Neuroscience 1115 Broadway, 12th FL. New York, NY 10010 917-261-6096 www.evokeneuroscience.com Exergen Corporation 400 Pleasant St. Watertown, MA 02472 1-800-422-3006 www.exergen.com
F
18 | PHYSICIANS OFFICE RESOURCE
FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 980213904 877-657-8118 www.sonosite.com Futuremed 15700 Devonshire Street Granada Hills, CA 91344 800-222-6780 www.futuremed.com
G Greenway Health, LLC. 4301 W Boy Scout Blvd, Suite 800 Tampa, FL 33607 877.932.6301 www.greenwayhealth. com
H H&O Equipments Inc. 115 Fairchild St. Suite 370 Charleston, SC 29492 888-248-2838 www.ho-equipments. com Heine North America 10 Innovation Way Dover, NH 03820 603-742-7103 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 626-443-8255 www.hemosure.com Hill-Rom 130 E Randolph St. Suite 1000 Chicago, IL 60601 312-819-7200 www.hillrom.com Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 508-263-2900 www.hologic.com Horiba Medical 9755 Research Dr. Irvine, CA 92618 800- 446-7422 www.horiba.com/usa/ medical Huntleigh Diagnostics 35 Portmanmoor Road Cardiff CF24 5HN Wales UK 800-323-1245 www.huntleigh-diagnostics.com
I Interson Corporation 7150 Koll Center Parkway Pleasanton, CA 94566 925-462-4948 www.interson.com iSalus Healthcare 1 Virginia Avenue Suite 500 Indianapolis, IN 46204 888-280-6678 www.isalushealthcare. com
J Jant Pharmacal 16530 Ventura Blvd.,
is an often silent condition where narrowed P E R I P H E R A L (PAD) arteries reduce blood flow to the legs, causing symptoms ARTERY DISEASE like leg pain, numbness, and slow-healing wounds.
HOW MANY OF THESE PATIENTS DO YOU HAVE? Diabetics
Smokers
Over age 65
1 out of 3 HAS PAD
DON’T LET PAD SNEAK UP ON YOU OR THESE PATIENTS. 50% report no symptoms, while those that do attribute their pain to arthritis or “old age”.
Atherosclerosis
THESE PATIENTS TRUST YOU TO FIND THEIR PAD before they have a heart attack, stroke, or even die. PAD also leads to significant disability and reduced quality of life.
INTRODUCING SIMPLEABI-Q: A USER-FRIENDLY SOLUTION FOR EARLY PAD TESTING. EASY No Doppler or vascular anatomy knowledge necessary. Can be done in five minutes or less by any staff member. Non-invasive, patient-friendly test. ACCURATE 3405 Accuracy equal or better than Doppler ABI. Useful for diabetics with calcified arteries. REIMBURSABLE Great ROI: the typical internist has 800 Medicare patients, per ACP. Testing five patients per week can pay for the system in less than two months. CPT 93923, with a national average of $142/exam.
With over 40 years of experience in diagnostic ultrasound, Newman Medical is a trusted leader in vascular testing solutions. Newman's ABI-Q rapid-test system epitomizes their commitment to pioneering technology. Built on integrity and expertise, count on Newman Medical for precise, rapid, and reliable vascular testing solutions.
CONTACT US NOW
Book a free live demo of the simpleABI-Q:
to learn how early PAD detection benefits both your patients and your practice.
NEWMAN-MEDICAL.COM | 800-267-5549 | INFO@NEWMAN-MEDICAL.COM
DIAGNOSTIC + DEVICE COMPANY DIRECTORY Suite 512 Encino, CA 91436 800-676-5565 www.jantdx.com Jones Medical Instrument Company 200 Windsor Drive Oak Brook, IL 60523 800-323-7336 www.jonesmedical.com
K Korr Medical Technologies, Inc. 3487 W 2100 S, Building 300 Salt Lake City, UT 84119 877-895-3007 www.korr.com
L LifeSign 85 Orchard Road Skillman, NJ 08558 800-526-2125 www.lifesignmed.com
M Masimo 52 Discovery Irvine, CA 92618 949-297-7000 www.masimo.com Medica Corporation 5 Oak Park Drive Bedford, MA 01730 800-777-5983 www.medicacorp.com Medical Device Depot 3230 Bethany Lane, Suite 8 Ellicott City, MD 21042 877-646-3300 www.medicaldevicedepot.com
Meridian Bioscience 3471 River Hills Drive Cincinnati, OH 45244 800-696-0739
www.meridianbioscience.com MIR - Medical International Research 5462 S. Westridge Drive New Berlin, WI 53151 262-565-6797 www.spirometry.com 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 Mercedes Scientific 12210 Rangeland Parkway Lakewood Ranch, FL 34211 800-331-2716 www.mercedesscientific. com Micro Direct 803 Webster St. Lewiston, ME 04240 800-588-3381 www.mdspiro.com Midmark 60 Vista Dr Versailles, OH 45380 937-526-3662 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
20 | PHYSICIANS OFFICE RESOURCE
800-675-1202 www.morningsidemedicalequipment.com My Inspection 4555 NW 103rd Avenue Suite 105 Sunrise, FL 33351 888-643-8081 www.myinspection.us
N 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 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
O Opti Medical Systems, 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/
P pts Diagnostics 7736 Zionsville Road Indianapolis, IN 46268 877-870-5610 www.ptsdiagnostics. com Phreesia 434 Fayetteville St. #1400 Raleigh, NC 27601
TO X I C O LO G Y S C R E E N I N G
SIMPLIFIED. Comprehensive toxicology menu now with 14 CLIA1 categorized moderate complexity assays.
3406
IMMTOX™ 270
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MODERATE COMPLEXIT Y ASSAYS – FDA 510(K) CLEARED 6-acetylmorphine (6-AM Heroin metabolite)
EDDP (Methadone metabolite)
Amphetamine
Fentanyl*
Barbiturates
Methamphetamine
Benzodiazepines
Opiates
Benzoylecgonine (Cocaine metabolite)
Oxycodone
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Tramadol
CONTACT ABBOTT CLINICAL LAB SOLUTIONS
855-425-9428 | CLS_SALES@ABBOTT.COM 1. Clinical Laboratory Improvement Amendments (CLIA) / * SEFRIA Fentanyl
© 2022 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. COL-09575 v3 12/22
DIAGNOSTIC + DEVICE COMPANY DIRECTORY 888-654-7473 www.phreesia.com Physicians Office Resource A Division of Medical Education Resources, LLC 125 High Meadow Rd Newbury, NH 03255 603-417-7305 www.physiciansofficeresource.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 888-773-6872 www.premiermedicalco. com
Q Quest Diagnostics 500 Plaza Drive Secaucus, NJ 07094 973-520-2700 www.questdiagnostics. com QuidelOrtho 9975 Summers Ridge Rd. San Diego, CA 92121 858.552.1100 www.quidelortho.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 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 https://diagnostics. roche.com Schiller America, Inc. 10903 NW 33rd St. Doral, FL 33172 786-845-0620 www.schillerus.com SDI Diagnostics Ten Hampden Drive Easton, MA 02375 800-678-5782 www.sdidiagnostics.com Sekisui Diagnostics One Wall Street Burlington, MA 01803 781-652-7800 www.sekisuidiagnostics. com Semler Scientific 2344 Walsh Ave Santa Clara, CA 95051 www.semlerscientific. 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
22 | PHYSICIANS OFFICE RESOURCE
972-3-5612212 www.shl-telemedicine. com Siemens Healthineers 40 Liberty Blvd Malvern, PA 19355 800-888-7436 www.usa.siemens.com Smiths Medical 5200 Upper Metro Place, Suite 200 Dublin, OH 43017 800-258-5361 www.smiths-medical. 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 Sysmex America, Inc. 577 Aptakisic Rd. Lincolnshire, IL 60069 866-779-7639 www.sysmex.com/us
T 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.tosohbiosciences. 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
V 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
Z Zanfel Laboratories, Inc. 1370 Northwest 114th St. #204 Clive, IA 50325 800-401-4002 www.zanfel.com Zoll 269 Mill Road Chelmsford, MA 01824 978-421-9655 www.zoll.com
HEALTH 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
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 Blood Disorders National Hemophilia Foundation www.hemophilia.org (212) 328-3700 Bone Marrow National Bone Marrow Transplant Link www.nbmtlink.org (800) 546-5268
Program www.cdc.gov/cancer/ nbccedp (800) 232-4636 Digestive Disorders/ Diseases Crohn’s & Colitis Foundation of America www.ccfa.org (800) 932-2423 Celiac Disease Foundation www.celiac.org (818) 716-1513 Eating Disorders National Eating Disorders Association www.nationaleatingdisorders.org (800) 931-2237 Eye Disease American Macular Degeneration Foundation www.macular.org (888) 622-8527
Bone Disease National Institute of Arthritis & Musculoskeletal & Skin Diseases www.niams.nih.gov (877) 226-4267
The Vision Council www.thevisioncouncil. org (866) 826-0290
Breast Disease National Breast & Cervical Cancer Early Detection
Glaucoma Research Foundation www.glaucoma.org (415) 986-3162
Fibromyalgia National Fibromyalgia Association www.fmaware.org Gastrointestinal Diseases International Foundation for Functional Gastrointestinal Disorders www.iffgd.org (414) 964-1799 Growth Disorders Human Growth Foundation www.hgfound.org (800) 451-6434 Hearing Disorders International Hearing Society www.ihsinfo.org (734) 522-7200 Heart Disease American Heart Association www.heart.org (800) 242-8721 Hepatitis C Hepatitis C Association www.hepcassoc.org (908) 769-8479 Hospital/Hospice Care Caring Connections www.caringinfo.org (703) 837-1500 2024 BUYERS GUIDE | 23
HEALTH AGENCY HOTLINES
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 Kidney Disease National Kidney Foundation www.kidney.org (800) 622-9010
www.minorityhealth.hhs. gov (800) 444-6472 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
Lead EPA Lead Information Center www.epa.gov/lead (800) 424-5323
Pancreatic Disease Pancreatic Cancer Action Network www.pancan.org (877) 573-9971
Liver Diseases American Liver Foundation www.liverfoundation.org (212) 668-1000
Paralysis and Spinal Injury Christopher & Dana Reeve Foundation www.christopherreeve.org (800) 539-7309
Lung Disease/Asthma/ Allergy American Lung Association www.lungusa.org (800) 586-4872
Parkinson’s Disease Parkinson’s Disease Foundation www.parkinson.org (800) 473-4636
Mental Health Mental Health America www.mentalhealthamerica. net (800) 969-6642
Minority Health US Department of Health and Human Services Office of Minority Health
Pediatrics American Academy of Pediatrics www.aap.org (800) 433-9016
Poison Control American Association of Poison Control Centers www.aapcc.org
24 | PHYSICIANS OFFICE RESOURCE
(800) 222-1222 Professionals American Medical Association www.ama-assn.org (800) 622-3211 Rehabilitation National Rehabilitation Info. Ctr. www.naric.com (800) 346-2742 Rheumatic Diseases Scleroderma Foundation www.scleroderma.org (800) 722-4673 Sexually Transmitted Diseases CDC Sexually Transmitted Diseases Info. www.cdc.gov/std/ (800) 232-4636 Skin Disease 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
Surgery/Facial Plastic Surgery American Society of Plastic Surgeons
www.plasticsurgery.org (847) 228-9900 Thyroid Disease American Thyroid Association www.thyroid.org (703) 998-8890 Veterans Veterans Special Issue Helpline Department of Veterans Affairs www.va.gov (844) 698-2311 VA Suicide Prevention www.mentalhealth.va.gov (844) 698-2311 Vision Disorders American Council of the Blind www.acb.org (800) 424-8666
GOVERNMENT
ORGANIZATIONS Agency for Healthcare Research and Quality (301) 427-1104 www.ahrq.gov Center for Disease Control and Prevention (800) 232-4636 www.cdc.gov Centers for Medicare & Medicaid Services (800) 633-4227 www.cms.gov National Institute on Aging (800) 222-2225 www.nia.nih.gov National Institute on Alcohol Abuse and Alcoholism (NIAAA) (301) 443-2857 www.niaaa.nih.gov National Institute of Allergy and Infectious Diseases (866) 284-4107 www.niaid.nih.gov National Institute of Arthritis and Musculoskeletal and Skin Disease (877) 226-4267 www.niams.nih.gov National Institute of Biomedical Imaging and Bioengineering (301) 496-8859 www.nibib.nih.gov National Institute of Child Health & Human Development (800) 370-2943 www.nichd.nih.gov
National Institute of Dental and Craniofacial Research (866) 232-4528 www.nidcr.nih.gov National Institute of Diabetes and Digestive and Kidney Disease (800) 860-8747 www.niddk.nih.gov National Institute of Environmental Health Sciences (919) 541-3345 www.niehs.nih.gov National Institute of Mental Health (866) 615-6464 www.nimh.nih.gov National Institute of Nursing Research (301) 496-0207 www.ninr.nih.gov National Institute on Drug Abuse (301) 443-1124 www.drugabuse.gov National Institutes of Health (301) 496-4000 www.nih.gov Occupational Safety & Health Administration (800) 321-6742 www.osha.gov U.S. Department of Health & Human Services (877) 696-6775 www.hhs.gov U.S. National Library of Medicine (301) 496-6308 www.nlm.nih.gov
2024 BUYERS GUIDE | 25
STATE MEDICAL
ASSOCIATIONS Alabama www.alamedical.org (800) 239-6272
Illinois www.isms.org (800) 782-4767
Montana www.mmaoffice.org (406) 443-4000
Rhode Island www.rimed.org (401) 331-3207
Alaska www.asmadocs.org (907) 562-0304
Indiana www.ismanet.org (800) 257-4762
Nebraska www.nebmed.org (402) 474-4472
South Carolina www.scmedical.org (800) 327-1021
Arizona www.azmed.org (602) 347-6900
Iowa www.iowamedical.org (515) 223-1401
Nevada www.nvdoctors.org (775) 825-6788
South Dakota www.sdsma.org (605) 336-1965
Arkansas www.arkmed.org (501) 224-8967
Kansas www.kmsonline.org (800) 332-0156
New Hampshire www.nhms.org (603) 224-1909
Tennessee www.tnmed.org (615) 385-2100
California www.cmanet.org (800) 786-4262
Kentucky www.kyma.org (502) 426-6200
New Jersey www.msnj.org (609) 896-1766
Texas www.texmed.org (800) 880-1300
Colorado www.cms.org (720) 859-1001
Louisiana www.lsms.org (225) 763-8500
New Mexico www.nmms.org (505) 828-0237
Utah www.utahmed.org (801) 747-3500
Connecticut www.csms.org (203) 865-0587
Maine www.mainemed.com (207) 622-3374
New York www.mssny.org (516) 488-6100
Vermont www.vtmd.org (802) 223-7898
District of Columbia www.msdc.org (202) 466-1800
Maryland www.medchi.org (800) 492-1056
North Carolina www.ncmedsoc.org (919) 833-3836
Virginia www.msv.org (800) 746-6768
Delaware www.medsocdel.org (302) 366-1400
Massachusetts www.massmed.org (781) 893-4610
North Dakota www.ndmed.org (701) 223-9475
Washington www.wsma.org (206) 441-9762
Florida www.flmedical.org (850) 224-6627
Michigan www.msms.org (517) 337-1351
Ohio www.osma.org (800) 766-6762
West Virginia www.wvsma.org (304) 925-0342
Georgia www.mag.org (678) 303-9290
Minnesota www.mnmed.org (612) 378-1875
Oklahoma www.okmed.org (800) 522-9452
Hawaii www.hawaiimedicalassociation.org (808) 536-7702
Mississippi www.msmaonline.com (601) 853-6733
Oregon www.theoma.org (503) 619-8000
Wisconsin www.wisconsinmedicalsociety.org (608) 442-3800
Missouri www.msma.org (573) 636-5151
Pennsylvania www.pamedsoc.org (800) 228-7823
Idaho www.idmed.org (208) 344-7888
26 | PHYSICIANS OFFICE RESOURCE
Wyoming www.wyomed.org (307) 635-2424
PHOTOMETRIC ELECTROLYTES for CHEMISTRY ANALYZERS Electrolytes can now run just like other chemistries. Avoid extra cost and maintenance associated with ISE. BENCHTOP
Diazyme DZ-Lite™ c270
up to 270 photometric tests/hr 60+ CLIA moderate complexity assays Including: 3407
9 Cancer Markers 9 Cardiovascular Markers 9 Coagulation Markers 9 Diabetic Markers 9 Inflammatory Markers 9 Liver Markers
9 Renal / Pancreatic Markers 9 Sepsis Markers 9 Vitamin Markers 9 Photometric Electrolytes 9 Drugs of Abuse
FLOOR MODEL
up to 400 photometric tests/hr 30+ CLIA moderate complexity assays Choose ISE or Photometric Electrolytes 3408
Installation and training included
call 877-722-8910 carolinachemistries.com
PRODUCT
CATEGORIES A1C Abbott www.globalpointofcare. abbott Hemocue America www.Hemocue.com Siemens Healthcare Diagnostics www.siemens-healthineers.com
Premier Medical Products www.premusa.com
ALBUMIN Siemens Healthcare Diagnostics www.siemens-healthineers.com ALLERGY Jant Pharmacal www.accutest.net
ABI Huntleigh Diagnostics www.huntleigh-diagnostics.com
Jant Pharmacal www.medicaldevicedepot.com
Medical Device Depot www.medicaldevicedepot.com
ASTHMA TESTING Micro Direct www.mdspiro.com
Newman Medical www.newman-medical. com
Vitalograph www.vitalograph.com
ACNE Treatment Theravant Corp www.theraclear.com
AUDIOMETRY Ototronix www.ototronixdiagnostics.com
AESTHETICS Aerolase www.aerolase.com
AUGMENTED MEDICINE Medpod www.medpodhealth.com
Alma Lasers www.almalasers.com Cutera www.cutera.com
BLOOD GAS Abbott Point of Care www.globalpointofcare. abbott
CryoProbe www.ho-equipments.com
Nova Biomedical www.novabiomedical.com
DermaMed www.dermamedsolutions. com
BLOOD PRESSURE Medical Device Depot www.medicaldevicedepot.com
Orasure Histofreezer www.histofreezer.com 28 | PHYSICIANS OFFICE RESOURCE
Vitalograph www.vitalograph.com
Nasiff Associates, Inc. www.nasiff.com
Welch Allyn www.welchallyn.com
ndd Medical Technologies www.nddmed.com
BONE HEALTH Bone Index Ltd. www.bindex.us
Nihon Kohden www.nohonkohden.com Nonin Medical www.nonin.com
BRAIN ASSESMENT Evoke Neuroscience www.evokeneuroscience. 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
Schiller America, Inc. www.schillerus.com SDI Diagnostics Inc. www.sdidiagnostics.com 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 www.arkrayusa.com
PRODUCT CATEGORIES Carolina Liquid Chemistries, Inc. www.carolinachemistries. com ELITech Group www.elitechgroup.com Horiba Medical www.horiba.com/us/en/ medical Jant Pharmacal www.accutest.net Medica Corporation www.medicacorp.com
Medica Corporation www.medicacorp.com PTS Diagnostics www.ptsdiagnostics.com Randox Laboratories, Inc. www.randox.com COAGULATION Roche www.roche.com CONJUNCTIVITIS TESTS RPS Diagnostics www.rpsdetectors.com
Randox Laboratories, USA www.randox.com
COVID-19 TESTS BD https://bdveritor.bd.com/ en-us
Roche www.roche.com
bioMerieux www.biomerieux.com
Sekisui www.sekisuidiagnostics. com
LumiraDx www.lumiradx.com
Vital Diagnostics www.vitaldiagnostics.com
CHOLESTEROL & TRIGLYCERIDE TESTING Abbott www.globalpointofcare. abbott Alfa Wassermann, Inc www.alfawassermannus. com Arkray www.arkrayusa.com Beckman Coulter, Inc. www.beckman.com Carolina Liquid Chemistries, Inc. www.carolinachemistries. com Horiba Medical www.horiba.com/us/en/ medical
Mercedes Scientific www.mercedesscientific. com Quidel www.quidel.com Sekisui www.sekisui.com CREATININE Siemens Healthcare Diagnostics www.siemens-healthineers.com CRYOSURGICAL DEVICES CryoProbe www.ho-equipments.com CryoConcepts, LP www.cryoconcepts.com DIABETES Abbott www.globalpointofcare. abbott Semler Scientific www.semlerscientific.com
Siemens Healthcare Diagnostics www.siemens-healthineers.com DEFIBRILLATORS Medical Device Depot www.medicaldevicedepot.com Zoll www.zoll.com DOPPLERS Huntleigh Diagnostics www.huntleigh-diagnostics.com Medical Device Depot www.medicaldevicedepot.com
HEINE Optotechnik www.heine.com Med-Electronics, Inc. www.med-electronics. com Welch Allyn, Inc. www.welchallyn.com ECG Edan Diagnostics www.edandiagnostics. com GE Healthcare Technologies www.gehealthcare.com Medical Device Depot www.medicaldevicedepot.com
Newman Medical www.newman-medical. com
Midmark Diagnostics, Inc. www.midmark.com
Wallach Surgical Devices www.wallachsurgical.com
Mortara www.mortara.com
DRUGS OF ABUSE TESTS Carolina Liquid Chemistries www.carolinachemistries. com
Schiller America, Inc. www.schilleramerica.com
Horiba www.horiba.com/us/en/ medical
Welch Allyn www.welchallyn.com
Laboratory Consulting, LLC www.urinedrugscreenconsulting.com Randox Laboratories, Inc. www.randox.com Sekisui www.sekisuidiagnostics. com
Vitalograph www.vitalograph.com
EDUCATION AAFP www.aafp.org COLA www.cola.org ELECTROLYTE Abbott Point of Care www.globalpointofcare. abbott Medica Corporation www.medicacorp.com
EAR, NOSE & THROAT Bionix www.bionix.com Brilliant Medical www.brilliantmedical.com
OPTI MEDICAL SYSTEMS, INC. Roche www.roche.com
2024 BUYERS GUIDE | 29
PRODUCT CATEGORIES ENDOSCOPY Pentax Medical www.pentaxmedical.com E-PRESCRIBING Amazing Charts www.amazingcharts.com DrFirst www.drfirst.com 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 FLU TESTING BD https://bdveritor.bd.com/ en-us bioMerieux www.BioFireDx.com Cepheid www.cepheid.com Quidel www.quidel.com
Roche www.Roche.com
Drucker Diagnostics, Inc. www.qbcdiagnostics.com
LABORATORY INFORMATION SYSTEMS
Sekisui www.sekisuidiagnostics. com
Hemocue, Inc. www.hemocue.com
Alfa Wassermann, Inc
GASTROINTESTINAL DISEASE TESTING bioMerieux www.biofiredx.com
Horiba Medical www.horiba.com/us/en/ medical Jant Pharmacal www.accutest.net
GLUCOSE TESTING Abbott Point of Care www.corelaboratory. abbott
Sysmex America, Inc. www.sysmex.com/us
Abbott Rapid Diagnostics www.globalpointofcare. abbott
HEMOGLOBIN ANALYZERS Abbott Rapid Diagnostics www.globalpointofcare. abbott
Hemocue, Inc. www.hemocue.com Jant Pharmacal www.jantdx.com Nova Biomedical www.novabiomedical.com Roche go.roche.com/rochelancets H. PYLORI Sekisui www.sekisuidiagnostics. com HCV – HIV TESTING Orasure www.orasure.com HEART DYSFUNCTION Semler Scientific www.semlerscientific.com HEMATOLOGY ANALYZERS Abbott www.corelaboratory.abbott/hematology ALCOR Scientific www.alcorescientific.com Beckman Coulter, Inc. www.beckmancoulter.com
30 | PHYSICIANS OFFICE RESOURCE
EKF DIAGNOSTICS Hemocue, Inc. www.hemocue.com Masimo Corporation www.masimo.com IMMUNOASSAY INSTRUMENTS Abbott Diagnostics www.corelaboratory. abbott BD https://bdveritor.bd.com/ en-us Beckman Coulter, Inc. www.beckmancoulter.com NanoEnTek www.nanoentek.com Sekisui Diagnostics www.sekisuidiagnostics. com INFECTIOUS DISEASE bioMerieux www.BioFireDx.com Roche www.roche.com Sekisui www.sekisui.com
Jant Pharmacal www.accutest.net Medicus LIS www.medicuslis.com Orchard Software www.orchardsoft.com LABORATORY SANATIZERS Clorox PDI LAB SERVICES AAFP www.aafp.org COLA www.cola.org COLA Resources Inc. www.criedu.org 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
PRODUCT CATEGORIES MOBILE HEALTH TECHNOLOGY Medpod www.medpodhealth.com MONITORS Edan Diagnostics www.edandiagnostics. com GE Healthcare Technologies www.gehealthcare.com Medical Device Depot www.medicaldevicedepot.com Midmark www.midmark.com Welch Allyn www.welchallyn.com NEUROLOGICAL TESTING Advanced Clinical Products www.advancedclinicalproducts.com Brilliant Medical www.brilliantmedical.com Evoke Neuroscience www.evokeneuroscience. com Morningside Medical Equipment www.morningsidemedicalequipment.com PAIN PRACTICE LAB Mercedes Medical www.mercedesmedical. com PERIPHERAL ARTERY DISEASE (PAD) Semler Scientific www.semlerscientific.com PHOTOTHERAPY SOLUTIONS Daavlin Company www.daavlin.com PRACTICE MANAGEMENT Athena Health www.athenahealth.com
ZirMed www.zirmed.com PT/INR Roche www.Roche.com PULSE OXIMETERS Masimo Corporation www.masimo.com REAGENTS Abbott Diagnostics www.corelaboratory. abbott Beckman Coulter www.beckmancoulter.com Carolina Liquid Chemistries, Inc. www.carolinachemistries. com Randox Laboratories, USA www.randox.com Sekisui www.sekisuidiagnostics. com RESPIRATORY INFECTIONS BD https://bdveritor.bd.com/ en-us bioMerieux www.BioFireDx.com Cepheid www.cepheid.com LumiraDx www.lumiradx.com Quidel www.quidel.com Roche www.Roche.com Sekisui www.sekisuidiagnostics. com SLEEP DISORDERS ResMed www.resmed.com
SPIROMETRY 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 ndd Medical Technologies www.nddmed.com Vitalograph www.vitalograph.com Welch Allyn www.welchallyn.com STREP TESTING Alere, Inc. www.alere.com BD https://bdveritor.bd.com/ en-us Cepheid www.cepheid.com Beckman Coulter, Inc. www.beckmancoulter.com LifeSign, LLC www.lifesignmed.com Quidel www.quidel.com Roche www.roche.com Sekisui www.sekisuidiagnostics. com SYNDROMIC TESTING bioMerieux www.BioFireDx.com
TELEHEALTH Medpod www.medpodhealth.com THERMOMETERS Exergen Corporation www.exergen.com TOXICOLOGY Abbott Clinical Laboratory Solutions www.diagnostics.abbott. com Mercedes Medical www.mercedesmedical. com ULTRASOUND Interson www.interson.com Samsung Medison www.samsungmedison. com URINALYSIS Abbott Rapid Diagnostics www.globalpointofcare. abbott Jant Pharmacal www.accutest.net LifeSign, LLC www.lifesignmed.com Roche www.roche.com Siemens Healthcare Diagnostics www.siemens-healthineers.com WOMEN’S HEALTH Sekisui Diagnostics www.sekisuidiagnostics. com WEIGHT MANAGEMENT Korr Medical Technologies, Inc. www.korr.com
2024 BUYERS GUIDE | 31
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THE STORY OF HIV PREVENTION with the first and only long-acting injectable PrEP option1
PrEP=pre-exposure prophylaxis.
APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart.
INDICATION
APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
IMPORTANT SAFETY INFORMATION BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen. Please see following pages for additional Important Safety Information. Please see following pages for Brief Summary of full Prescribing Information, including Boxed Warning, for APRETUDE.
Only with APRETUDE:
SUPERIOR efficacy proven in 2 trials and the CONFIDENCE that comes from adherence you can confirm in office1
SUPERIOR:
Provided greater protection from HIV than a daily oral PrEP (TDF/FTC) Significantly lower incidence of HIV-1 infection—69% (12* vs 39 [P=0.0003]) and 90% (3† vs 36 [P<0.0001])—vs a daily oral PrEP demonstrated in HPTN 083 and HPTN 0841-3‡§ • Of the incident and prevalent infections in the APRETUDE arm, INSTI resistanceassociated mutations (RAMs) were detected in 4 and 1 participant(s), respectively, in HPTN 083,1,4 and no major RAMs were detected in HPTN 0841 • Of the incident and prevalent infections in the TDF/FTC arm, NRTI RAMs were detected in 4 and 2 participants, respectively, in HPTN 083,4 and 1 incident infection with an NRTI RAM was detected in HPTN 0845
CONFIDENT:
Every-2-month dosing means no more daily PrEP pillsll Adherence you can confirm with as few as 6 in-office injections per year1¶ • See additional dosing and HIV-1 testing information at APRETUDEHCP.com
Would your patients benefit from a switch to long-acting APRETUDE?
Learn more about APRETUDE at APRETUDEHCP.com *In HPTN 083, the primary analysis showed a 66% reduction in the risk of acquiring HIV-1 infection (hazard ratio [95% CI]: 0.34 [0.18-0.62]). Further testing revealed 1 of the infections on APRETUDE to be prevalent, yielding a 69% reduction in the risk of incident HIV-1 infection relative to TDF/FTC (hazard ratio [95% CI]: 0.31 [0.16-0.58]); incidence rate was 0.37/100 person-years for APRETUDE vs 1.22/100 person-years for TDF/FTC.1 † In HPTN 084, the primary analysis showed an 88% reduction in the risk of acquiring HIV-1 infection (hazard ratio [95% CI]: 0.12 [0.05-0.31]). Further testing revealed 1 of the infections on APRETUDE to be prevalent, yielding a 90% reduction in the risk of incident HIV-1 infection relative to TDF/FTC (hazard ratio [95% CI]: 0.10 [0.04-0.27]); incidence rate was 0.15/100 person-years for APRETUDE vs 1.85/100 person-years for TDF/FTC.1 ‡ HPTN 083 (N=4566) was a randomized, double-blind, placebo-controlled noninferiority trial of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in HIV-1–uninfected men and transgender women who have sex with men and have evidence of high-risk behavior for HIV-1 infection. The primary endpoint was the rate of incident HIV-1 infections among participants randomized to daily oral cabotegravir for up to 5 weeks followed by intramuscular injections of APRETUDE every 2 months compared with daily oral TDF/FTC (corrected for early stopping). The trial included the prespecified ability to test for superiority of APRETUDE over TDF/FTC.1,2 § HPTN 084 (N=3224) was a randomized, double-blind, placebo-controlled superiority trial of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in adult, uninfected cisgender women at risk of acquiring HIV-1. The primary endpoint was the rate of incident HIV-1 infections among participants randomized to daily oral cabotegravir for up to 5 weeks followed by injections of APRETUDE compared with oral TDF/FTC (corrected for early stopping).1,3 || While on APRETUDE. ¶ After initiation injections.1
IMPORTANT SAFETY INFORMATION (cont’d) CONTRAINDICATIONS
• Do not use APRETUDE in individuals:
° with unknown or positive HIV-1 status ° with previous hypersensitivity reaction to cabotegravir ° receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
Please see following pages for additional Important Safety Information. Please see following pages for Brief Summary of full Prescribing Information, including Boxed Warning, for APRETUDE.
INCLUSIVE:
Evaluated across a diverse population The most diverse and comprehensive participant population in HIV prevention trials conducted to date1-3‡§ • Designed to include key populations at risk for HIV-1: Trials included HIV-1–negative cisgender men and transgender women who have sex with men and cisgender women, with the majority under age 301-3,6 • In the US, HPTN 083 was inclusive of the Black/African American and Latinx communities who comprise the greatest percentage of new HIV diagnoses1,2,7
SAFETY PROFILE1:
Demonstrated in ~4000 participants
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• The most common adverse reactions (all grades) observed in at least 1% of subjects receiving APRETUDE were ISRs, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection - In HPTN 083, 82% of participants who received APRETUDE experienced at least 1 ISR; 97% were Grade 1 or 2, with 3% of participants experiencing Grade 3 and no Grade 4 reactions reported - In HPTN 084, 38% of participants who received APRETUDE experienced at least 1 ISR; >99% were Grade 1 or 2, with <1% of participants experiencing Grade 3 and no Grade 4 reactions reported • 6% of participants receiving APRETUDE and 4% receiving TDF/FTC in HPTN 083, and 1% of participants in both arms of HPTN 084, discontinued due to adverse events (all causality) CI=confidence interval; HPTN=HIV Prevention Trials Network; INSTI=integrase strand transfer inhibitor; ISR=injection-site reaction; NRTI=nucleoside/ nucleotide reverse transcriptase inhibitor; PrEP=pre-exposure prophylaxis; TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.
IMPORTANT SAFETY INFORMATION (cont’d) WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection: • Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner(s) HIV-1 status, including viral suppression status; regular testing for STIs) • Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
IMPORTANT SAFETY INFORMATION (cont’d) WARNINGS AND PRECAUTIONS (cont’d)
Comprehensive Management to Reduce the Risk of HIV-1 Infection: (cont’d) • When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs • If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following an exposure event, additional HIV testing to determine HIV status is needed. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment • Counsel HIV-1 uninfected individuals to strictly adhere to the recommended dosing and testing schedule for APRETUDE Potential Risk of Resistance with APRETUDE: • There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. Alternative forms of PrEP should be considered following discontinuation of APRETUDE for those individuals at continuing risk of HIV-1 acquisition and initiated within 2 months of the final injection of APRETUDE Long-Acting Properties and Potential Associated Risks with APRETUDE: • Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence to every-2-month injections or missed doses could lead to HIV-1 acquisition and development of resistance Hypersensitivity Reactions: • Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE • Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated Hepatotoxicity: • Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors • Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated
Talk to your patients about long-acting HIV prevention with APRETUDE
Learn more at APRETUDEHCP.com
Trademarks are owned by or licensed to the ViiV Healthcare group of companies. ©2023 ViiV Healthcare or licensor. CBTJRNA230005 May 2023 Produced in USA.
IMPORTANT SAFETY INFORMATION (cont’d) WARNINGS AND PRECAUTIONS (cont’d)
Depressive Disorders: • Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE • Promptly evaluate patients with depressive symptoms Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions: • The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE • Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
DRUG INTERACTIONS
• Refer to the full Prescribing Information for important drug interactions with APRETUDE • Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
USE IN SPECIFIC POPULATIONS T:10.5"
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• Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation • Pediatrics: Not recommended in individuals weighing less than 35 kg
Please see following pages for Brief Summary of full Prescribing Information, including Boxed Warning, for APRETUDE. References: 1. APRETUDE [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021. 2. Landovitz RJ, Donnell D, Clement ME, et al; HPTN 083 Study Team. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385:595-608. doi:10.1056/NEJMoa2101016 3. Delany-Moretlwe S; HPTN 084 Study Team. Long acting injectable cabotegravir is safe and effective in preventing HIV infection in cisgender women: results from HPTN 084. Presented at: HIV R4P Virtual Conference; January 27, 2021. Abstract LB1479. 4. Marzinke MA, Grinsztejn B, Fogel JM, et al. Characterization of human immunodeficiency virus (HIV) infection in cisgender men and transgender women who have sex with men receiving injectable cabotegravir for HIV prevention: HPTN 083. J Infect Dis. 2021;224(9):1581-1592. doi:10.1093/ infdis/jiab152 5. Marzinke MA, Delany-Moretlwe S, Agyei Y; HPTN 084 Study Team. Long-acting injectable PrEP in women: laboratory analysis of HIV infections in HPTN 084. Poster presented at: 11th International AIDS Society Conference on HIV Science; July 18-21, 2021. 6. HIV in the United States and dependent areas. Centers for Disease Control and Prevention. Updated August 9, 2021. Accessed March 11, 2022. https://www.cdc.gov/hiv/statistics/overview/ataglance.html 7. Centers for Disease Control and Prevention. HIV Surveillance Report, 2019. Vol 32. May 2021. https://www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-32/index.html
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BRIEF SUMMARY
APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular use The following is a brief summary only; see full Prescribing Information, including Boxed Warning, for complete product information. WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen. CONTRAINDICATIONS APRETUDE is contraindicated in individuals: with unknown or positive HIV-1 status; with previous hypersensitivity reaction to cabotegravir; receiving the following coadministered drugs for which significant decreases in cabotegravir plasma concentrations may occur due to uridine diphosphate glucuronosyltransferase (UGT)1A1 enzyme induction, which may result in reduced effectiveness– Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin; Antimycobacterials: rifampin, rifapentine.
ADVERSE REACTIONS 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 with rates in the clinical trials of another drug and may not reflect rates observed in practice. Clinical Trials Experience in Adults: The safety assessment of APRETUDE is based on the analysis of data from 2 international, multicenter, double-blind trials, HPTN 083 and HPTN 084. Adverse reactions were reported while on blinded study product following exposure to APRETUDE extended-release injectable suspension and oral cabotegravir tablets as oral lead-in. The median time on blinded study product in HPTN 083 was 65 weeks and 2 days (range: 1 day to 156 weeks and 1 day), with a total exposure on cabotegravir of 3,231 person-years. The median time on blinded study product in HPTN 084 was 64 weeks and 1 day (range: 1 day to 153 weeks and 1 day), with a total exposure on cabotegravir of 2,009 person-years. The most common adverse reactions regardless of severity reported in at least 1% of participants in HPTN 083 or HPTN 084 are presented in Table 4. In HPTN 083, 6% of participants in the group receiving APRETUDE intramuscular injection every 2 months and 4% of participants receiving oral TRUVADA [emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)] once daily discontinued due to adverse events (all causality). Noninjection-site–associated adverse events leading to discontinuation and occurring in ≥1% of participants were increased alanine aminotransferase with APRETUDE and TRUVADA. In HPTN 084, 1% of participants receiving APRETUDE and 1% of participants receiving TRUVADA discontinued due to adverse events. The most commonly reported adverse event (all causality) leading to discontinuation was increased alanine aminotransferase (<1%) with APRETUDE and TRUVADA. The side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trials. (cont’d on next page)
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WARNINGS AND PRECAUTIONS Comprehensive Management to Reduce the Risk of HIV-1 Infection: Use APRETUDE for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. The time from initiation of APRETUDE for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown. Risk for HIV-1 acquisition includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Counsel individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner(s)’ HIV-1 status, including viral suppression status; regular testing for STIs that can facilitate HIV-1 transmission). Inform individuals about and support their efforts in reducing sexual risk behavior. Use APRETUDE to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment; therefore, care should be taken to minimize the risk of initiating or continuing APRETUDE before confirming the individual is HIV-1 negative. Prior to initiating APRETUDE for HIV-1 PrEP, ask seronegative individuals about recent (in past month) potential exposure events (e.g., condomless sex or condom breaking during sex with a partner of unknown HIV-1 status or unknown viremic status, a recent STI), and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection. When using APRETUDE for HIV-1 PrEP, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs. If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following an exposure event, additional HIV testing to determine HIV status is needed. If an individual has confirmed HIV-1 infection, then the individual must be transitioned to a complete HIV-1 treatment regimen. Counsel HIV-1–uninfected individuals to strictly adhere to the recommended dosing and testing schedule for APRETUDE in order to reduce the risk of HIV-1 acquisition and the potential development of resistance. Some individuals, such as adolescents, may benefit from frequent visits and counseling to support adherence to the dosing and testing schedule. Potential Risk of Resistance with APRETUDE: There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before or while taking APRETUDE or following discontinuation of
APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1 negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered following discontinuation of APRETUDE for those individuals at continuing risk of HIV-1 acquisition and initiated within 2 months of the final injection of APRETUDE. Long-Acting Properties and Potential Associated Risks with APRETUDE: Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). It is important to carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence to every-2-monthly injections or missed doses could lead to HIV-1 acquisition and development of resistance. Healthcare providers should take the prolonged-release characteristics of cabotegravir into consideration when APRETUDE is prescribed. Hypersensitivity Reactions: Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE. Administration of cabotegravir oral lead-in dosing was used in clinical studies to help identify participants who may be at risk of a hypersensitivity reaction. Remain vigilant and discontinue APRETUDE if a hypersensitivity reaction is suspected. Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash, or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, mucosal involvement [oral blisters or lesions], conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing). Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. For information regarding the long-acting properties of APRETUDE, see previous section. Hepatotoxicity: Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors. Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated. For information regarding the long-acting properties of APRETUDE, see previous section. Depressive Disorders: Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicide ideation or attempt) have been reported with APRETUDE. Promptly evaluate individuals with depressive symptoms to assess whether the symptoms are related to APRETUDE and to determine whether the risks of continued therapy outweigh the benefits. Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions: The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE. See DRUG INTERACTIONS section below for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE.
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BRIEF SUMMARY for APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular use (cont'd) Table 4. Adverse Drug Reactionsa (All Grades) Reported in at Least 1% of Participants Receiving APRETUDE in Either HPTN 083 or HPTN 084
HPTN 083 Adverse Reactions
HPTN 084
APRETUDE TRUVADA APRETUDE TRUVADA Every Once Daily Every Once Daily 2 Months 2 Months (n = 2,281) (n = 2,285) (n = 1,614) (n = 1,610)
with the intramuscular administration of APRETUDE in HPTN 084 were ISRs. After 13,068 injections, 1,171 ISRs were reported. Of the 1,519 participants who received at least one injection of APRETUDE, 578 (38%) participants experienced at least one ISR. No participants discontinued APRETUDE because of ISRs. Among the participants who received APRETUDE and experienced at least one ISR, the maximum severity of reactions was mild (Grade 1) in 66% of participants, moderate (Grade 2) in 34% of participants, and severe (Grade 3) in less than 1% of participants. The median duration of overall ISR events was 8 days. The proportion of participants reporting ISRs at each visit and the severity of the ISRs generally decreased over time. The most commonly reported ISRs (all causality and grades) in at least 1% of participants who received APRETUDE and experienced at least one ISR from HPTN 084 are presented in Table 5.
Injection site reactionsb
82%
35%
38%
11%
Diarrhea
4%
5%
4%
4%
Headache
4%
3%
12%
13%
c
4%
<1%
<1%
<1%
d
Fatigue
4%
2%
3%
3%
Sleep disorderse
3%
3%
1%
1%
Nausea
3%
5%
4%
8%
Pain/ tenderness
98%
95%
90%
87%
Dizziness
2%
3%
4%
6%
Nodules
15%
2%
14%
2%
Flatulence
1%
1%
<1%
<1%
Induration
15%
<1%
12%
2%
Abdominal painf
1%
1%
2%
2%
Swelling
12%
1%
18%
3%
Vomiting
<1%
1%
2%
5%
Bruising
4%
4%
1%
0
Myalgia
<1%
<1%
2%
1%
Rashg
<1%
<1%
2%
1%
Decreased appetite
<1%
<1%
2%
4%
Pyrexia
Back pain Upper respiratory tract infection
<1% <1%
<1% <1%
2% 1%
Injection Site Reactions
HPTN 083
HPTN 084
APRETUDE TRUVADA (n = 1,740) (n = 724)
a
APRETUDE TRUVADAa (n = 578) (n = 166)
Erythema
4%
2%
5%
2%
Pruritus
3%
3%
6%
11%
Warmth
3%
1%
<1%
0
Anesthesia
1%
2%
1%
2%
2%
Abscess
<1%
0
2%
3%
<1%
Discoloration
<1%
0
1%
0
Placebo injectable suspension: intralipid 20% fat emulsion.
a
0
<1%
4%
4%
Adverse reactions defined as “treatment-related” as assessed by the investigator, with exception of injection site reactions, where all injection site reactions were reported regardless of causality. b Participants who received injection: HPTN 083, APRETUDE (n = 2,117) and TRUVADA (n = 2,081); HPTN 084, APRETUDE (n = 1,519) and TRUVADA (n = 1,516). c Pyrexia includes pyrexia, feeling hot, chills, influenza-like illness. d Fatigue includes fatigue, malaise. e Sleep disorders includes insomnia, abnormal dreams. f Abdominal pain includes abdominal pain, upper abdominal pain. g Rash includes rash, erythema, pruritus, macular, papular, maculopapular. a
Injection-Associated Adverse Reactions: Local Injection Site Reactions (ISRs) with APRETUDE: The most frequent adverse reactions associated with the intramuscular administration of APRETUDE in HPTN 083 were ISRs. After 20,286 injections, 8,900 ISRs were reported. Of the 2,117 participants who received at least one injection of APRETUDE, 1,740 (82%) participants experienced at least one ISR, of which a total of 3% of participants discontinued APRETUDE because of ISRs. Among the participants who received APRETUDE and experienced at least one ISR, the maximum severity of reactions was mild (Grade 1) in 41% of participants, moderate (Grade 2) in 56% of participants, and severe (Grade 3) in 3% of participants. The median duration of overall ISR events was 4 days. The proportion of participants reporting ISRs at each visit and the severity of the ISRs decreased over time. The most commonly reported ISRs (all causality and grades) in at least 1% of participants who received APRETUDE and experienced at least one ISR from HPTN 083 are presented in Table 5. The most frequent adverse reactions associated
Other Injection-Associated Adverse Reactions: In the HPTN 083 clinical trial, an increased incidence of pyrexia (including pyrexia, feeling hot, chills, influenza-like illness) (4%) was reported by participants receiving APRETUDE compared with participants receiving TRUVADA (<1%). There were no differences reported in the incidence of pyrexia between groups in HPTN 084. Vasovagal or pre-syncopal reactions considered treatment related were reported in <1% of participants after injection with APRETUDE in HPTN 083. None were reported as treatment related by the investigators in HPTN 084. Less Common Adverse Reactions: The following select adverse reactions (regardless of severity) occurred in <1% of participants receiving APRETUDE in HPTN 083 or HPTN 084: Hepatobiliary Disorders: Hepatotoxicity. Investigations: Weight increase (see below). Psychiatric Disorders: Depression. Weight Increase: At the Week 41 and Week 97 timepoints in HPTN 083, participants who received APRETUDE gained a median of 1.2 kg (Interquartile Range [IQR]; -1.0, 3.5; n = 1,623) and 2.1 kg (IQR; -0.9, 5.9; n = 601) in weight from baseline. Those who received TRUVADA gained a median of 0 kg (IQR; -2.1, 2.4; n = 1,611) and 1 kg (IQR; -1.9, 4.0; n = 598) in weight from baseline, respectively. At the Week 41 and 97 timepoints in HPTN 084, participants who received APRETUDE gained a median of 2 kg (IQR; 0.0, 5.0; n = 1,151) and 4 kg (IQR; 0.0, 8.0; n = 216) in weight from baseline, respectively. Those who received TRUVADA gained a median of 1 kg (IQR; -1.0, 4.0; n = 1,131) and 3 kg (IQR; -1.0, 6.0; n = 218) in weight from baseline, respectively. Laboratory Abnormalities: Grade 3 or 4 post-baseline maximum toxicity laboratory abnormalities for HPTN 083 or HPTN 084 are summarized in Table 6.
(cont’d on next page)
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Somnolence
Table 5. Injection Site Reactions (All Grades) Reported in at Least 1% of Participants who Experienced at Least One Injection Site Reaction (All Causality) with APRETUDE in Either HPTN 083 or HPTN 084
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BRIEF SUMMARY for APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular use (cont'd) Table 6. Laboratory Abnormalities (Grades 3 to 4) in ≥1% of Participants in Either HPTN 083 or HPTN 084
HPTN 083 Laboratory Parameter
HPTN 084
APRETUDE TRUVADA APRETUDE TRUVADA Every Once Every Once 2 Months Daily 2 Months Daily (n = 2,281) (n = 2,285) (n = 1,614) (n = 1,610)
ALT ( 5.0 x ULN)
2%
2%
<1%
1%
AST ( 5.0 x ULN)
3%
3%
<1%
<1%
15%
14%
2%
2%
Lipase ( 3.0 x ULN)
3%
3%
<1%
<1%
Creatinine (>1.8 x ULN or increase to 1.5 x baseline)
3%
3%
5%
4%
Creatine phosphokinase ( 10.0 x ULN)
ALT = Alanine transaminase, ULN = Upper limit of normal, AST = Aspartate aminotransferase.
Table 7. Fasting Lipid Values, Median Change from Baselinea at Week 57, Reported in HPTN 083 and HPTN 084
HPTN 083
HPTN 084
APRETUDE TRUVADA APRETUDE TRUVADA Total cholesterol (mg/dL)
+1.0
LDL cholesterol (mg/dL)
+1.0
-6.0
-1.1
-5.0
HDL cholesterol (mg/dL)
-0.2
-3.0
-0.8
-2.6
Triglycerides (mg/dL)
+2.7
0.0
+3.1
+0.7
Total cholesterol: HDL cholesterol ratio
+0.1
+0.0
+0.1
+0.1
-10.0
+0.2
-3.9
Nearly 60% of participants with baseline data available had Week 57 data available in both arms of both trials. Within each trial, baseline values were comparable among participants receiving APRETUDE and TRUVADA.
a
Clinical Trials Experience in Adolescents: In adolescents receiving APRETUDE for HIV-1 PrEP, the safety data were comparable to the safety data reported in adults receiving APRETUDE for HIV-1 PrEP. Postmarketing Experience The following adverse reactions have been identified during postmarketing use of cabotegravir-containing regimens. Because these reactions are reported voluntarily
Immune System Disorders Hypersensitivity reactions (including angioedema and urticaria). DRUG INTERACTIONS Use of Other Antiretroviral Drugs after Discontinuation of APRETUDE: Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). These residual concentrations are not expected to affect the exposures of antiretroviral drugs that are initiated after discontinuation of APRETUDE. Potential for Other Drugs to Affect APRETUDE: Cabotegravir is primarily metabolized by UGT1A1 with some contribution from UGT1A9. Drugs that are strong inducers of UGT1A1 or 1A9 are expected to decrease cabotegravir plasma concentrations; therefore, coadministration of APRETUDE with these drugs is contraindicated. Established and Other Potentially Significant Drug Interactions: Information regarding potential drug interactions with cabotegravir is provided below. These recommendations are based on either drug interaction trials following oral administration of cabotegravir or predicted interactions due to the expected magnitude of the interaction. The information below includes potentially significant interactions but is not all inclusive. • Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin – coadministration is contraindicated with APRETUDE due to potential for significant decreases in plasma concentration of APRETUDE • Antimycobacterials: rifampin, rifapentine – coadministration is contraindicated with APRETUDE due to potential for significant decreases in plasma concentration of APRETUDE • Antimycobacterial: rifabutin – when rifabutin is started before or concomitantly with the first initiation injection of APRETUDE, the recommended dosing of APRETUDE is one 600-mg (3-mL) injection, followed 2 weeks later by a second 600-mg (3-mL) initiation injection and monthly thereafter while on rifabutin. When rifabutin is started at the time of the second initiation injection or later, the recommended dosing schedule of APRETUDE is 600 mg (3 mL) monthly while on rifabutin. After stopping rifabutin, the recommended dosing schedule of APRETUDE is 600 mg (3 mL) every 2 months Drugs without Clinically Significant Interactions with Cabotegravir: Based on drug interaction study results, the following drugs can be coadministered with cabotegravir (non-antiretrovirals) or given after discontinuation of cabotegravir (antiretrovirals and non-antiretrovirals) without a dose adjustment: etravirine, midazolam, oral contraceptives containing levonorgestrel and ethinyl estradiol, and rilpivirine. Consult the full Prescribing Information for potential drug interactions; this list is not all inclusive. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to APRETUDE during pregnancy. Healthcare providers are encouraged to register individuals by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary: There are insufficient human data on the use of APRETUDE during pregnancy to adequately assess a drug-associated risk of birth defects and miscarriage. While there are insufficient human data to assess the risk of neural tube defects (NTDs) with exposure to APRETUDE during pregnancy, NTDs were associated with dolutegravir, another integrase inhibitor. Discuss the benefit-risk of using APRETUDE with individuals of childbearing potential or during pregnancy. Cabotegravir use in pregnant women has not been evaluated. APRETUDE should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus. The APR has been established to monitor for birth defects following prenatal exposure to antiretrovirals. The rate of miscarriage is not reported in the APR. The background rate for major birth defects in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) is 2.7%. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. The APR uses the MACDP as the U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at <20 weeks’ gestation. In animal reproduction studies with oral cabotegravir, a delay in the onset of parturition and increased stillbirths and neonatal deaths were observed in a rat pre- and postnatal development study at >28 times the exposure at the recommended human dose (RHD). No evidence of adverse developmental outcomes was observed with oral cabotegravir in (cont’d on next page)
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Serum Lipids: Changes from baseline to Month 15 in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and total cholesterol to HDL ratio in HPTN 083 and HPTN 084 are presented in Table 7.
from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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BRIEF SUMMARY for APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular use (cont'd) <15 mL/min), increased monitoring for adverse effects is recommended. In individuals with end-stage renal disease not on dialysis, effects on the pharmacokinetics of cabotegravir are unknown. As cabotegravir is >99% protein bound, dialysis is not expected to alter exposures of cabotegravir. Hepatic Impairment: Based on studies with oral cabotegravir, no dosage adjustment of APRETUDE is necessary for individuals with mild or moderate hepatic impairment (Child-Pugh A or B). The effect of severe hepatic impairment (Child-Pugh C) on the pharmacokinetics of cabotegravir is unknown. OVERDOSAGE There is no known specific treatment for overdose with APRETUDE. If overdose occurs, monitor the individual and apply standard supportive treatment as required as well as observation of the clinical status of the individual. As APRETUDE is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis. Consider the prolonged exposure to APRETUDE following an injection when assessing treatment needs and recovery.
ViiV Healthcare Durham, NC 27701
GlaxoSmithKline Durham, NC 27701
APR:2BRS March 2023 APRETUDE and CABENUVA are trademarks owned by or licensed to the ViiV Healthcare group of companies. The other brand listed is a trademark owned by or licensed to its respective owner and is not a trademark owned by or licensed to the ViiV Healthcare group of companies. The maker of this brand is not affiliated with and does not endorse the ViiV Healthcare group of companies or its products. ©2023 ViiV Healthcare or licensor. CBTJRNA230005 April 2023 Produced in USA.
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rats or rabbits (>28 times or similar to the exposure at the RHD, respectively) given during organogenesis (see Data). Clinical Considerations: Cabotegravir is detected in systemic circulation for up to 12 months or longer after discontinuing injections of APRETUDE; therefore, consideration should be given to the potential for fetal exposure during pregnancy. Data: Human Data: Data from a birth outcome surveillance study in Botswana showed that dolutegravir, another integrase inhibitor, was associated with increased risk of NTDs when administered at the time of conception and in early pregnancy. Data from clinical trials are insufficient to address this risk with cabotegravir. Animal Data: Cabotegravir was administered orally to pregnant rats at 0, 0.5, 5, or 1,000 mg/kg/day from 15 days before cohabitation, during cohabitation, and from Gestation Days 0 to 17. There were no effects on fetal viability when fetuses were delivered by caesarean, although a minor decrease in fetal body weight was observed at 1,000 mg/kg/day (>28 times the exposure in humans at the RHD). No drug-related fetal toxicities were observed at 5 mg/kg/day (approximately 13 times the exposure in humans at the RHD), and no drug-related fetal malformations were observed at any dose. Cabotegravir was administered orally to pregnant rabbits at 0, 30, 500, or 2,000 mg/kg/day from Gestation Days 7 to 19. No drug-related fetal toxicities were observed at 2,000 mg/kg/day (approximately 0.7 times the exposure in humans at the RHD). In a rat pre- and postnatal development study, cabotegravir was administered orally to pregnant rats at 0, 0.5, 5, or 1,000 mg/kg/day from Gestation Day 6 to Lactation Day 21. A delay in the onset of parturition and increases in the number of stillbirths and neonatal deaths by Lactation Day 4 were observed at 1,000 mg/kg/day (>28 times the exposure in humans at the RHD); there were no alterations to growth and development of surviving offspring. In a cross-fostering study, similar incidences of stillbirths and early postnatal deaths were observed when rat pups born to cabotegravir-treated mothers were nursed from birth by control mothers. There was no effect on neonatal survival of control pups nursed from birth by cabotegravirtreated mothers. A lower dose of 5 mg/kg/day (13 times the exposure at the RHD) was not associated with delayed parturition or neonatal mortality in rats. Studies in pregnant rats showed that cabotegravir crosses the placenta and can be detected in fetal tissue. Lactation: Risk Summary: It is not known if cabotegravir is present in human breast milk, affects human milk production, or has effects on the breastfed infant. When administered to lactating rats, cabotegravir was present in milk (see Data). If cabotegravir is present in human milk, residual exposures may remain for 12 months or longer after the last injections have been administered. Because of detectable cabotegravir concentrations in systemic circulation for up to 12 months or longer after discontinuing injections of APRETUDE, it is recommended that women breastfeed only if the expected benefit justifies the potential risk to the infant. Data: Animal Data: Animal lactation studies with cabotegravir have not been conducted. However, cabotegravir was detected in the plasma of nursing pups on Lactation Day 10 in the rat pre- and postnatal development study. Pediatric Use: The safety and effectiveness of APRETUDE for HIV-1 PrEP in at-risk adolescents weighing at least 35 kg is supported by data from 2 adequate and well-controlled trials of APRETUDE for HIV-1 PrEP in adults with additional safety and pharmacokinetic data from studies in HIV-1–infected adults who were administered CABENUVA, and in HIV-1–infected pediatric subjects who were administered separate components of CABENUVA in addition to their current antiretroviral therapy. APRETUDE for HIV-1 PrEP is being evaluated in 2 open-label multicenter clinical trials in adolescent individuals. Fifty-nine adolescents have been enrolled. Of these, 54 adolescent participants received one or more injections. In adolescents receiving APRETUDE for HIV-1 PrEP, the safety data were comparable to the safety data reported in adults receiving APRETUDE for HIV-1 PrEP. While using APRETUDE, HIV-1 testing should be conducted prior to initiating APRETUDE (with or without an oral leadin with oral cabotegravir) and prior to each injection of APRETUDE. Adolescents may benefit from more frequent visits and counseling to support adherence to the dosing and testing schedule. The safety, efficacy, and pharmacokinetics of APRETUDE in pediatric participants younger than 12 years of age or weighing <35 kg have not been established. Geriatric Use: No dose adjustment is required in elderly individuals. There are limited data available on the use of APRETUDE in individuals aged 65 years and older. In general, caution should be exercised in administration of APRETUDE in elderly individuals, reflecting greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Renal Impairment: Based on studies with oral cabotegravir, no dosage adjustment of APRETUDE is necessary for individuals with mild (creatinine clearance ≥60 to <90 mL/min) or moderate renal impairment (creatinine clearance ≥30 to <60 mL/min). In individuals with severe renal impairment (creatinine clearance 15 to <30 mL/min) or end-stage renal disease (creatinine clearance
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PRODUCT GUIDE
CATEGORIES 46 ABI
46
Bone Health
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Brain Function Assessment
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Cardiology
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Chemistry Analyzers
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CLIA Waived
55
COVID-19 Testing
57
Diabetes/Blood Glucose
59
Flu and Respiratory
61
Hematology
64
Laboratory Services
65
Multiplex Testing
65
Peripheral Arterial Disease
65
Spirometry
66
Strep Tests
67
Syndromic Testing
67
Toxicology
68
Urinalysis
69
Women’s Health
PRODUCT PRODUCTFEATURE FOCUS
ABI PAD TESTING SYSTEMS IDEAL FOR PRIMARY CARE TO VASCULAR SPECIALISTS from Newman Medical Your Patients Trust YOU To Find Their Peripheral Artery Disease • High-risk patients include those over 65, diabetics, and smokers. • If left untreated, 25% of patients with PAD will experience a heart attack or stroke within 5 years. • PAD symptoms are often mistaken for arthritis or old age. • The simpleABI Cuff-Link System is Easy to Learn and Use. • With a push-button remote, automatic calculations, and waveforms, it’s incredibly user-friendly. • Reports are straightforward to save and share since the system is PC-based.
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Outstanding Value and Reimbursements • The system pays for itself in less than a year with just one test per week. • Medicare reimbursements vary by exam and location, averaging from $91 to $174.
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BONE HEALTH WHY BINDEX® IS A GAME-CHANGER IN OSTEOPOROSIS DIAGNOSTICS. From Bindex Medical
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Comparable to DXA Extensive clinical research has proven Bindex to be 90% accurate in detecting osteoporosis. It can replace nearly 70% of DXA scans for patients with suspected osteoporosis. Fast and effective Using safe pulse-echo ultrasound to measure cortical bone thickness, Bindex analyzes bone density in just seconds. Easy to use anywhere Lightweight and pocket-sized, Bindex allows patients to receive onthe-spot bone density scans in doctors’ offices, hospitals and clinics and at home.
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BRAIN FUNCTION ASSESSMENT EARLIER DETECTION OF MEMORY LOSS, DEMENTIA AND OTHER COGNITIVE DISORDERS From Morningside Medical 3411
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
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BRAIN FUNCTION ASSESSMENT PRODUCT FOCUS
MEMORY LOSS BIOMARKERS TO AID IN DIAGNOSIS IN PRIMARY CARE PRACTICES From Evoke Neuroscience 3412
The eVox® System is an FDA 510(k) cleared medical device to aid primary and specialty care physicians in diagnosis of memory loss and other cognitive disorders. eVox® measures memory loss biomarkers that may aid in detecting memory loss sooner, identifying the root cause of memory loss, and performing a differential diagnosis. eVox® procedures are performed in-office and are reimbursable by Medicare and commercial payers.
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CARDIOLOGY QUANTAFLO® HD From Semler Scientific The QuantaFlo® HD application assists in the early detection of Heart Dysfunction (HD). As published in the Journal of Preventive Medicine, QuantaFlo HD showed a statistically significant correlation with cardiac echocardiography, which is a gold standard for diagnosing heart failure.1 The test is highly sensitive, able to detect even asymptomatic HD, and can be performed in the outpatient clinic or the home setting in approximately 5 mins. Results are available immediately and graded as either positive or negative for HD allowing for improved patient selection for echocardiography.
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1. Howell, S. C., & Master, R. C. (2023). Clinical Evaluation of Volume Plethysmography as an Aid for Diagnosis of Heart Failure in the Primary Care Setting. Journal of Preventive Medicine, 8(2). https://doi.org/https://preventive-medicine.imedpub.com/clinical-evaluation-of-volumeplethysmography-as-an-aid-for-diagnosis-of-heart-failure-in-the-primary-care-setting.pdf
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CHEMISTRY ANALYZERS DC-LINEATE CALIBRATION/ LINEARITY MATERIAL From SEKISUI Diagnostics
3414
The DC-Lineate is a unique, trilevel calibration/linearity material that is used in conjunction with assays for the quantitative determination of UIBC levels in clinical samples. The material is conveniently packaged in a 2 x 5 mL configuration for each of the three levels and is traceable back to the National Institute of Standards and Technology (NIST). It can be used on a broad range of clinical chemistry analyzers and has a shelf life up to 14-days after reconstitution.
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PRODUCT PRODUCTFEATURE FOCUS
CHEMISTRY ANALYZERS 3415
DIAZYME DZ-LITE™ C270 BENCHTOP GENERAL/SPECIAL CHEMISTRIES + DRUG SCREENS From Carolina Liquid Chemistries A fully-automated, open system, benchtop clinical chemistry analyzer with throughput up to 270 tests/hour, 36 reagent positions, and 30 sample positions. It features a menu of over 60 CLIA moderate complexity assays, including cancer markers, cardiovascular markers, coagulation markers, diabetic markers, inflammatory markers, liver markers, renal/pancreatic markers, sepsis markers, vitamin markers, photometric electrolytes, and drugs of abuse. To learn more, visit https://www.carolinachemistries.com/products/dz-lite-c270-benchtop-chemistry-analyzer/.
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FIRST EVER FDA-CLEARED AND CATEGORIZED, POINT-OF-CARE FENTANYL TEST (<6 MINUTES)
3416
From Carolina Liquid Chemistries Carolina Liquid Chemistries Corp. introduces the Fentanyl Urine Detection Test on CLC’s next-generation RYAN™ immunofluorescent analyzer. This FDA cleared and CLIA categorized, moderately complex, compact, point-of-care system detects fentanyl qualitatively in human urine at a cutoff concentration of 1.0 ng/mL. The test can be run in < 6 minutes, produces a chartable result, and is interfaceable. For detailed information, visit carolinachemistries.com/products/fentanyl-urinedetect-on-clc-ryan-analyzer/.
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3417
ENVOY500+ DELIVERING PROVEN RESULTS IN CLINICAL CHEMISTRY 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.
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CHEMISTRY ANALYZERS 3418
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.
PRODUCT FOCUS
TOXICOLOGY SCREENING SIMPLIFIED ABBOTT’S IMMTOX 270 BENCHTOP ANALYZER NOW WITH 14 ASSAYS CLIA CATEGORIZED AS MODERATE COMPLEXITY
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EASY, INTEGRATED WITH-PATIENT TESTING
Easy, Integrated With-Patient Testing I-STAT SYSTEM i-STAT System from Point PointofofCare Care at Abbott From Abbott
The handheld System offersaa broad broad menu of diagnostic tests at the patient’s The handheld i-STATi-STAT System offers menu of diagnostic tests at the side in just minutes. With just a few drops of blood, the i-STAT System delivers real time, patient’s lab-accurate side in justresults minutes. With just a few drops of blood, the i-STAT for a wide range of tests, including chemistries, blood gas, coaguSystem delivers realmarkers, time, lab-accurate results forand a wide of tests, lation, cardiac and more. Minimize delays wastedrange time with on-side tests. Easy, intuitive operation. including chemistries, blood gas, coagulation, cardiac markers, and more. MinimizeFor delays anduse wasted time with on-site tests.visit Easy, intuitive operation. intended and complete product information, pointofcare.abbott.
3419
Foruse in vitro use only.information, This materialvisit is intended for a U.S. audience only. i-STAT For intended and diagnostic complete product pointofcare.abbott. is a trademark of Abbott. Physician Office Resource i-STAT Product Description — US
For in vitro diagnostic use only. This material is intended for a U.S. audience only. 3064.REV1 08/20 i-STAT is a trademark of Abbott. Physician Office Resource i-STAT Product Description – US 3064.REV1 08/20
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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.
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49 | PHYSICIANS OFFICE RESOURCE
2024 BUYERS GUIDE | 49
CHEMISTRY ANALYZERS PRODUCT PRODUCTFEATURE FOCUS
FULL COMPLEMENT OF CLIA-WAIVED
Full Complement of CLIA-waived Blood Chemistry Tests BLOOD CHEMISTRY TESTS PICCOLO Piccolo Xpress® Chemistry Analyzer from Abbott
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 The Piccolo Xpress Chemistry Analyzer provides physician tests, offices including metabolic panels, lipids, liver, and kidney with lab-accurate results for a broad range offunction, CLIA- and more 3421with just waived general chemistry tests, metabolic 100 microliters of blood. Easyincluding to use, the Piccolopanels, Xpress provides live, and kidney function, and more with just 100 resultslipids, during a patient’s visit, accelerating treatment decisions, increasing microliters of blood. Easy to use, the PIccolo Xpress provides efficiency, and supporting patient satisfaction. Automated control on results during a patient’s visit, accelerating treatmentquality decisions, every increasing test helps ensure accuracy. efficiency, and supporting patient satisfaction. Automated quality control on every test helps ensure accuracy.
For in vitro diagnostic use only. This material is intended for a U.S. audience only. View Videos & Inc. More at POR.io Piccolo Xpress is aBrochures, registered trademark of Abaxis, and distributed by Abbott Point of Care. Physician Office Resource Piccolo Product Description – US 3065.REV1 08/20
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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.
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RX IMOLA From HORIBA Medical
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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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50 | PHYSICIANS OFFICE RESOURCE
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PRODUCT PRODUCTFEATURE FOCUS
CHEMISTRY ANALYZERS 3425
TOXICOLOGY URINE DRUG SCREENING REAGENTS 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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CLIA WAIVED 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.
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3426
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.
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52 | PHYSICIANS OFFICE RESOURCE
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CLIA WAIVED BIOFIRE SPOTFIRE
3428
bioMérieux knows that an evolving world deserves evolved diagnostics. Our latest innovation, the BIOFIRE® SPOTFIRE® Respiratory Solution, is the first FDA-cleared and CLIA-waived COVID-19 testing solution. The BIOFIRE® SPOTFIRE® System is an easy-to-use system that runs the BIOFIRE® SPOTFIRE® Respiratory (R) Panel. Benefits of the SPOTFIRE Respiratory Solution include: 15 respiratory targets on 1 PCR test with results in about 15 minutes; minimal benchtop space with vertical scalability up to four modules; easy to use with an intuitive user interface.
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PRODUCT FOCUS
From bioMerieux
ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OFCARE 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.
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OSOM® BVBLUE® From Sekisui Diagnostics
3430
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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2024 BUYERS GUIDE | 53
PRODUCT PRODUCTFEATURE FOCUS
CLIA WAIVED 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 a 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.
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OSOM ULTRA PLUS FLU A&B TEST From Sekisui Diagnostics 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.
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• 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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3433
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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54 | PHYSICIANS OFFICE RESOURCE
CLIA WAIVED
From Sekisui Diagnostics
PRODUCT FOCUS
ULTRA HCG COMBO TEST
3434
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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3435
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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COVID-19 TESTING BD VERITOR™ PLUS SYSTEM
From BD Veritor™
3436
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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2024 BUYERS GUIDE | 55
COVID-19 TESTING PRODUCT PRODUCTFEATURE FOCUS
3437
BIOFIRE SPOTFIRE From bioMerieux bioMérieux knows that an evolving world deserves evolved diagnostics. Our latest innovation, the BIOFIRE® SPOTFIRE® Respiratory Solution, is the first FDA-cleared and CLIA-waived COVID-19 testing solution. The BIOFIRE® SPOTFIRE® System is an easy-to-use system that runs the BIOFIRE® SPOTFIRE® Respiratory (R) Panel. Benefits of the SPOTFIRE Respiratory Solution include: 15 respiratory targets on 1 PCR test with results in about 15 minutes; minimal benchtop space with vertical scalability up to four modules; easy to use with an intuitive user interface.
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WHY COMPROMISE? FAST AND RELIABLE RESULTS ARE NOW DELIVERED AT THE POINT OF CARE.
3438
From LumiraDx
Introducing the next generation in point-of-care diagnostics. With a growing menu of tests, LumiraDx uses a simple process that allows for more time with your patients by using microfluidic technology that delivers results in minutes. Learn more about rapid COVID-19 diagnostic solutions for your physician office at LumiraDx.com.
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3439
BE PREPARED FOR RESPIRATORY SEASONS WITH THE OSOM® COVID-19 ANTIGEN RAPID TEST From Sekisui The OSOM® COVID-19 Antigen Rapid Test is a lateral flow immunoassay that detects the SARS-CoV-2 nucleocapsid protein with a nasal swab in only 15 minutes at the point-of-care. The test is intended to be used by healthcare professionals or operators on patients suspected of COVID-19 within the first 7 days of symptom onset. The clinical performance compares favorably against polymerase chain reaction methodology, with a positive percent agreement of 95.1% and a negative percent agreement of 97%.
View Brochures, Videos & More at POR.io Enter Number 3439 in the Search Area OSOM® COVID-19 Antigen Rapid Test has not been FDA cleared or approved. It is authorized by FDA under an EUA for prescription use only. It has been authorized only for the detection of SARS-CoV-2 antigen, not for any other viruses or pathogens and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro 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 S360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
56 | PHYSICIANS OFFICE RESOURCE
COVID-19 TESTING
From Quidel
3440
Sofia® 2 Fluorescent Immunoassay Analyzer and Rapid Diagnostic Test Kits Sofia 2 takes rapid testing to a new level. Proven lateral-flow technology and advanced fluorescent chemistry are all integrated into this small benchtop analyzer which can be used in any point-of-care setting. Sofia 2 kits are easy to use and adaptable to any healthcare setting. Excellent performance, objectivity, quality control, LIS capabilities, and an expanding test menu make Sofia 2 the perfect solution for the physician’s office laboratory.
PRODUCT FOCUS
SOFIA® 2 FLUORESCENT IMMUNOASSAY ANALYZER AND RAPID DIAGNOSTIC TEST KITS
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DIABETES/BLOOD GLUCOSE LAB-ACCURATE RESULTS FOR ACR AND HBA1C
3441
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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ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OFCARE 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.
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3442
2024 BUYERS GUIDE | 57
DIABETES/BLOOD GLUCOSE PRODUCT PRODUCTFEATURE FOCUS
3443
COMPREHENSIVE IN-OFFICE DIABETES TESTING WITH THE DCA VANTAGE® AND CLINITEK STATUS®+ ANALYZERS From Siemens Healthineers Siemens Healthineers DCA Vantage® and CLINITEK Status® family of analyzers provide hemoglobin A1c (HbA1c) and albumin-tocreatinine ratio (ACR) testing at the point of care. Meet quality measures for A1c control and kidney disease check in minutes with CLIA-waived HbA1c testing and ACR1 ratio. Improve patient experience and overall outcome by providing actionable results in minutes. 1. Moderately complex on the DCA Vantage Analyzer. CLIA-waived on the CLINITEK Status+ Analyzer.
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INSULIN INSIGHTS
3444
From Semler Scientific Using algorithms that codify the ADA standards of care Insulin Insights’ game-changing technology empowers clinicians with actionable data to help inform insulin dosing decisions. This FDA-cleared software as a medical device aims to improve diabetic patient outcomes, lower glycated hemoglobin, and reduce the risk of long-term complications. It is the only comprehensive dosing solution for all patients and insulin regimens.
View Brochures, Videos & More at POR.io Enter Number 3444 in the Search Area
3445
NOVA PRIMARY BLOOD GLUCOSE REFERENCE ANALYZER From Nova Biomedical The U.S. FDA has cleared Nova Primary as a blood glucose reference analyzer that fills the need for a new reference analyzer to replace the YSI STAT PLUS 2300 (YSI, Inc., Yellow Springs, OH). Manufacturers of blood glucose measuring devices and clinical diabetes researchers have relied on the YSI 2300 as a reference and correlation analyzer. However, YSI, Inc. no longer supports the analyzer, and its discontinuation has left a critical industry void. With today’s FDA clearance, Nova Primary from Nova Biomedical is now available in the U.S. and worldwide.
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58 | PHYSICIANS OFFICE RESOURCE
DIABETES/BLOOD GLUCOSE QUANTAFLO® PAD QuantaFlo® PAD is an easy to use, accurate, point of care, non-invasive solution that aids in the early detection of peripheral arterial disease (PAD). This FDA cleared device can be administered by a medical aide in less than 5 minutes. As published in the Journal of Vascular Surgery and the American Journal of Preventive Medicine, QuantaFlo detected undiagnosed PAD in 31.6% of patients +65.1 QuantaFlo is portable and integrates with other technologies and platforms. It is ideal for both home and clinic environments.
3446
1. Smolderen KG, Ameli O, Chaisson CE, Heath K, Mena-Hurtado C. Peripheral Artery Disease Screening in the Community and 1-Year Mortality, Cardiovascular Events, and Adverse Limb Events, AJPM Focus (2022), https://doi.org/10.1016/j.focus.2022.100016
PRODUCT FOCUS
From Semler Scientific
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FLU AND RESPIRATORY 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.
3447
BD VERITOR™ PLUS SYSTEM
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3448
From BD Veritor™
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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2024 BUYERS GUIDE | 59
FLU AND RESPIRATORY PRODUCT PRODUCTFEATURE FOCUS
3449
BIOFIRE SPOTFIRE From bioMerieux bioMérieux knows that an evolving world deserves evolved diagnostics. Our latest innovation, the BIOFIRE® SPOTFIRE® Respiratory Solution, is the first FDA-cleared and CLIA-waived COVID-19 testing solution. The BIOFIRE® SPOTFIRE® System is an easy-to-use system that runs the BIOFIRE® SPOTFIRE® Respiratory (R) Panel. Benefits of the SPOTFIRE Respiratory Solution include: 15 respiratory targets on 1 PCR test with results in about 15 minutes; minimal benchtop space with vertical scalability up to four modules; easy to use with an intuitive user interface.
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SOFIA® 2 FLUORESCENT IMMUNOASSAY ANALYZER AND RAPID DIAGNOSTIC TEST KITS From Quidel
3450
Sofia® 2 Fluorescent Immunoassay Analyzer and Rapid Diagnostic Test Kits Sofia 2 takes rapid testing to a new level. Proven lateral-flow technology and advanced fluorescent chemistry are all integrated into this small benchtop analyzer which can be used in any point-of-care setting. Sofia 2 kits are easy to use and adaptable to any healthcare setting. Excellent performance, objectivity, quality control, LIS capabilities, and an expanding test menu make Sofia 2 the perfect solution for the physician’s office laboratory.
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OSOM ULTRA PLUS FLU A&B TEST From Sekisui Diagnostics 3451
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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60 | PHYSICIANS OFFICE RESOURCE
HEMATOLOGY PRODUCT FOCUS
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.
View Brochures, Videos & More at POR.io Enter Number 2266 in the Search Area
3452
TURN SMALL PLACES INTO SMART SPACES
3453
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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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.
3454
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2024 BUYERS GUIDE | 61
HEMATOLOGY PRODUCT PRODUCTFEATURE FOCUS
CELL-DYN EMERALD 22 HEMATOLOGY ANALYZER From Abbott The CELL-DYN Emerald 22 is a full performance 5-part hematology analyzer for smaller clinical laboratories seeking productivity in smaller spaces. Benefits: • Compact Design - To conserve valuable workspace. • Small and Powerful - Includes a numeric keypad entry, reagent tray, and integrated color touchscreen monitor. • Easy and Automated - Barcoded reagents and touch-free scheduled daily maintenance, startup and shutdown. • Online product training - Self-pace training available 24x7 on the Abbott’s Hematology Academy.
3455
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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.
3456
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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.
3457
62 | PHYSICIANS OFFICE RESOURCE
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RIGHT SIZE. RIGHT PERFORMANCE. THE RIGHT FIT FOR YOUR LABORATORY.
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3458
CELL-DYN EMERALD 22 A suite of harmonized hematology solutions to meet the needs of your laboratory Support diverse test volumes
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Technological sophistication for routine and specialized testing
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Commutable results
CELL-DYN EMERALD 22 AL
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3460
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3461
CELL-DYN RUBY
CORELABORATORY.ABBOTT/HEMATOLOGY © 2022 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. CELL-DYN Ruby and CELL-DYN Emerald 22 AL are Class I laser products. For in vitro diagnostic use only. ADD-142016-GBL-EN 10/22
PRODUCT PRODUCTFEATURE FOCUS
HEMATOLOGY 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.
3462
View Brochures, Videos & Mores at POR.io Enter Number 3462 in the Search Area
LABORATORY SERVICES 3463
MEDICUS LIS
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
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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64 | PHYSICIANS OFFICE RESOURCE
3464
MULTIPLEX TESTING BIOFIRE SPOTFIRE From bioMerieux bioMérieux knows that an evolving world deserves evolved diagnostics. Our latest innovation, the BIOFIRE® SPOTFIRE® Respiratory Solution, is the first FDA-cleared and CLIA-waived COVID-19 testing solution. The BIOFIRE® SPOTFIRE® System is an easy-to-use system that runs the BIOFIRE® SPOTFIRE® Respiratory (R) Panel. Benefits of the SPOTFIRE Respiratory Solution include: 15 respiratory targets on 1 PCR test with results in about 15 minutes; minimal benchtop space with vertical scalability up to four modules; easy to use with an intuitive user interface.
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PRODUCT FOCUS
3465
PERIPHERAL ARTERIAL DISEASE QUANTAFLO® HD From Semler Scientific The QuantaFlo® HD application assists in the early detection of Heart Dysfunction (HD). As published in the Journal of Preventive Medicine, QuantaFlo HD showed a statistically significant correlation with cardiac echocardiography, which is a gold standard for diagnosing heart failure.1 The test is highly sensitive, able to detect even asymptomatic HD, and can be performed in the outpatient clinic or the home setting in approximately 5 mins. Results are available immediately and graded as either positive or negative for HD allowing for improved patient selection for echocardiography. 1. Howell, S. C., & Master, R. C. (2023). Clinical Evaluation of Volume Plethysmography as an Aid for Diagnosis of Heart Failure in the Primary Care Setting. Journal of Preventive Medicine, 8(2). https://doi.org/https://preventive-medicine.imedpub.com/clinical-evaluation-of-volume-
3466
plethysmography-as-an-aid-for-diagnosis-of-heart-failure-in-the-primary-care-setting.pdf
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PAD TESTING SYSTEMS IDEAL FOR PRIMARY CARE TO VASCULAR SPECIALISTS from Newman Medical
3467
Your Patients Trust YOU To Find Their Peripheral Artery Disease • High-risk patients include those over 65, diabetics, and smokers. • If left untreated, 25% of patients with PAD will experience a heart attack or stroke within 5 years. • PAD symptoms are often mistaken for arthritis or old age. The simpleABI Cuff-Link System is Easy to Learn and Use. • With a push-button remote, automatic calculations, and waveforms, it’s incredibly user-friendly. • Reports are straightforward to save and share since the system is PC-based. Outstanding Value and Reimbursements • The system pays for itself in less than a year with just one test per week. • Medicare reimbursements vary by exam and location, averaging from $91 to $174.
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PRODUCT PRODUCTFEATURE FOCUS
SPIROMETRY MD6300 MICRO SPIROMETER FULL FUNCTION LOW COST SPIROMETER From Mirco Direct
The Micro Spirometer is the newest offering in the Micro Direct spirometer line. Specifically designed for situations where low cost, precision spirometry measurements are required, the Micro Spirometer is lightweight and portable making it suitable for the physician office. The Micro Spirometer features a large color touch screen that is icon driven. The Micro Spirometer is supplied with Device Studio. A PC software for producing printouts of tests results or for creating PDF reports for attachment to the patients’ EMR file.
3468
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MD6800 PNEUMOTRAC SPIROMETER A POWERFUL SOLUTION FOR PC-BASED SPIROMETRY From Micro Direct
The Pneumotrac connects to your PC by USB and captures reliable tests results immediately using the Spirotrac 6 software. These results can be printed or shared easily with compatible EMR systems. The Pneumotrac features a highly accurate, extremely stable Fleisch pneumotrach and meets the latest 2019 ATS/ERS standardization of spirometry ensuring testing meets the most up-to-date guidelines. Real-time curves and new animated incentives encourage maximal patient performance and obtain prompt quality feedback using the latest test session/session acceptability, usability and repeatability criteria.
3469
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STREP TESTS SOFIA® 2 FLUORESCENT IMMUNOASSAY ANALYZER AND RAPID DIAGNOSTIC TEST KITS
From Quidel
Sofia® 2 Fluorescent Immunoassay Analyzer and Rapid Diagnostic Test Kits Sofia 2 takes rapid testing to a new level. Proven lateral-flow technology and advanced fluorescent chemistry are all integrated into this small benchtop analyzer which can be used in any point-of-care setting. Sofia 2 kits are easy to use and adaptable to any healthcare setting. Excellent performance, objectivity, quality control, LIS capabilities, and an expanding test menu make Sofia 2 the perfect solution for the physician’s office laboratory.
View Brochures, Videos & More at POR.io Enter Number 3470 in the Search Area 66 | PHYSICIANS OFFICE RESOURCE
3470
STREP TESTS OSOM ULTRA PLUS FLU A&B TEST From Sekisui Diagnostics 3471
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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SYNDROMIC TESTING BIOFIRE® FILMARRAY® TORCH From bioMérieux 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 benchtop footprint of the BIOFIRE TORCH saves precious lab space, and its scalability meets high throughput demands. BIOFIRE® FILMARRAY® Link Software automatically uploads patient results. Fully compatible with all BIOFIRE® FILMARRAY® Panels intended for use in CLIA-moderate settings, the BIOFIRE TORCH helps you maximize efficiency and productivity.
3472
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TOXICOLOGY 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.
3473
View Brochures, Videos & More at POR.io Enter Number 3473 in the Search Area 2024 BUYERS GUIDE | 67
PRODUCT PRODUCTFEATURE FOCUS
TOXICOLOGY TOXICOLOGY URINE DRUG SCREENING REAGENTS
3474
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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FIRST EVER FDA-CLEARED AND CATEGORIZED, POINT-OF-CARE FENTANYL TEST (<6 MINUTES) From Carolina Liquid Chemistries
3475
Liquid Chemistries Corp. introduces the Fentanyl Urine Detection Test on CLC’s next-generation RYAN™ immunofluorescent analyzer. This FDA cleared and CLIA categorized, moderately complex, compact, pointof-care system detects fentanyl qualitatively in human urine at a cutoff concentration of 1.0 ng/mL. The test can be run in < 6 minutes, produces a chartable result, and is interfaceable. For detailed information, visit carolinachemistries.com/products/fentanyl-urine-detect-on-clc-ryan-analyzer/.
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URINALYSIS COMPREHENSIVE IN-OFFICE DIABETES TESTING WITH THE DCA VANTAGE® AND CLINITEK STATUS®+ ANALYZERS From Siemens Healthineers Siemens Healthineers DCA Vantage® and CLINITEK Status® family of analyzers provide hemoglobin A1c (HbA1c) and albuminto-creatinine ratio (ACR) testing at the point of care. Meet quality measures for A1c control and kidney disease check in minutes with CLIA-waived HbA1c testing and ACR1 ratio. Improve patient experience and overall outcome by providing actionable results in minutes. 1. Moderately complex on the DCA Vantage Analyzer. CLIA-waived on the CLINITEK Status+ Analyzer.
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3476
WOMEN'S HEALTH 3477
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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PRODUCT FOCUS
OSOM® BVBLUE®
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 a 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.
3478
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3479
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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2024 BUYERS GUIDE | 69
BRUKINSA: MAKE A POWERFUL IMPACT IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS
Hemorrhage Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage, including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.6% of patients treated with BRUKINSA monotherapy in clinical trials, with fatalities occurring in 0.3% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 30% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding. Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 24% of patients, most commonly pneumonia (11%), with fatal infections occurring in 2.9% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (22%), thrombocytopenia (8%) and anemia (7%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy. Grade 4 neutropenia occurred in 11% of patients, and Grade 4 thrombocytopenia occurred in 2.8% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.
Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 13% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer reported in 7% of patients. Other second primary malignancies included malignant solid tumors (5%), melanoma (1.2%), and hematologic malignancies (0.5%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Cardiac Arrhythmias Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 3.7% of 1550 patients treated with BRUKINSA monotherapy, including Grade 3 or higher cases in 1.7% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.2% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
ADVERSE REACTIONS In this pooled safety population, the most common adverse reactions, including laboratory abnormalities, in ≥30% of patients who received BRUKINSA (N=1550) included decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%).
THE ONLY BTKi APPROVED ACROSS 4 B-CELL MALIGNANCIES1-3 CLL
Superiority across lines of therapy*
1,4,5
*Superior PFS vs BR in 1L and superior PFS and ORR vs ibrutinib in 2L.
MCL
Powerful responses in R/R patients over ~3 years1,7
WM
#1 prescribed BTKi in previously untreated patients6
MZL
The only BTKi approved for R/R patients1-3
Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and embryo-fetal toxicity. In the (N=1550) pooled safety population, the most common adverse reactions, including laboratory abnormalities, in ≥30% of patients included neutrophil count decreased (42%), upper respiratory tract infection (39%), platelet count decreased (34%), hemorrhage (30%), and musculoskeletal pain (30%).1
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DRUG INTERACTIONS CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily. CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.
SPECIFIC POPULATIONS Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.
INDICATIONS BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) • Waldenström’s macroglobulinemia (WM) • Mantle cell lymphoma (MCL) who have received at least one prior therapy • Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen The MCL and MZL indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
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1L=first line; 2L=second line; BR=bendamustine+rituximab; BTKi=Bruton’s tyrosine kinase inhibitor; CLL=chronic lymphocytic leukemia; MCL=mantle cell lymphoma; MZL=marginal zone lymphoma; ORR=overall response rate; PFS=progression-free survival; WM=Waldenström’s macroglobulinemia. References: 1. BRUKINSA. Package insert. BeiGene, Ltd; 2023. 2. CALQUENCE. Package insert. AstraZeneca Pharmaceuticals LP; 2022. 3. IMBRUVICA. Package insert. Pharmacyclics LLC, Janssen Biotech, Inc; 2023. 4. Tam CS, Brown JR, Kahl BS, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022;23(8):1031-1043. 5. Brown JR, Eichhorst B, Hillmen P, et al. Zanubrutinib or ibrutinib in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2023;388(4):319-332. 6. Data on file. BeiGene, Ltd. 7. Song Y, Zhou K, Zou D, et al. Zanubrutinib in relapsed/refractory mantle cell lymphoma: long-term efficacy and safety results from a phase 2 study. Blood. 2022;139(21):3148-3158.
Please see Brief Summary of full Prescribing Information on following pages. BRUKINSA, BeiGene, and myBeiGene are registered trademarks owned by BeiGene, Ltd. or its affiliates. © BeiGene, Ltd. 2023 All Rights Reserved. 0923-BRU-PRC-213 12/2023
BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR BRUKINSA® (zanubrutinib) SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Mantle Cell Lymphoma BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.2 Waldenström’s Macroglobulinemia BRUKINSA is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) [see Clinical Studies (14.2)]. 1.3 Marginal Zone Lymphoma BRUKINSA is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.3)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.4 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma BRUKINSA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [see Clinical Studies (14.4)]. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Hemorrhage Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.6% of patients treated with BRUKINSA monotherapy in clinical trials, with fatalities occurring in 0.3% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 30% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre and post surgery depending upon the type of surgery and the risk of bleeding. 5.2 Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 24% of patients, most commonly pneumonia (11%), with fatal infections occurring in 2.9% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. 5.3 Cytopenias Grade 3 or 4 cytopenias, including neutropenia (22%), thrombocytopenia (8%), and anemia (7%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy [see Adverse Reactions (6.1)]. Grade 4 neutropenia occurred in 11% of patients, and Grade 4 thrombocytopenia occurred in 2.8% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted [see Dosage and Administration (2.4)]. Treat using growth factor or transfusions, as needed. 5.4 Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 13% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer, reported in 7% of patients. Other second primary malignancies included malignant solid tumors (5%), melanoma (1.2%), and hematologic malignancies (0.5%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. 5.5 Cardiac Arrhythmias Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 3.7% of 1550 patients treated with BRUKINSA monotherapy, including Grade 3 or higher cases in 1.7% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.2% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately [see Dosage and Administration (2.4)], and consider the risks and benefits of continued BRUKINSA treatment. 5.6 Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)]. 6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: • Hemorrhage [see Warnings and Precautions (5.1)] • Infections [see Warnings and Precautions (5.2)] • Cytopenias [see Warnings and Precautions (5.3)] • Second Primary Malignancies [see Warnings and Precautions (5.4)] • Cardiac Arrhythmias [see Warnings and Precautions (5.5)] 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 in the WARNINGS AND PRECAUTIONS reflect exposure to BRUKINSA as a single-agent in nine clinical trials, administered at 160 mg twice daily in 1445 patients and at 320 mg once daily in 105 patients. Among these 1550 patients, the median duration of exposure was 26 months, 80% of patients were exposed for at least 12 months, and 58% of patients were exposed for at least 24 months.
In this pooled safety population, the most common adverse reactions (≥30%), including laboratory abnormalities, included neutrophil count decreased (42%), upper respiratory tract infection (39%), platelet count decreased (34%), hemorrhage (30%), and musculoskeletal pain (30%). Mantle Cell Lymphoma (MCL) The safety of BRUKINSA was evaluated in 118 patients with MCL who received at least one prior therapy in two single-arm clinical trials, BGB-3111-206 [NCT03206970] and BGB-3111-AU-003 [NCT02343120] [see Clinical Studies (14.1)]. The median age of patients who received BRUKINSA in studies BGB-3111-206 and BGB-3111-AU-003 was 62 years (range: 34 to 86), 75% were male, 75% were Asian, 21% were White, and 94% had an ECOG performance status of 0 to 1. Patients had a median of 2 prior lines of therapy (range: 1 to 4). The BGB-3111-206 trial required a platelet count ≥75 x 109/L and an absolute neutrophil count ≥1 x 109/L independent of growth factor support, hepatic enzymes ≤2.5 x upper limit of normal, total bilirubin ≤1.5 x ULN. The BGB-3111-AU-003 trial required a platelet count ≥50 x 109/L and an absolute neutrophil count ≥1 x 109/L independent of growth factor support, hepatic enzymes ≤3 x upper limit of normal, total bilirubin ≤1.5 x ULN. Both trials required a CLcr ≥30 mL/min. Both trials excluded patients with prior allogeneic hematopoietic stem cell transplant, exposure to a BTK inhibitor, known infection with HIV, and serologic evidence of active hepatitis B or hepatitis C infection, and patients requiring strong CYP3A inhibitors or strong CYP3A inducers. Patients received BRUKINSA 160 mg twice daily or 320 mg once daily. Among patients receiving BRUKINSA, 79% were exposed for 6 months or longer, and 68% were exposed for greater than one year. Fatal events within 30 days of the last dose of BRUKINSA occurred in 8 (7%) of 118 patients with MCL. Fatal cases included pneumonia in 2 patients and cerebral hemorrhage in one patient. Serious adverse reactions were reported in 36 patients (31%). The most frequent serious adverse reactions that occurred were pneumonia (11%) and hemorrhage (5%). Of the 118 patients with MCL treated with BRUKINSA, 8 (7%) patients discontinued treatment due to adverse reactions in the trials. The most frequent adverse reaction leading to treatment discontinuation was pneumonia (3.4%). One (0.8%) patient experienced an adverse reaction leading to dose reduction (hepatitis B). Table 3 summarizes the adverse reactions in BGB-3111-206 and BGB-3111-AU-003. Table 3: Adverse Reactions (≥10%) in Patients Receiving BRUKINSA in BGB-3111-206 and BGB-3111-AU-003 Trials Body System Adverse Reaction Percent of Patients (N=118) All Grades Grade 3 or % Higher % Infections and infestations Upper respiratory tract infectiona 39 0 Pneumoniab 15 10c Urinary tract infection 11 0.8 Skin and subcutaneous tissue disorders Rashd 36 0 14 0 Bruisinge Gastrointestinal disorders Diarrhea 23 0.8 Constipation 13 0 Vascular disorders Hypertension 12 3.4 Hemorrhagef 11 3.4c Musculoskeletal and connective 14 3.4 Musculoskeletal paing tissue disorders Respiratory, thoracic and Cough 12 0 mediastinal disorders Upper respiratory tract infection includes upper respiratory tract infection, upper respiratory tract infection viral. Pneumonia includes pneumonia, pneumonia fungal, pneumonia cryptococcal, pneumonia streptococcal, atypical pneumonia, lung infection, lower respiratory tract infection, lower respiratory tract infection bacterial, lower respiratory tract infection viral. c Includes fatal adverse reaction. d Rash includes all related terms containing rash. e Bruising includes all related terms containing bruise, bruising, contusion, ecchymosis. f Hemorrhage includes all related terms containing hemorrhage, hematoma. g Musculoskeletal pain includes musculoskeletal pain, musculoskeletal discomfort, myalgia, back pain, arthralgia, arthritis. a
b
Other clinically significant adverse reactions that occurred in <10% of patients with mantle cell lymphoma include major hemorrhage (defined as ≥ Grade 3 hemorrhage or CNS hemorrhage of any grade) (5%), and headache (4.2%). Table 4: Selected Laboratory Abnormalitiesa (>20%) in Patients with MCL in Studies BGB-3111-206 and BGB-3111-AU-003 Laboratory Parameter Percent of Patients (N=118) All Grades (%) Grade 3 or 4 (%) Hematologic abnormalities Neutrophils decreased 45 20 Lymphocytosisb 41 16 Platelets decreased 40 7 Hemoglobin decreased 27 6 Chemistry abnormalities Blood uric acid increased 29 2.6 ALT increased 28 0.9 Bilirubin increased 24 0.9 a b
Based on laboratory measurements. Asymptomatic lymphocytosis is a known effect of BTK inhibition.
Waldenström’s Macroglobulinemia (WM) The safety of BRUKINSA was investigated in two cohorts of Study BGB-3111-302 (ASPEN). Cohort 1 included 199 patients with MYD88 mutation (MYD88MUT) WM, randomized to and treated with either BRUKINSA (101 patients) or ibrutinib (98 patients). The trial also included a non-randomized arm, Cohort 2, with 26 wild type MYD88 (MYD88WT) WM patients and 2 patients with unknown MYD88 status [see Clinical Studies (14.2)]. Among patients who received BRUKINSA, 93% were exposed for 6 months or longer, and 89% were exposed for greater than 1 year. In Cohort 1 of the ASPEN study safety population (N=101), the median age of patients who received BRUKINSA was 70 years (45-87 years old); 67% were male, 86% were White, 4% were Asian and 10% were not reported (unknown race). In Cohort 2 of the ASPEN study safety population (N=28), the median age of patients who received BRUKINSA was 72 (39-87 years old); 50% were male, 96% were White and 4% were not reported (unknown race). In Cohort 1, serious adverse reactions occurred in 44% of patients who received BRUKINSA. Serious adverse reactions in >2% of patients included influenza (3%), pneumonia (4%), neutropenia and neutrophil count decreased (3%), hemorrhage (4%), pyrexia (3%), and febrile neutropenia (3%). In Cohort 2, serious adverse reactions occurred in 39% of patients. Serious adverse reactions in >2 patients included pneumonia (14%).
Permanent discontinuation of BRUKINSA due to an adverse reaction occurred in 2% of patients in Cohort 1 and included hemorrhage (1 patient), neutropenia and neutrophil count decreased (1 patient); in Cohort 2, permanent discontinuation of BRUKINSA due to an adverse reaction occurred in 7% of patients and included subdural hemorrhage (1 patient) and diarrhea (1 patient). Dosage interruptions of BRUKINSA due to an adverse reaction occurred in 32% of patients in Cohort 1 and in 29% in Cohort 2. Adverse reactions which required dosage interruption in >2% of patients included neutropenia, vomiting, hemorrhage, thrombocytopenia, and pneumonia in Cohort 1. Adverse reactions leading to dosage interruption in >2 patients in Cohort 2 included pneumonia and pyrexia. Dose reductions of BRUKINSA due to an adverse reaction occurred in 11% of patients in Cohort 1 and in 7% in Cohort 2. Adverse reactions which required dose reductions in >2% of patients included neutropenia in Cohort 1. Adverse reaction leading to dose reduction occurred in 2 patients in Cohort 2 (each with one event: diarrhea and pneumonia). Table 5 summarizes the adverse reactions in Cohort 1 in ASPEN. Table 5: Adverse Reactions (≥10%) Occurring in Patients with WM Who Received BRUKINSA in Cohort 1 Body System Adverse Reaction BRUKINSA (N=101) Ibrutinib (N=98) All Grades Grade 3 All Grades Grade 3 (%) or 4 (%) (%) or 4 (%) Upper respiratory Infections and infestations 44 0 40 2 a tract infection Pneumoniab 12 4 26 10 Urinary tract infection 11 0 13 2 Gastrointestinal disorders Diarrhea 22 3 34 2 Nausea 18 0 13 1 Constipation 16 0 7 0 Vomiting 12 0 14 1 General disorders 31 1 25 1 Fatiguec Pyrexia 16 4 13 2 Edema peripheral 12 0 20 0 Skin and subcutaneous tissue Bruisingd 20 0 34 0 disorders Rashe 29 0 32 0 Pruritus 11 1 6 0 Musculoskeletal and connective 45 9 39 1 Musculoskeletal painf tissue disorders Nervous system disorders Respiratory, thoracic and mediastinal disorders Vascular disorders
Muscle spasms Headache Dizziness Cough Dyspnea Hemorrhageg Hypertension
10 18 13 16 14 42 14
0 1 1 0 0 4 9
28 14 12 18 7 43 19
1 1 0 0 0 9 14
Upper respiratory tract infection includes upper respiratory tract infection, laryngitis, nasopharyngitis, sinusitis, rhinitis, viral upper respiratory tract infection, pharyngitis, rhinovirus infection, upper respiratory tract congestion. Pneumonia includes lower respiratory tract infection, lung infiltration, pneumonia, pneumonia aspiration, pneumonia viral. Fatigue includes asthenia, fatigue, lethargy. d Bruising includes all related terms containing bruise, contusion, or ecchymosis. e Rash includes all related terms rash, maculo-papular rash, erythema, rash erythematous, drug eruption, dermatitis allergic, dermatitis atopic, rash pruritic, dermatitis, photodermatoses, dermatitis acneiform, stasis dermatitis, vasculitic rash, eyelid rash, urticaria, skin toxicity. f Musculoskeletal pain includes back pain, arthralgia, pain in extremity, musculoskeletal pain, myalgia, bone pain, spinal pain, musculoskeletal chest pain, neck pain, arthritis, musculoskeletal discomfort. g Hemorrhage includes epistaxis, hematuria, conjunctival hemorrhage, hematoma, rectal hemorrhage, periorbital hemorrhage, mouth hemorrhage, post procedural hemorrhage, hemoptysis, skin hemorrhage, hemorrhoidal hemorrhage, ear hemorrhage, eye hemorrhage, hemorrhagic diathesis, periorbital hematoma, subdural hemorrhage, wound hemorrhage, gastric hemorrhage, lower gastrointestinal hemorrhage, spontaneous hematoma, traumatic hematoma, traumatic intracranial hemorrhage, tumor hemorrhage, retinal hemorrhage, hematochezia, diarrhea hemorrhagic, hemorrhage, melena, post-procedural hematoma, subdural hematoma, anal hemorrhage, hemorrhagic disorder, pericardial hemorrhage, postmenopausal hemorrhage, stoma site hemorrhage, subarachnoid hemorrhage. a
b c
Adverse reactions lead to treatment discontinuation in 6% of patients, dose reduction in 2.3%, and dose interruption in 34%. The leading cause of dose modification was respiratory tract infections (13%). Table 7 summarizes selected adverse reactions in BGB-3111-214 and BGB-3111-AU-003. Table 7: Adverse Reactions Occurring in ≥10% Patients with MZL Who Received BRUKINSA Body System Adverse Reaction BRUKINSA (N=88) All Grades Grade 3 (%) or 4 (%) Infections and infestations 26 3.4 Upper respiratory tract infectiona Urinary tract infectionb 11 2.3 Pneumoniac,d 10 6 Gastrointestinal disorders 25 3.4 Diarrheae Abdominal painf 14 2.3 Nausea 13 0 Skin and subcutaneous tissue disorders Bruisingg 24 0 Rashh 21 0 Musculoskeletal and connective 27 1.1 Musculoskeletal paini tissue disorders Vascular disorders General disorders Respiratory, thoracic and mediastinal disorders
a b
Based on laboratory measurements. The denominator used to calculate the rate varied from 86 to 101 based on the number of patients with a baseline value and at least one post-treatment value.
Marginal Zone Lymphoma The safety of BRUKINSA was evaluated in 88 patients with previously treated MZL in two single-arm clinical studies, BGB-3111-214 and BGB-3111-AU-003 [see Clinical Studies (14.3)]. The trials required an absolute neutrophil count ≥1 x 109/L, platelet count ≥50 or ≥75 x 109/L and adequate hepatic function and excluded patients requiring a strong CYP3A inhibitor or inducer. Patients received BRUKINSA 160 mg twice daily (97%) or 320 mg once daily (3%). The median age in both studies combined was 70 years (range: 37 to 95), 52% were male, 64% were Caucasian and 19% were Asian. Most patients (92%) had an ECOG performance status of 0 to 1. Eighty percent received BRUKINSA for 6 months or longer, and 67% received treatment for more than one year. Two fatal adverse reactions (2.3%) occurred within 30 days of the last dose of BRUKINSA, including myocardial infarction and a Covid-19–related death. Serious adverse reactions occurred in 40% of patients. The most frequent serious adverse reactions were pyrexia (8%) and pneumonia (7%).
23 21
1.1 2.3
Coughl
10
0
Upper respiratory tract infection includes upper respiratory tract infection, nasopharyngitis, sinusitis, tonsillitis, rhinitis, viral upper respiratory tract infection. b Urinary tract infection includes urinary tract infection, cystitis, Escherichia urinary tract infection, pyelonephritis, cystitis. c Pneumonia includes COVID-19 pneumonia, pneumonia, bronchopulmonary aspergillosis, lower respiratory tract infection, organizing pneumonia. d Includes 2 fatalities from COVID-19 pneumonia. e Diarrhea includes diarrhea and diarrhea hemorrhagic. f Abdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort. g Bruising includes contusion, ecchymosis, increased tendency to bruise, post procedural contusion. h Rash includes rash, rash maculo-papular, rash pruritic, dermatitis, dermatitis allergic, dermatitis atopic, dermatitis contact, drug reaction with eosinophilia and systemic symptoms, erythema, photosensitivity reaction, rash erythematous, rash papular, seborrheic dermatitis. i Musculoskeletal pain includes back pain, arthralgia, musculoskeletal pain, myalgia, pain in extremity, musculoskeletal chest pain, bone pain, musculoskeletal discomfort, neck pain. j Hemorrhage includes epistaxis, hematuria, hemorrhoidal hemorrhage, hematoma, hemoptysis, conjunctival hemorrhage, diarrhea hemorrhagic, hemorrhage urinary tract, mouth hemorrhage, pulmonary hematoma, subcutaneous hematoma, gingival bleeding, melena, upper gastrointestinal hemorrhage. k Fatigue includes fatigue, lethargy, asthenia. l Cough includes cough and productive cough. a
Clinically relevant adverse reactions in <10% of patients who received BRUKINSA included peripheral neuropathy, second primary malignancies, dizziness, edema, headache, petechiae, purpura, and atrial fibrillation or flutter. Table 8 summarizes select laboratory abnormalities. Table 8: Select Laboratory Abnormalities (≥20%) that Worsened from Baseline in Patients with MZL Laboratory Abnormalitya BRUKINSA Hematologic abnormalities Neutrophils decreased Platelets decreased Lymphocytes decreased Hemoglobin decreased Chemistry abnormalities Glucose increased Creatinine increased Phosphate decreased Calcium decreased ALT increased
Clinically relevant adverse reactions in <10% of patients who received BRUKINSA included localized infection, atrial fibrillation or atrial flutter, and hematuria. Table 6 summarizes the laboratory abnormalities in ASPEN. Table 6: Select Laboratory Abnormalitiesa (≥20%) that Worsened from Baseline in Patients with WM Who Received BRUKINSA in Cohort 1 Laboratory Abnormality BRUKINSAb Ibrutinibb All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Hematologic abnormalities Neutrophils decreased 50 24 34 9 Platelets decreased 35 8 39 5 Hemoglobin decreased 20 7 20 7 Chemistry abnormalities Glucose increased 45 2.3 33 2.3 Creatinine increased 31 1 21 1 Calcium decreased 27 2 26 0 Potassium increased 24 2 12 0 Phosphate decreased 20 3.1 18 0 Urate increased 16 3.2 34 6 Bilirubin increased 12 1 33 1
Hemorrhagej Fatiguek
a
All Grades (%)
Grade 3 or 4 (%)
43 33 32 26
15 10 8 6
54 34 27 23 22
4.6 1.1 2.3 0 1.1
The denominator used to calculate the rate varied from 87 to 88 based on the number of patients with a baseline value and at least one post-treatment value.
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma The safety data described below reflect exposure to BRUKINSA (160 mg twice daily) in 675 patients with CLL from two randomized controlled clinical trials [see Clinical Studies (14.4)]. The trial required patients to be unsuitable for fludarabine, cyclophosphamide, and rituximab (FCR) therapy defined as age ≥65 years, or age 18 to <65 years with either a total Cumulative Illness Rating Scale (CIRS) >6, creatinine clearance 30 to 69 mL/min, or history of serious or frequent infections. The trial excluded patients with AST or ALT ≥2 times the upper limit of normal (ULN) or bilirubin ≥3 times (ULN) and patients requiring a strong CYP3A inhibitor or inducer. SEQUOIA The safety of BRUKINSA monotherapy in patients with previously untreated CLL/SLL was evaluated in a randomized, multicenter, open-label, actively controlled trial [see Clinical Studies (14.4)]. Patients without deletion of chromosome 17p13.1 (17p deletion) (Cohort 1) received either BRUKINSA 160 mg twice daily until disease progression or unacceptable toxicity (n=240) or bendamustine plus rituximab (BR) for 6 cycles (n=227). Bendamustine was dosed at 90 mg/m2/day intravenously on the first 2 days of each cycle, and rituximab was dosed at 375 mg/m2 on day 1 of Cycle 1 and 500 mg/m2 on day 1 of Cycles 2 to 6. Additionally, the same BRUKINSA regimen was evaluated in 111 patients with previously untreated CLL/SLL with 17p deletion in a non-randomized single arm (Cohort 2). Randomized cohort: Previously untreated CLL/SLL without 17p deletion In patients with previously untreated CLL/SLL without 17p deletion, the median age was 70, 62% were male, 89% were White, 2% were Asian, and 2% were Black. Most patients (93%) had an ECOG performance status of 0 to 1. The median duration of exposure to BRUKINSA was 26 months, with 71% exposed for more than 2 years. Serious adverse reactions occurred in 36% of patients who received BRUKINSA. Serious adverse reactions that occurred in ≥5% of patients were COVID-19, pneumonia, and second primary malignancy (5% each). Fatal adverse reactions occurred in 11 (4.6%) patients with the leading cause of death being COVID-19 (2.1%). Adverse reactions led to permanent discontinuation of BRUKINSA in 8% of patients, dose reduction in 8%, and dose interruption in 46%. The most common adverse reactions leading to permanent discontinuation were second primary malignancy and COVID-19. The leading causes of dose modification (≥5% of all patients) were respiratory infections (COVID-19, pneumonia) and hemorrhage.
Table 9 summarizes select adverse reactions in this randomized cohort. Table 9: Adverse Reactions in ≥10% Patients with Previously Untreated CLL/SLL Without 17p Deletion in SEQUOIA CLL/SLL without 17p deletion System Organ Class Preferred Term
BRUKINSA (N=240) All Grades Grade 3 or 4 (%) (%)
BR (N=227) All Grades Grade 3 or 4 (%) (%)
interruption in 51%. The leading causes of dose modification (≥5% of all patients) were pneumonia, neutropenia, second primary malignancy, and diarrhea. Table 11 summarizes select adverse reactions in this cohort. Table 11: Adverse Reactions in ≥10% of Patients with Previously Untreated CLL/SLL and 17p Deletion in SEQUOIA CLL/SLL with 17p Deletion System Organ Class Preferred Term Infections and infestations
Musculoskeletal and connective tissue disorders 33
1.7
17
0.4
Upper respiratory tract infectionb
28
1.3
15
0.9
Pneumoniac
13*
5
8†
4
Hemorrhaged
27*
4
4
0.4
Skin and subcutaneous tissue disorders
Hypertensione
14
7
5
2.6
Musculoskeletal paina Infections and infestations
BRUKINSA (N=111) All Grades Grade 3 or 4 (%) (%)
Upper respiratory tract infectiona
38
0.0
Pneumoniab
20*
8
38
2.7
Rashd
28
0.0
Bruisinge
26
0.9
Musculoskeletal and connective tissue disorders
Vascular disorders
Musculoskeletal painc
Skin and subcutaneous tissue disorders Rashf
24
1.3
30
5
Vascular disorders
Bruisingg
24
0
2.6
0
Hemorrhagef
28
4.5
Hypertensiong
11
5.4
22†
6
Diarrhea
18
0.9
Nausea
16
0.0
Constipation
15
0.0
Abdominal paing
12
1.8
Coughg
18
0.0
Dyspneag
13
0.0
14
0.9
11
1.8
Respiratory, thoracic and mediastinal disorders 15
Coughe
0
10
Neoplasms
0
Second primary malignancyh
Gastrointestinal disorders Diarrhea
14
0.8
12†
0.9
Constipation
10
0.4
18
0.0
Nausea
10
0
33
1.3
Gastrointestinal disorders
General disorders Fatigue
h
14
1.3
21
1.8
13*
6
1.3
0.4
Respiratory, thoracic and mediastinal disorders
Neoplasms Second primary malignancyi Nervous system disorders
General disorders and administration site conditions
Headachee
12
0
8
0
Fatiguei
Dizzinessj
11
0.8
5
0
Nervous system disorders Headache
* Includes 3 fatal outcomes. † Includes 2 fatal outcomes. a Musculoskeletal pain: musculoskeletal pain, arthralgia, back pain, pain in extremity, myalgia, neck pain, spinal pain, musculoskeletal discomfort, bone pain. b Upper respiratory tract infection: upper respiratory tract infection, nasopharyngitis, sinusitis, rhinitis, pharyngitis, upper respiratory tract congestion, laryngitis, tonsillitis and upper respiratory tract inflammation, and related terms. c Pneumonia: pneumonia, COVID-19 pneumonia, lower respiratory tract infection, lung infiltration, and related terms including specific types of infection. d Hemorrhage: all terms containing hematoma, hemorrhage, hemorrhagic, and related terms indicative of bleeding. e Includes multiple similar adverse reaction terms. f Rash: Rash, dermatitis, drug eruption, and related terms. g Bruising: all terms containing bruise, bruising, contusion, or ecchymosis. h Fatigue: fatigue, asthenia, and lethargy i Second primary malignancy: includes non-melanoma skin cancer, malignant solid tumors (including lung, renal, genitourinary, breast, ovarian, and rectal), and chronic myeloid leukemia. j Dizziness: dizziness and vertigo.
* Includes 1 fatal outcome. † Includes non-melanoma skin cancer in 13%. a Upper respiratory tract infection: upper respiratory tract infection, nasopharyngitis, sinusitis, rhinitis, pharyngitis, upper respiratory tract congestion, upper respiratory tract inflammation, viral upper respiratory tract infection, and related terms. b Pneumonia: pneumonia, COVID-19 pneumonia, lower respiratory tract infection, and related terms including specific types of infection. c Musculoskeletal pain: musculoskeletal pain, arthralgia, back pain, pain in extremity, myalgia, neck pain, bone pain. d Rash: Rash, dermatitis, toxic skin eruption, and related terms. e Bruising: all terms containing bruise, bruising, contusion, or ecchymosis. f Hemorrhage: all terms containing hematoma, hemorrhage, hemorrhagic, and related terms indicative of bleeding. g Includes multiple similar adverse reaction terms. h Second primary malignancy: includes non-melanoma skin cancer, malignant solid tumors (including bladder, lung, renal, breast, prostate, ovarian, pelvis, and ureter), and malignant melanoma. i Fatigue: fatigue, asthenia, and lethargy.
Other clinically significant adverse reactions occurring in <10% of BRUKINSA recipients in this cohort included COVID-19 (9%), edema (8%), abdominal pain (8%), urinary tract infection (7%), and atrial fibrillation or flutter (3.3%).
Table 12 summarizes select laboratory abnormalities in this cohort.
Clinically significant adverse reactions occurring in <10% of BRUKINSA recipients in this cohort included urinary tract infection (8%), edema (7%), atrial fibrillation or flutter (4.5%), and COVID-19 (3.6%).
Table 10 summarizes select laboratory abnormalities in this cohort.
Table 12: Select Laboratory Abnormalities (≥20%) that Worsened from Baseline in Patients with Previously Untreated CLL/SLL and 17p Deletion in SEQUOIA
Table 10: Select Laboratory Abnormalities (≥20%) that Worsened from Baseline in Patients with Previously Untreated CLL/SLL without 17p Deletion in SEQUOIA
Laboratory Abnormalitya
Laboratory Abnormalitya Hematologic abnormalities Neutrophils decreased Hemoglobin decreased Platelets decreased Leukocytes increased Chemistry abnormalities Glucose increasedc Creatinine increased Magnesium increased Alanine aminotransferase increased
BRUKINSA BR All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) 37 29 27 21b 55 22 22 21
15 2.5 1.7 21 7 0.8 0 2.1
80 66 61 0.4 67 18 14 23
The denominator used to calculate the rate was 239 in the BRUKINSA arm and 227 in the BR arm, based on the number of patients with a baseline value and at least one post-treatment value. Grading is based on NCI CTCAE criteria. Lymphocytes increased in 15%. c Non-fasting conditions. a
b
Single-arm cohort: Previously untreated CLL/SLL and 17p deletion In 111 patients with previously untreated, 17p del CLL/SLL, the median age was 70, 71% were male, 95% were White, and 1% were Asian. Most patients (87%) had an ECOG performance status of 0 to 1. The median duration of exposure to BRUKINSA was 30 months. Fatal adverse reactions occurred in 3 (2.7%) patients, including pneumonia, renal insufficiency, and aortic dissection (1 patient each). Serious adverse reactions occurred in 41% of patients treated with BRUKINSA. Serious adverse reactions reported in ≥5% of patients were pneumonia (8%) and second primary malignancy (7%). Adverse reactions led to treatment discontinuation in 5% of patients, dose reduction in 5%, and dose
Grade 3 or 4 (%)
Neutrophils decreased
42
19b
Hemoglobin decreased
26
3.6
Platelets decreased
23
0.9 6
Hematologic abnormalities
53 8 11 0.4 10 0.4 0.4 2.2
BRUKINSA All Grades (%)
Chemistry abnormalities Glucose increasedc
52
Magnesium increased
31
0
Creatinine increased
27
0.9
The denominator used to calculate the rate varied from 110 to 111 based on the number of patients with a baseline value and at least one post-treatment value. Grading is based on NCI CTCAE criteria. Grade 4, 9%. c Non-fasting conditions. a
b
ALPINE The safety of BRUKINSA monotherapy was evaluated in patients with previously treated CLL/SLL in a randomized, multicenter, open-label, actively controlled trial [see Clinical Studies (14.4)]. In ALPINE, 324 patients received BRUKINSA monotherapy, 160 mg orally twice daily and 324 patients received ibrutinib monotherapy, 420 mg orally daily until disease progression or unacceptable toxicity. In ALPINE, the median duration of exposure was 24 months for BRUKINSA. Adverse reactions leading to death in the BRUKINSA arm occurred in 24 (7%) patients. Adverse reactions leading to death that occurred in >1% of patients were pneumonia (2.8%) and COVID-19 infection (1.9%). One hundred and four patients in the BRUKINSA arm (32%) reported ≥1 serious adverse reaction. Serious adverse reactions occurring in ≥5% of patients were pneumonia (10%), COVID-19 (7%), and second primary malignancies (5%). Adverse reactions led to treatment discontinuation in 13% of patients, dose reduction in 11%, and dose interruption in 42%. The leading cause of treatment discontinuation was pneumonia. The leading causes of dose modification (≥5% of all patients) were respiratory infections (COVID-19, pneumonia) and neutropenia.
Table 13 summarizes select adverse reactions in ALPINE. Table 13: Adverse Reactions in ≥10% of Patients with Relapsed or Refractory CLL/SLL Who Received BRUKINSA in ALPINE BRUKINSA Ibrutinib (N=324) (N=324) All Grades Grade 3 or 4 All Grades Grade 3 or 4 System Organ Class (%) (%) (%) (%) Preferred Term Infections and infestations Upper respiratory tract infectiona 27 1.2 22 1.2 Pneumoniab 18* 9 19† 11 COVID-19c 14* 7 10† 4.6 Musculoskeletal and connective tissue disorders Musculoskeletal paind 26 0.6 28 0.6 Vascular disorders Hemorrhagee 24* 2.5 26† 3.7 Hypertensionf 19 13 20 13 Skin and subcutaneous tissue disorders Rashg 20 1.2 21 0.9 Bruisingh 16 0.0 14 0.0 Gastrointestinal disorders Diarrhea 14 1.5 22 0.9 General disorders Fatiguei 13 0.9 14 0.9 Respiratory, thoracic and mediastinal disorders Coughf 11 0.3 11 0.0 Nervous system disorders Dizzinessf 10 0.0 7 0.0 * Includes fatal outcomes: pneumonia (9 patients), COVID-19 (8 patients), and hemorrhage (1 patient). † Includes fatal outcomes: pneumonia (10 patients), COVID-19 (9 patients), and hemorrhage (2 patients). a Upper respiratory tract infection: upper respiratory tract infection, sinusitis, pharyngitis, rhinitis, nasopharyngitis, laryngitis, tonsillitis, and related terms. b Pneumonia: Pneumonia, COVID-19 pneumonia, lower respiratory tract infection, lung infiltration, and related terms including specific types of infection. c COVID-19: COVID-19, COVID-19 pneumonia, post-acute COVID-19 syndrome, SARS-CoV-2 test positive. d Musculoskeletal pain: musculoskeletal pain, arthralgia, back pain, pain in extremity, myalgia, neck pain, spinal pain, bone pain, and musculoskeletal discomfort. e Hemorrhage: all terms containing hematoma, hemorrhage, hemorrhagic, and related terms indicative of bleeding. f Includes multiple similar adverse reaction terms. g Rash: Rash, Dermatitis, and related terms. h Bruising: all terms containing bruise, bruising, contusion, or ecchymosis. i Fatigue: asthenia, fatigue, lethargy.
Clinically relevant adverse reactions in <10% of patients who received BRUKINSA included urinary tract infection (9%), supraventricular arrhythmias (9%) including atrial fibrillation or flutter (4.6%), abdominal pain (8%), headache (8%), pruritus (6.2%), constipation (5.9%), and edema (4.6%). Table 14 summarizes select laboratory abnormalities in ALPINE. Table 14: Select Laboratory Abnormalities (≥20%) that Worsened from Baseline in Patients Who Received BRUKINSA in ALPINE Laboratory Abnormality
a
Hematologic abnormalities Neutrophils decreased Hemoglobin decreased Lymphocytes increased Platelets decreased Chemistry abnormalities Glucose increased Creatinine increased Phosphate decreased Calcium decreased a
BRUKINSA Ibrutinib All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) 43 28 24 22
15 4 19 4
33 32 26 24
16 3.7 19 3.4
52 26 21 21
5 0.0 2.5 0.6
29 23 13 29
2.8 0.0 2.2 0.0
The denominator used to calculate the rate was 321 in the BRUKINSA arm, and varied from 320 to 321 in the ibrutinib arm, based on the number of patients with a baseline value and at least one post-treatment value. Grading is based on NCI CTCAE criteria.
7 DRUG INTERACTIONS 7.1 Effect of Other Drugs on BRUKINSA Table 15: Drug Interactions that Affect Zanubrutinib Moderate and Strong CYP3A Inhibitors Clinical • Coadministration with a moderate or strong CYP3A inhibitor increases zanubrutinib Cmax and Impact AUC [see Clinical Pharmacology (12.3)] which may increase the risk of BRUKINSA toxicities. Prevention or management
• Reduce BRUKINSA dosage when coadministered with moderate or strong CYP3A inhibitors [see Dosage and Administration (2.3)].
Moderate and Strong CYP3A Inducers Clinical • Coadministration with a moderate or strong CYP3A inducer decreases zanubrutinib Cmax Impact and AUC [see Clinical Pharmacology (12.3)] which may reduce BRUKINSA efficacy. Prevention or management
• Avoid coadministration of BRUKINSA with strong CYP3A inducers [see Dosage and Administration (2.3)]. • Avoid coadministration of BRUKINSA with moderate CYP3A4 inducers [see Dosage and Administration (2.3)]. If these inducers cannot be avoided, increase BRUKINSA dosage to 320 mg twice daily [see Dosage and Administration (2.3)].
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Based on findings in animals, BRUKINSA can cause fetal harm when administered to pregnant women. There are no available data on BRUKINSA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of zanubrutinib to pregnant rats during the period of organogenesis was associated with fetal heart malformation at approximately 5-fold human exposures (see Data). Women should be advised to avoid pregnancy while taking BRUKINSA. If BRUKINSA is used during pregnancy, or if the patient becomes pregnant while taking BRUKINSA, the patient should be apprised of the potential hazard to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 Embryo-fetal development toxicity studies were conducted in both rats and rabbits. Zanubrutinib was administered orally to pregnant rats during the period of organogenesis at doses of 30, 75, and 150 mg/kg/day. Malformations in the heart (2 or 3-chambered hearts) were noted at all dose levels in the absence of maternal toxicity. The dose of 30 mg/kg/day is approximately 5 times the exposure (AUC) in patients receiving the recommended dose of 160 mg twice daily. Administration of zanubrutinib to pregnant rabbits during the period of organogenesis at 30, 70, and 150 mg/kg/day resulted in post-implantation loss at the highest dose. The dose of 150 mg/kg is approximately 32 times the exposure (AUC) in patients at the recommended dose and was associated with maternal toxicity. In a pre and postnatal developmental toxicity study, zanubrutinib was administered orally to rats at doses of 30, 75, and 150 mg/kg/day from implantation through weaning. The offspring from the middle and high dose groups had decreased body weights preweaning, and all dose groups had adverse ocular findings (e.g., cataract, protruding eye). The dose of 30 mg/kg/day is approximately 5 times the AUC in patients receiving the recommended dose. 8.2 Lactation Risk Summary There are no data on the presence of zanubrutinib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions from BRUKINSA in a breastfed child, advise lactating women not to breastfeed during treatment with BRUKINSA and for two weeks following the last dose. 8.3 Females and Males of Reproductive Potential BRUKINSA can cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations (8.1)]. Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating BRUKINSA therapy. Contraception Females Advise female patients of reproductive potential to use effective contraception during treatment with BRUKINSA and for 1 week following the last dose of BRUKINSA. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus. Males Advise men to avoid fathering a child while receiving BRUKINSA and for 1 week following the last dose of BRUKINSA. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Of the 1550 patients with MCL, MZL, WM, and CLL/SLL in clinical studies with BRUKINSA, 61% were ≥65 years of age, and 22% were ≥75 years of age. Patients ≥65 years of age had numerically higher rates of Grade 3 or higher adverse reactions and serious adverse reactions (63% and 47%, respectively) than patients <65 years of age (57% and 36%, respectively). No overall differences in effectiveness were observed between younger and older patients. 8.6 Renal Impairment No dosage modification is recommended in patients with mild, moderate, or severe renal impairment (CLcr ≥15 mL/min, estimated by Cockcroft-Gault). Monitor for BRUKINSA adverse reactions in patients on dialysis [see Clinical Pharmacology (12.3)]. 8.7 Hepatic Impairment Dosage modification of BRUKINSA is recommended in patients with severe hepatic impairment [see Dosage and Administration (2.2)]. The safety of BRUKINSA has not been evaluated in patients with severe hepatic impairment. No dosage modification is recommended in patients with mild to moderate hepatic impairment. Monitor for BRUKINSA adverse reactions in patients with hepatic impairment [see Clinical Pharmacology (12.3)]. Manufactured for: BeiGene USA, Inc. 1840 Gateway Dr., FL 3 San Mateo, CA 94404 BRUKINSA® is a registered trademark owned by BeiGene, Ltd. or its affiliates. © BeiGene, Ltd. 2023 0721-BRU-PRC-027-r1 1/2023
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