Issuu

Physicians office Resource 2022 | Issue 3

Resources for You, Your Patients, & Your Practice

Financial Considerations Simple Steps for Early Action — PAGE 40

THE IMPORTANCE OF TESTING FOR TRICHOMONAS PAGE 24 MDescapes: NEVIS, A SECRET WORTH SHARING PAGE 28

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

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

1300 BioFire RP2.1-EZ Panel (EUA) Overall 97.1% sensitivity and 99.3% specificity (prospective specimens)4 SARS-CoV-2 98.0% sensitivity and 100% specificity (archived specimens)5 SARS-CoV-2 100% PPA and 100% NPA (contrived specimens)6

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

BFR0001-0517-02

To learn more, visit biofiredx.com

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

CEO Andrew C. Nimmo acnimmo@physiciansofficeresource.com

PRESIDENT John D. Pasquale jpasquale@pharmaconnect.com

Getting the most from this guide

BUSINESS MANAGER Marci J. Hills mhills@physiciansofficeresource.com

TRAVEL EDITOR Brandi L. Brower EDITORIAL BOARD Michael Paquin, FHIMSS Barry Craig, MLT (NCA), CLC STAFF WRITER Dylan J. Chadwick

There are two simple ways to request

CREATIVE DIRECTOR PRODUCTION MANAGER Jessica Elmer

information about the products and services

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

www.PhysiciansOfficeResource.com

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

2022 · ISSUE 3 | 3

TABLE OF CONTENTS

Financial Considerations Unique to U.S. Physicians Simple Steps for Early Action

PAGE 40

THE IMPORTANCE OF TESTING FOR TRICHOMONAS

MDescapes: NEVIS, A SECRET WORTH SHARING

— Estimated global incidence of Trichomonas vaginalis compared to three other curable STIs (Chlamydia trachomatis, Neisseria gonorrhoeae, and syphilis) according to WHO

4 | PHYSICIANS OFFICE RESOURCE

Luxurious Getaways and Special Offers Exclusively for Physicians

— It’s like a secret that nobody knows. You mention in passing that you’ve just been to paradise, and it’s an island called Nevis in the West Indies. Chances are they’ve never heard of it.

Now there’s an easy and effective way to screen for osteoporosis.

Bindex® Fast, accurate and comparable to DXA. Bindex is the world’s first evidence-based, point-of-care osteoporosis diagnostics device that provides results comparable with DXA. Portable, hand-held and lightweight, Bindex scans in seconds and at a fraction of the cost allowing you to quickly provide much-needed osteoporosis diagnostics for your at-risk patients. 1301

NOW YOU CAN TRIAL BINDEX AT NO COST.

To trial Bindex in your office, visit bindex.us/launch or call (970)-306-7452.

PRODUCT FOCUS

BRAIN FUNCTION ASSESSMENT

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

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• Aids in clear diagnosis • Strong Reimbursement • Improves Patient Outcomes • Easy for any staff to perform • Cognitive Testing / Mental Health • Sudomotor Function / Neuropathy • Vestibular Testing / Fall Prevention • Autonomic Function / Cardiovascular Risk

View Brochures, Videos & More at POR.io Enter Number 1302 in the Search Area

EMR Compatable 12 Lead EKG with Interpretation (For iPad, iPhone & other Devices) MOBILE DEVICES!

(PC/Laptop and Mobile Devices sold seperately)

• Latest Technology • Convenient • Affordable • Ultra Portable • User Friendly

EKG for iPad and iPhone

Also works with WINDOWS, MAC, Andorid and tablets

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• Made in USA

For Androids, iPads, iPhones and Tablets!

12 Lead iPhone

Contact us for a special offer: 877.646.3300 // medicaldevicedepot.com © 2015 Nasiff Associates. All rights reserved. CardioSuite, CardioCard, CardioECG, CardioStress, CardioHolter, CardioVitals, CardioMedical Center, CardioCard Mobile and Cardio Universal EMR Interface are trademarks of Nasiff Associates.

6 | PHYSICIANS OFFICE RESOURCE

New iPad EKG

EKG w/ interp.

Manufactured in USA by:

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

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

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Coaxial Ophth, Fiber Optic Oto, Speucla Dispenser, Aneroid BP, Wall Transformer and Wall Board without Thermometer: $979.00 1312 with Thermometer: $1,416.00

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PRODUCT FOCUS

BONE HEALTH WHY BINDEX® IS A GAME-CHANGER IN OSTEOPOROSIS DIAGNOSTICS. 1317

From Bindex Medical 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.

View Brochures, Videos & More at POR.io Enter Number 1317 in the Search Area

CHEMISTRY ANALYZERS EASY, INTEGRATED WITH-PATIENT TESTING I-STAT SYSTEM

Easy, Integrated i-STAT System fr

From Abbott Point of Care The handheld i-STAT System offers a broad menu of diagnostic tests at the patient’s side in just minutes. With just a few drops of blood, the i-STAT System delivers real time, lab-accurate results for a wide range of tests, including chemistries, blood gas, coagulation, cardiac markers, and more. Minimize delays and wasted time with on-side tests. Easy, intuitive operation.

The handheld i-ST patient’s side in ju System delivers re including chemistr Minimize delays a

For intended use and complete product information, visit pointofcare.abbott. For in vitro diagnostic use only. This material is intended for a U.S. audience only. i-STAT is a trademark of Abbott. Physician Office Resource i-STAT Product Description — US 3064.REV1 08/20

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For intended use and

For in vitro diagnostic use i-STAT is a trademark of Ab

View Brochures, Videos & More at POR.io Enter Number 1318 in the Search Area

FULL of COMPLEMENT OFChemistry CLIA-WAIVED Full Complement CLIA-waived Blood Tests ® BLOOD CHEMISTRY PICCOLO Chemistry Analyzer TESTS from Abbott Piccolo Xpress XPRESS® CHEMISTRY ANALYZER

The PiccoloFrom Xpress Chemistry Abbott PointAnalyzer of Care provides physician offices with lab-accurate results for a broad range of CLIA-waived general chemistry The Piccolo Xpress Chemistry Analyzer provides physician tests, including metabolic panels, lipids, liver, and kidney function, and more offices with lab-accurate results for a broad range of CLIA1319with just 100 microliters of chemistry blood. Easy to use, the Piccolo Xpress provides waived general tests, including metabolic panels, lipids, live, andvisit, kidney function, and more with just 100increasing results during a patient’s accelerating treatment decisions, microliters of blood. Easy to use, the PIccolo Xpress provides efficiency, and supporting patient satisfaction. Automated quality control on results during a patient’s visit, accelerating treatment decisions, every test helps ensure accuracy. increasing 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. Piccolo Xpress isView a registered trademark of Abaxis, Inc. and distributed Abbott Point of Care. Brochures, Videos & More atbyPOR.io Physician Office Resource Piccolo Product Description – US 3065.REV1 08/20

Enter Number 1319 in the Search Area

8 | PHYSICIANS OFFICE RESOURCE

POINT OF CARE

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EHENS PR I M

TRANSFORM PATIENT SATISFACTION AND PRACTICE EFFICIENCY.

AVA I L A

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

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

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

PRODUCT FOCUS

CHEMISTRY ANALYZERS

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

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View Brochures, Videos & More at POR.io Enter Number 1322 in the Search Area

ENVOY500+ DELIVERING PROVEN RESULTS IN CLINICAL CHEMISTRY

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

View Brochures, Videos & More at POR.io Enter Number 1323 in the Search Area

COVID-19 TESTING

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WHY COMPROMISE? FAST AND RELIABLE RESULTS ARE NOW DELIVERED AT THE POINT OF CARE. 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.

View Brochures, Videos & More at POR.io Enter Number 1324 in the Search Area

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

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

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

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Advanced Temperature Control & Durable Performance

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

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

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

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

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

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

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

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

Height 83.75 83.75 83.75 83.75

Width 27.5 27.5 55.25 55.25

Depth 31 31 31 31

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

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

Height 83.75 83.75

Width 27.5 55.25

Depth 31 31

Door (1) Stainless (2) Stainless

790*, 3,178.50 5,063.50

Pharma-Lab Refrigerators Accucold ARS23ML ARG23ML ARS49ML ARG49ML

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

Pharma-Lab Freezers Accucold AFS23ML AFS49ML

Capacity 23 cu.ft. 49 cu.ft.

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

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

Refrigerator: Public Vaccine

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

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

Max. Doses

Minimum Cubic Ft.

2,000+ doses

may need more than one refrigerator

1000-2000

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

Private Vaccine

+ ________________

900-1000 801-900

Total doses

= ________________

701-800

17-19.5 cu.ft

Multiply (max inventory) Maximum doses

x 1.25 = ________________

400-700

11-16.7 cu.ft

100-399

4.9-6.1 cu.ft

COVID-19 TESTING PRODUCT FOCUS

BIOFIRE® RESPIRATORY 2.1-EZ (RP2.1-EZ)1 PANEL (EUA)1 From BioFire SARS-CoV-2 is everyone’s top suspect, but many other respiratory bugs can cause similar, overlapping symptoms. In your clinic, you can test for 19 common respiratory pathogens, including SARS- CoV-2, with the BioFire RP2.1-EZ Panel (EUA)1—now available under an FDA Emergency Use Authorization. Syndromic testing means all it takes is one test and just 45 minutes to round up SARS-CoV-2—and all the other usual respiratory suspects. 1. This test is not FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories.

View Brochures, Videos & More at POR.io Enter Number 1326 in the Search Area

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CARESTART™ COVID-19 ANTIGEN TEST

From Mercedes Scientific®

This point-of-care (POC) designated test is one of the top-used amongst our customers. Features/Benefits: • CLIA WAIVED • Results within 15 minutes • Anterior nasal swab specimen collection • Detects SARS-CoV-2 nucleocapsid protein antigen • 87.2% sensitivity and 100% specificity

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This test is not FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories.

View Brochures, Videos & More at POR.io Enter Number 1327 in the Search Area

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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 1328 in the Search Area 12 | PHYSICIANS OFFICE RESOURCE

Why compromise? Immediacy now comes with accuracy.

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LumiraDx’s microfluidic technology provides speed without compromising sensitivity at the point of care.

lumiradx.com The LumiraDx SARS-CoV-2 Ag Test and the LumiraDx SARS-CoV-2 Ab Test have not been cleared or approved by FDA, but have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. The LumiraDx SARS-CoV-2 Ag Test has been authorized only for the detection of SARS-CoV-2 nucleocapsid protein. The LumiraDx SARS-CoV-2 Ab Test has been authorized only for detecting the presence of total antibodies to SARS-CoV-2. They have not been authorized for use to detect any other viruses or pathogens. The emergency use of these Tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic Tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. S-COM-ART 01806 R1

PRODUCT FOCUS

FLU AND RESPIRATORY WHY COMPROMISE? FAST AND RELIABLE RESULTS ARE NOW DELIVERED AT THE POINT OF CARE.

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From LumiraDx

View Brochures, Videos & More at POR.io Enter Number 1330 in the Search Area

BIOFIRE® FILMARRAY® TORCH From BioFire

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

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View Brochures, Videos & More at POR.io Enter Number 1331 in the Search Area

ACUCY INFLUENZA A&B TEST From Sekisui Diagnostics 1332

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.

View Brochures, Videos & More at POR.io Enter Number 1332 in the Search Area

14 | PHYSICIANS OFFICE RESOURCE

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FLU AND RESPIRATORY PRODUCT FOCUS

OSOM ULTRA PLUS FLU A&B TEST From Sekisui Diagnostics 1336

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

View Brochures, Videos & More at POR.io Enter Number 1336 in the Search Area

SOFIA® 2 FLUORESCENT IMMUNOASSAY ANALYZER AND RAPID DIAGNOSTIC TEST KITS

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From Quidel

View Brochures, Videos & More at POR.io Enter Number 1337 in the Search Area

STREP TESTS 1338

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..

View Brochures, Videos & More at POR.io Enter Number 1338 in the Search Area

16 | PHYSICIANS OFFICE RESOURCE

GROW WITH CONFIDENCE

Clinical Systems

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

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• ISE (Ion-Selective Electrode) • remote diagnostics

ENVOY500+ Larger volume • 20-80 patients per day

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Inquire about our

RENTAL PROGRAMS

Selectra Pro M Mid-volume

Call: 888-755-3916

• 10-40 patients per day

infoUS@elitechgroup.com

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Selectra Pro S Compact

www.elitechgroup.com

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

PRODUCT FOCUS

STREP TESTS

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SOFIA® 2 FLUORESCENT IMMUNOASSAY ANALYZER AND RAPID DIAGNOSTIC TEST KITS From Quidel

View Brochures, Videos & More at POR.io Enter Number 1342 in the Search Area

TOXICOLOGY TOXICOLOGY URINE DRUG SCREENING REAGENTS

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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.

View Brochures, Videos & More at POR.io Enter Number 1343 in the Search Area

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.

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18 | PHYSICIANS OFFICE RESOURCE

With complete laboratory solutions from consultation to licensure, and compliance the Abbott Clinical Laboratory Solutions team has you covered.

View Brochures, Videos & More at POR.io Enter Number 1344 in the Search Area

TO X I C O LO G Y S C R E E N I N G

SIMPLIFIED

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Comprehensive toxicology menu now with 14 CLIA1 categorized moderately complex assays.

IMMTOX™ 270 BENCHTOP ANALYZER Toxicology screening solutions for physician offices, treatment centers and laboratories. n

25 assay menu

Up to 270 tests per hour

Compact footprint

Quality products, service and reliability

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

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

For your patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with an FGFR2 fusion or rearrangement

Take in the power of PEMAZYRE PEMAZYRE is the first FDA-approved therapy for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The major efficacy outcomes were evaluated in 107 patients with an FGFR2 fusion or non-fusion rearrangement* in a multicenter, open-label, single-arm study of 146 total patients with locally advanced unresectable or metastatic cholangiocarcinoma who had received ≥1 previous line of systemic therapy.1,†

Patients receiving PEMAZYRE achieved durable responses Median DoR was

9.1 months

Patients with DoR: • ≥6 months: 63% (n=24)

1, ‡

• ≥12 months: 18% (n=7)

Clinical response rates of PEMAZYRE1 100 Percent of Patients

INDICATIONS AND USAGE

FGFR, fibroblast growth factor receptor.

ORR: the primary endpoint2

2.8% CR 33 % PR

36% ORR (95% CI, 27%–45%)

20 0 Efficacy evaluable population (N=107) Note: Data are from IRC per RECIST v1.1, and CR and PR are confirmed.

Median time to response was 2.7 months (range, 0.7–6.9 months)

*Determined by a clinical trial assay performed at a central laboratory. † Patients received PEMAZYRE in 21-day cycles at a dosage of 13.5 mg orally once daily for 14 consecutive days, followed by 7 days off therapy, until disease progression or unacceptable toxicity occurred. The major efficacy outcome measures were ORR and DoR, as determined by IRC according to RECIST v1.1. ‡ 95% CI, 6.0-14.5 months and was calculated using the Brookmeyer and Crowley’s method.1 CI, confidence interval; DoR, duration of response; IRC, independent review committee; ORR, overall response rate; RECIST, Response Evaluation Criteria in Solid Tumors.

Molecular profiling is necessary to detect FGFR2 fusions or rearrangements A next-generation sequencing assay, such as FoundationOne® CDx, meets the following criteria to detect FGFR2 fusions3-6: • Specifically detects FGFR2 fusions (distinct from FGFR2 mutations) • Detects FGFR2 fusions with a wide range of fusion partners (whether known or unknown)

Learn more about testing and treating your appropriate patients. Visit hcp.PEMAZYRE.com

IMPORTANT SAFETY INFORMATION Ocular Toxicity Retinal Pigment Epithelial Detachment (RPED): PEMAZYRE can cause RPED, which may cause symptoms such as blurred vision, visual floaters, or photopsia. Clinical trials of PEMAZYRE did not conduct routine monitoring including optical coherence tomography (OCT) to detect asymptomatic RPED; therefore, the incidence of asymptomatic RPED with PEMAZYRE is unknown.

Among 466 patients who received PEMAZYRE across clinical trials, RPED occurred in 6% of patients, including Grade 3-4 RPED in 0.6%. The median time to first onset of RPED was 62 days. RPED led to dose interruption of PEMAZYRE in 1.7% of patients, and dose reduction and permanent discontinuation in 0.4% and in 0.4% of patients, respectively. RPED resolved continued

Please see Important Safety Information for PEMAZYRE continued on the adjacent page.

IMPORTANT SAFETY INFORMATION (CONTINUED) or improved to Grade 1 levels in 87.5% of patients who required dosage modification of PEMAZYRE for RPED. Perform a comprehensive ophthalmological examination including OCT prior to initiation of PEMAZYRE and every 2 months for the first 6 months and every 3 months thereafter during treatment. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of PEMAZYRE. Modify the dose or permanently discontinue PEMAZYRE as recommended in the prescribing information for PEMAZYRE. Dry Eye: Among 466 patients who received PEMAZYRE across clinical trials, dry eye occurred in 27% of patients, including Grade 3-4 in 0.6% of patients. Treat patients with ocular demulcents as needed.

Hyperphosphatemia and Soft Tissue Mineralization PEMAZYRE can cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcification, calcinosis, and non-uremic calciphylaxis. Increases in phosphate levels are a pharmacodynamic effect of PEMAZYRE. Among 466 patients who received PEMAZYRE across clinical trials, hyperphosphatemia was reported in 92% of patients based on laboratory values above the upper limit of normal. The median time to onset of hyperphosphatemia was 8 days (range 1-169). Phosphate lowering therapy was required in 29% of patients receiving PEMAZYRE. Monitor for hyperphosphatemia and initiate a low phosphate diet when serum phosphate level is >5.5 mg/dL. For serum phosphate levels >7 mg/dL, initiate phosphate lowering therapy and withhold, reduce the dose, or permanently discontinue PEMAZYRE based on duration and severity of hyperphosphatemia as recommended in the prescribing information.

Embryo-Fetal Toxicity Based on findings in an animal study and its mechanism of action, PEMAZYRE can cause fetal harm when administered to a pregnant woman. Oral administration of pemigatinib to pregnant rats during the period of organogenesis caused fetal malformations, fetal growth retardation, and embryo-fetal death at maternal exposures lower than the human exposure based on area under the curve (AUC) at the clinical dose of 13.5 mg. Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose.

Adverse Reactions Serious adverse reactions occurred in 45% of patients receiving PEMAZYRE. Serious adverse reactions in ≥2% of patients who received PEMAZYRE included abdominal pain, pyrexia, cholangitis, pleural effusion, acute kidney injury, cholangitis infective, failure to thrive, hypercalcemia, hyponatremia, small intestinal obstruction, and urinary tract infection. Fatal adverse reactions occurred in 4.1% of patients, including failure to thrive, bile duct obstruction, cholangitis, sepsis, and pleural effusion. Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received PEMAZYRE. Adverse reactions requiring permanent discontinuation in ≥1% of patients included intestinal obstruction and acute kidney injury. Dosage interruptions due to an adverse reaction occurred in 43% of patients who received PEMAZYRE. Adverse reactions requiring dosage interruption in ≥1% of patients included

stomatitis, palmar-plantar erythrodysesthesia syndrome, arthralgia, fatigue, abdominal pain, AST increased, asthenia, pyrexia, ALT increased, cholangitis, small intestinal obstruction, alkaline phosphatase increased, diarrhea, hyperbilirubinemia, electrocardiogram QT prolonged, decreased appetite, dehydration, hypercalcemia, hyperphosphatemia, hypophosphatemia, back pain, pain in extremity, syncope, acute kidney injury, onychomadesis, and hypotension. Dose reductions due to an adverse reaction occurred in 14% of patients who received PEMAZYRE. Adverse reactions requiring dosage reductions in ≥1% of patients who received PEMAZYRE included stomatitis, arthralgia, palmar-plantar erythrodysesthesia syndrome, asthenia, and onychomadesis. Clinically relevant adverse reactions occurring in ≤10% of patients included fractures (2.1%). In all patients treated with pemigatinib, 1.3% experienced pathologic fractures (which included patients with and without cholangiocarcinoma [N=466]). Soft tissue mineralization, including cutaneous calcification, calcinosis, and non-uremic calciphylaxis associated with hyperphosphatemia were observed with PEMAZYRE treatment. Within the first 21-day cycle of PEMAZYRE dosing, serum creatinine increased (mean increase of 0.2 mg/dL) and reached steady state by Day 8, and then decreased during the 7 days off therapy. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed. The most common adverse reactions (incidence ≥20%) were hyperphosphatemia (60%), alopecia (49%), diarrhea (47%), nail toxicity (43%), fatigue (42%), dysgeusia (40%), nausea (40%), constipation (35%), stomatitis (35%), dry eye (35%), dry mouth (34%), decreased appetite (33%), vomiting (27%), arthralgia (25%), abdominal pain (23%), hypophosphatemia (23%), back pain (20%), and dry skin (20%).

Drug Interactions Avoid concomitant use of strong and moderate CYP3A inhibitors with PEMAZYRE. Reduce the dose of PEMAZYRE if concomitant use with a strong or moderate CYP3A inhibitor cannot be avoided. Avoid concomitant use of strong and moderate CYP3A inducers with PEMAZYRE.

Special Populations Advise lactating women not to breastfeed during treatment with PEMAZYRE and for 1 week after the final dose. Reduce the recommended dose of PEMAZYRE for patients with severe renal impairment as described in the prescribing information. Reduce the recommended dose of PEMAZYRE for patients with severe hepatic impairment as described in the prescribing information. Please see the Brief Summary of Prescribing Information on the following pages. References: 1. PEMAZYRE (pemigatinib) Prescribing Information. Incyte Corporation. 2. Abou-Alfa GK, Sahai V, Hollebecque A, et al. Lancet Oncol. 2020;21(5):671-684. 3. Lowery MA, Ptashkin R, Jordan E, et al. Clin Cancer Res. 2018;24(17):4154-4161. 4. Javle MM, Murugesan K, Shroff RT, et al. J Clin Oncol. 2019;37(15 suppl):4087. 5. Hollebecque A, de Bono JS, Plummer R, et al. Ann Oncol. 2019;30(suppl 1):mdz029. 6. Frampton GM, Fichtenholtz A, Otto GA, et al. Nat Biotechnol. 2013;31(11):1023-1031.

BRIEF SUMMARY: For Full Prescribing Information, see package insert. INDICATIONS AND USAGE PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see Dosage and Administration (2.1) in Full Prescribing Information]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) in Full Prescribing Information]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Ocular Toxicity Retinal Pigment Epithelial Detachment (RPED) PEMAZYRE can cause RPED, which may cause symptoms such as blurred vision, visual floaters, or photopsia. Clinical trials of PEMAZYRE did not conduct routine monitoring including optical coherence tomography (OCT) to detect asymptomatic RPED; therefore, the incidence of asymptomatic RPED with PEMAZYRE is unknown. Among 466 patients who received PEMAZYRE across clinical trials, RPED occurred in 6% of patients, including Grade 3-4 RPED in 0.6%. The median time to first onset of RPED was 62 days. RPED led to dose interruption of PEMAZYRE in 1.7% of patients, and dose reduction and permanent discontinuation in 0.4% and in 0.4% of patients, respectively. RPED resolved or improved to Grade 1 levels in 87.5% of patients who required dosage modification of PEMAZYRE for RPED. Perform a comprehensive ophthalmological examination including OCT prior to initiation of PEMAZYRE and every 2 months for the first 6 months and every 3 months thereafter during treatment. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of PEMAZYRE. Modify the dose or permanently discontinue PEMAZYRE as recommended [see Dosage and Administration (2.3) in Full Prescribing Information]. Dry Eye Among 466 patients who received PEMAZYRE across clinical trials, dry eye occurred in 27% of patients, including Grade 3-4 in 0.6% of patients. Treat patients with ocular demulcents as needed. Hyperphosphatemia and Soft Tissue Mineralization PEMAZYRE can cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcification, calcinosis, and non-uremic calciphylaxis. Increases in phosphate levels are a pharmacodynamic effect of PEMAZYRE [see Clinical Pharmacology (12.2) in Full Prescribing Information]. Among 466 patients who received PEMAZYRE across clinical trials, hyperphosphatemia was reported in 92% of patients based on laboratory values above the upper limit of normal. The median time to onset of hyperphosphatemia was 8 days (range 1-169). Phosphate lowering therapy was required in 29% of patients receiving PEMAZYRE. Monitor for hyperphosphatemia and initiate a low phosphate diet when serum phosphate level is > 5.5 mg/dL. For serum phosphate levels > 7 mg/dL, initiate phosphate lowering therapy and withhold, reduce the dose, or permanently discontinue PEMAZYRE based on duration and severity of hyperphosphatemia [see Dosage and Administration (2.3) in Full Prescribing Information]. Embryo-Fetal Toxicity Based on findings in an animal study and its mechanism of action, PEMAZYRE can cause fetal harm when administered to a pregnant woman. Oral administration of pemigatinib to pregnant rats during the period of organogenesis caused fetal malformations, fetal growth retardation, and embryo-fetal death at maternal exposures lower than the human exposure based on area under the curve (AUC) at the clinical dose of 13.5 mg. Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose [see Use in Specific Populations (8.1, 8.3) in Full Prescribing Information]. ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: • Ocular Toxicity [see Warnings and Precautions (5.1) in Full Prescribing Information] • Hyperphosphatemia and Soft Tissue Mineralization [see Warnings and Precautions (5.2) in Full Prescribing Information]. 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 safety of PEMAZYRE was evaluated in FIGHT-202, which included 146 patients with previously treated, locally advanced or metastatic cholangiocarcinoma [see Clinical Studies (14.1) in Full Prescribing Information]. Patients were treated orally with PEMAZYRE 13.5 mg once daily for 14 days on followed by 7 days off therapy until disease progression or unacceptable toxicity. The median duration of

treatment was 181 days (range: 7 to 730 days). The median age of PEMAZYREtreated patients was 59 years (range 26-78), 58% were females, and 71% were White. Serious adverse reactions occurred in 45% of patients receiving PEMAZYRE. Serious adverse reactions in ≥ 2% of patients who received PEMAZYRE included abdominal pain, pyrexia, cholangitis, pleural effusion, acute kidney injury, cholangitis infective, failure to thrive, hypercalcemia, hyponatremia, small intestinal obstruction, and urinary tract infection. Fatal adverse reactions occurred in 4.1% of patients, including failure to thrive, bile duct obstruction, cholangitis, sepsis, and pleural effusion. Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received PEMAZYRE. Adverse reactions requiring permanent discontinuation in ≥ 1% of patients included intestinal obstruction and acute kidney injury. Dosage interruptions due to an adverse reaction occurred in 43% of patients who received PEMAZYRE. Adverse reactions requiring dosage interruption in ≥ 1% of patients included stomatitis, palmar-plantar erythrodysesthesia syndrome, arthralgia, fatigue, abdominal pain, AST increased, asthenia, pyrexia, ALT increased, cholangitis, small intestinal obstruction, alkaline phosphatase increased, diarrhea, hyperbilirubinemia, electrocardiogram QT prolonged, decreased appetite, dehydration, hypercalcemia, hyperphosphatemia, hypophosphatemia, back pain, pain in extremity, syncope, acute kidney injury, onychomadesis, and hypotension. Dose reductions due to an adverse reaction occurred in 14% of patients who received PEMAZYRE. Adverse reactions requiring dosage reductions in ≥ 1% of patients who received PEMAZYRE included stomatitis, arthralgia, palmar-plantar erythrodysesthesia syndrome, asthenia, and onychomadesis. Table 1 summarizes the adverse reactions in FIGHT-202. Table 2 summarizes laboratory abnormalities in FIGHT-202.

Table 1: Adverse Reactions (≥ 15%) in Patients Receiving PEMAZYRE in FIGHT-202 PEMAZYRE N=146 All Gradesa Grades ≥ 3* Adverse Reaction (%) (%) Metabolism and nutrition disorders Hyperphosphatemiab

Decreased appetite

1.4

Hypophosphatemiac

Dehydration

3.4

Skin and subcutaneous tissue disorders Alopecia

Nail toxicityd

2.1

Dry skin

0.7

Palmar-plantar erythrodysesthesia syndrome

4.1

Diarrhea

2.7

Nausea

2.1

Constipation

0.7

Stomatitis

Dry mouth

Vomiting

1.4

Abdominal pain

4.8

Fatigue

4.8

Edema peripheral

0.7

Dysgeusia

Headache

0.7

Gastrointestinal disorders

General disorders

Nervous system disorders

Eye disorders Dry eyee

Musculoskeletal and connective tissue disorders Arthralgia

Back pain

2.7

Pain in extremity

2.1

Table 1 continued above.

Table 1 continued.

Adverse Reaction

PEMAZYRE N=146 All Gradesa Grades ≥ 3* (%) (%)

Infections and infestations Urinary tract infection

2.7

2.1

Investigations Weight loss

*Only Grades 3 – 4 were identified. a Graded per NCI CTCAE 4.03. b Includes hyperphosphatemia and blood phosphorous increased; graded based on clinical severity and medical interventions taken according to the “investigations-other, specify” category in NCI CTCAE v4.03. c Includes hypophosphatemia and blood phosphorous decreased. d Includes nail toxicity, nail disorder, nail discoloration, nail dystrophy, nail hypertrophy, nail ridging, nail infection, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomycosis, and paronychia. e Includes dry eye, keratitis, lacrimation increased, pinguecula, and punctate keratitis.

Clinically relevant adverse reactions occurring in ≤ 10% of patients included fractures (2.1%). In all patients treated with pemigatinib, 1.3% experienced pathologic fractures (which included patients with and without cholangiocarcinoma [N=466]). Soft tissue mineralization, including cutaneous calcification, calcinosis, and non-uremic calciphylaxis associated with hyperphosphatemia were observed with PEMAZYRE treatment.

Table 2: Select Laboratory Abnormalities (≥ 10%) Worsening from Baseline in Patients Receiving PEMAZYRE in FIGHT-202 a PEMAZYRE N=146 Grades ≥ 3 All Gradesb Laboratory Abnormality (%) (%) Hematology Decreased hemoglobin

Decreased lymphocytes

6 8

Decreased platelets

3.4

Increased leukocytes

0.7

Decreased leukocytes

1.4

Chemistry Increased phosphatec

Decreased phosphate

Increased alanine aminotransferase

4.1

Increased aspartate aminotransferase

Increased calcium

4.1

Increased alkaline phosphatase

Increased creatinined

1.4

Decreased sodium

Increased glucose

0.7

Decreased albumin

Increased urate

Increased bilirubin

Decreased potassium

Decreased calcium

2.7

Increased potassium

2.1

Decreased glucose

1.4

The denominator used to calculate the rate varied from 142-146 based on the number of patients with a baseline value and at least one post-treatment value. b Graded per NCI CTCAE 4.03. c Based on CTCAE 5.0 grading. d Graded based on comparison to upper limit of normal. a

Increased Creatinine Within the first 21-day cycle of PEMAZYRE dosing, serum creatinine increased (mean increase of 0.2 mg/dL) and reached steady state by Day 8, and then decreased during the 7 days off therapy. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed [see Clinical Pharmacology (12.3) in Full Prescribing Information]. DRUG INTERACTIONS Effect of Other Drugs on PEMAZYRE Strong and Moderate CYP3A Inducers Concomitant use of PEMAZYRE with a strong or moderate CYP3A inducer decreases pemigatinib plasma concentrations, [see Clinical Pharmacology (12.3) in Full Prescribing Information] which may reduce the efficacy

of PEMAZYRE. Avoid concomitant use of strong and moderate CYP3A inducers with PEMAZYRE. Strong and Moderate CYP3A Inhibitors Concomitant use of a strong or moderate CYP3A inhibitor with PEMAZYRE increases pemigatinib plasma concentrations, [see Clinical Pharmacology (12.3) in Full Prescribing Information] which may increase the incidence and severity of adverse reactions. Avoid concomitant use of strong and moderate CYP3A inhibitors with PEMAZYRE. Reduce PEMAZYRE dosage if concomitant use of strong and moderate CYP3A inhibitors cannot be avoided [see Dosage and Administration (2.4) in Full Prescribing Information]. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary Based on findings in an animal study and its mechanism of action, PEMAZYRE can cause fetal harm or loss of pregnancy when administered to a pregnant woman [see Clinical Pharmacology (12.1) in Full Prescribing Information]. There are no available data on the use of PEMAZYRE in pregnant women. Oral administration of pemigatinib to pregnant rats during the period of organogenesis at maternal plasma exposures below the human exposure at the clinical dose of 13.5 mg resulted in fetal malformations, fetal growth retardation, and embryo-fetal death (see Data). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Once daily oral administration of pemigatinib to pregnant rats during the period of organogenesis resulted in 100% embryofetal mortality due to post-implantation loss at doses ≥ 0.3 mg/kg (approximately 0.6 times the human exposure based on AUC at the clinical dose of 13.5 mg). Fetal survival was unaffected at 0.1 mg/kg per day; however, once daily oral administration of pemigatinib at the 0.1 mg/kg dose level (approximately 0.2 times the human exposure based on AUC at the clinical dose of 13.5 mg) resulted in reduced mean fetal body weight and an increase in fetal skeletal and visceral malformations, major blood vessel variations, and reduced ossification. Lactation Risk Summary There are no data on the presence of pemigatinib or its metabolites in human milk or their effects on either the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children from PEMAZYRE, advise women not to breastfeed during treatment and for 1 week after the final dose. Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiating PEMAZYRE [see Use in Specific Populations (8.1) in Full Prescribing Information]. Contraception PEMAZYRE can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1) in Full Prescribing Information]. Females Advise females of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose. Males Advise males with female partners of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose. Pediatric Use The safety and effectiveness of PEMAZYRE have not been established in pediatric patients. Animal Toxicity Data In 4- or 13-week repeat-dose toxicology studies in rats and non-human primates, animals displayed toxicities in bone and teeth at pemigatinib exposures lower than the human exposure at the clinical dose of 13.5 mg. Physeal and cartilage dysplasia were present in multiple bones in both species, and tooth (incisor) abnormalities (complete loss of ameloblasts with associated secondary changes) occurred in rats. Six weeks after cessation of dosing, these findings did not show complete evidence of recovery, and additional tooth-related findings (mal-aligned, whitened, broken, and trimmed/thinned incisors) developed in the 13-week study. Geriatric Use In FIGHT-202, 32% of patients were 65 years and older, and 8% of patients were 75 years and older. No overall differences in safety or effectiveness were observed between these patients and younger patients. Renal Impairment Reduce the recommended dosage of PEMAZYRE for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2, estimated by Modification of Diet in Renal Disease [MDRD] equation) [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) in Full Prescribing Information]. No dosage adjustment is recommended for patients with mild or moderate renal impairment (eGFR 30 to 89 mL/min/1.73 m2). No dosage adjustment is recommended for patients with end-stage renal disease (eGFR < 15 mL/min/1.73 m2) who are receiving intermittent hemodialysis. [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Hepatic Impairment Reduce the recommended dosage of PEMAZYRE for patients with severe hepatic impairment (total bilirubin > 3 × ULN with any AST) [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3) in Full Prescribing Information]. No dosage adjustment is recommended for patients with mild (total bilirubin > upper limit of normal [ULN] to 1.5 × ULN or AST > ULN) or moderate (total bilirubin >1.5–3 × ULN with any AST) hepatic impairment [see Clinical Pharmacology (12.3) in Full Prescribing Information]. PEMAZYRE is a registered trademark of Incyte Corporation. U.S. Patent Nos. 9,611,267 and 10,131,667 © 2020-2021 Incyte Corporation. All rights reserved. Issued: February 2021 PLR-PEM-00009

FEATURE

US Trichomonas Insights:

The Importance of Testing for Trichomonas Estimated global incidence of Trichomonas vaginalis compared to three other curable STIs (Chlamydia trachomatis, Neisseria gonorrhoeae, and syphilis) according to WHO BY SEKISUI DIAGNOSTICS

Trichomoniasis is a common, curable, non-viral sexually transmitted infection caused by a motile protozoan parasite called Trichomonas vaginalis. Trichomonas (sometimes referred to as “Trich”) infects the vagina and sometimes urethra and is transmitted during unprotected sex. It is roughly as big as a white blood cell, and it is thought to be responsible for approximately 15-20% of symptomatic vaginitis infections. 24 | PHYSICIANS OFFICE RESOURCE

Both men and women can get a Trichomonas infection, but it is more commonly detected in women. Formerly considered a nuisance infection, trichomoniasis is now recognized as a cause of serious health problems. Nevertheless, it continues to be highly underdiagnosed and under-treated.

Incidence The World Health Organization estimates an incidence of 276 million new cases of T vaginalis each year and a prevalence of 187 million infected individuals between the age of 15 and 49 years old. In the United States, the Centers for Disease Control and Prevention estimates that there were more than two million trichomoniasis infections in 2018. The incidence of trichomoniasis in Europe is similar to that in the United States. In Africa, the prevalence of trichomoniasis may be much higher. The prevalence of vaginal T vaginalis infection was estimated to be 11-25% among African study populations. Symptoms Only about 30% develop any symptoms of trichomoniasis. When symptoms do occur, they range from mild irritation to severe inflammation. Some people with symptoms get them within 5 to 28 days after being infected. Others do not develop symptoms until much later, and those symptoms can come and go. It is important to note that people without symptoms can still pass the infection on to others. Trichomonas symptoms in women can be differentiated from other common forms of vaginitis. Men with trichomoniasis may notice: • Itching or irritation inside the penis • Burning after urination or ejaculation • Discharge from the penis

of having an infected uterus and Fallopian tubes. This infection, called pelvic inflammatory disease, can cause belly pain, fever, and perhaps the inability to have children (infertility), a pregnancy outside the uterus (ectopic pregnancy), and chronic pelvic pain. Treatment and Prevention Since it is a STI, the best way to prevent Trichomonas is to have protected sex. Re-infections with Trichomoniasis are also possible. The best way to avoid re-infections is for the patient to avoid having sex for seven days after treatment has been administered. Trichomoniasis is typically treated with the following antibiotics: Tinidazole 500mg x 4 tablets as a single dose or Metronidazole twice a day for 5-7 days.

“A major barrier to sexually transmitted infections (STIs) control and prevention is the unavailability of reliable, low-cost, point-of-care tests (POCTs) which allow diagnosis and treatment in a single visit.” —WHO

Complications Trichomoniasis can be treated with medication but left untreated it can last for months or even years and lead to serious complications. For example, trichomoniasis can cause genital inflammation, which makes it easier to get infected with HIV or to pass the HIV virus on to a sex partner. Pregnant women with trichomoniasis are more likely to have their babies too early (preterm delivery). Also, babies born to infected mothers are more likely to have a low birth weight (less than 5.5 pounds).

Diagnosing trichomoniasis STD testing, including a trichomoniasis test, may be recommended for people with certain risk factors, including sex without a condom, multiple sex partners, or a history of other sexually transmitted diseases. Because the majority of men are asymptomatic carriers, the diagnosis of T vaginalis is usually not made, and the male partner is identified and treated with metronidazole at the same time that the female partner is treated.

A woman with untreated trichomoniasis has a greater chance

A number of testing options are available. Choices are made based on accuracy, timeliness and cost: 2022 · ISSUE 3 | 25

Microscopy • The most commonly used diagnostic test is wet preparation microscopy. • A swab is used to collect material from the vaginal fornix and placed into a small amount, 0.5 to 1.0 ml, of normal saline. • A drop of the saline preparation is placed on a slide and viewed with a microscope with a 40× objective. Culture • Refers to the deliberate growing of cells, especially microorganisms, in a solid or liquid medium (e.g. agar, gelatin), as of bacteria in a Petri dish. • Incubation periods ranging from two to seven days are required to identify T vaginalis in culture. Molecular • Nucleic amplification assay tests (NAATs) are based on rRNA extraction from specimens, followed by transcription-mediated amplification of captured rRNA. • The use of this target provides a natural boost to the limit of detection since 102 to 103 copies exist within each organism. Lateral Flow • Immunochromatographic enzyme assay performed on a capillary flow dipstick device with a vaginal swab specimen, such as the OSOM Trichomonas Test. • The assay relies on a latex-tagged antibody to bind specifically to trichomonas proteins and a secondary capture antibody to bind the complex to the lateral-flow device.

OSOM® Trichomonas test The OSOM Trichomonas rapid test has improved sensitivity, specificity, specimen stability, and compares favorably to 26 | PHYSICIANS OFFICE RESOURCE

“Use of this assay as a point-of-care test for the detection of trichomoniasis in an emergency department has been shown to prevent overtreatment of vaginal infections compared with historical controls before the introduction of the POC test, resulting in good antibiotic stewardship.” —Gaydos et al. 2017 NAATs [nucleic amplification assay tests], with reported sensitivities of 83%–90%. Suitable for Laboratory and Point-of-Care (POC) setting: • Offers 95% agreement with culture and wet mount combined • A test-and-treat approach in one visit • Detects the antigen; does not require live organism • Yields results in 10 minutes or less • Offers objective, easy-to-read two-color results • Is the only CLIA-waived rapid test for the detection of trichomoniasis

Advantages of a Test and Treat Approach

• Prevent spread – Quick diagnosis allows the clinician to provide appropriate and immediate treatment to prevent further spread of Trichomoniasis • Patient compliance – Ensures the patient starts medication immediately • Prevent inappropriate treatment – Accurate diagnosis results in avoidance of syndromic management

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A SECRET WORTH SHARING BY BRANDI NIMMO

IT’S LIKE A SECRET THAT NOBODY KNOWS. You mention in passing that you’ve just been to paradise, and it’s an island called Nevis in the West Indies. Chances are they’ve never heard of it. But when you come across someone who has been, their eyes light up, and there’s an instant exchange of enlightenment as if to say, “I’ve been there, I know what you’re feeling.” All over the world, there are beautiful places, but this corner of it is different. It’s special. It is a feeling you have to experience. It’s a special little secret that needs to be shared with others, not just whispered but shouted from its volcanic peak.

28 | PHYSICIANS OFFICE RESOURCE

That mountain, Nevis Peak, rests 3200 feet high upon the small island’s 36-mile circumference. Thought to be one of the most unspoiled treasures in the Caribbean, this island was once a land of coconut and sugar plantations providing more than 20% of the British Empire’s sugar yield. Recent fame as the birthplace of U.S. founding father Alexander Hamilton, “dropped in the middle of a forgotten spot in the Caribbean in Providence,” lyrics of the famous Broadway musical. This “forgotten spot” is located in the Leeward island chain of the West Indies and part of a two-island country, separated from its more bustling sister island to the northwest, St. Kitts, by a twomile channel called The Narrows. “Two islands, one federation, but two worlds,” according to Alexis Arthorton, Nevis Tourism Authority spokesperson. “Nevis provides real island living,” Arthorton touts, “We rush slowly here...No stoplights, no fast food, no movie theaters.” No buildings taller than palm trees, a place where the number of goats and donkeys rival the number of residents, you feel like you’ve stepped back in time. The demographic is a more mature group who want to live, relax, and be with nature. But for those that want the nightlife, casinos, and St. Kitts’ action, it’s just a 20-minute boat ride to St. Christoff harbor. Two islands, one federation but two very different worlds. Just over 30 years ago, Four Seasons came to this verdant landscape with a vision for the majestic 350 acres set at the base of Nevis Peak down to the emerald Caribbean coastline. A dream was imagined and executed, a gorgeous award-winning luxury resort. The island economy once relied heavily on agriculture

and fishing, sending young graduates off the island to find work. Four Seasons brought new economic life and growth for the Nevisian island and people. The Four Seasons Resort has a dedicated staff proudly comprised of 95 percent Nevisian team members. MacKee France, Director of Guest Experiences, has been a member of the Four Seasons family from day one. He feels the key to the success of this Resort is the people. There is a level of quality in service that guests expect with the brand, and Nevis is no exception to that rule. Some would say that the presumptions of excellence are exceeded because of the quality of people on the island. “The happiness is already installed,” says France, “Our team members come to us 90% ready, with their hearts open to serve. We just need to train them on the final 10%.” Many of the Resort’s return guests are always pleasantly surprised and happy to reunite with the sweet Navisian smiles that have welcomed them over the years, team members still there to share in making new magical memories. The commitment that Four Seasons made to the island years ago continued by the decision to embark on a multi-million dollar enhancement project in 2018. The multi-phase renovations, over several years, are now complete and ready to be enjoyed. A highlight of the revitalized Resort; all 189 guest rooms and suites have been reimagined with a light, clean and fresh décor, with textile touches of island life throughout, like the iconic Nevis ambassador, the green vervet monkey. The design team responsible for the new concept, TAL Design Studios, wanted to maintain the quaint and intimate reputation 2022 · ISSUE 3 | 29

of the island as an untouched tropical destination. TAL Founder Todd-Avery Lenahan said, “...design is not meant to be a complete overhaul but rather the realization of a new vision for the resort that speaks to the modern Four Seasons traveler.” Lenahan assures they succeeded while still preserving the humble charm of the Resort’s small island home. Dotting the hillside along the golf course, Four Seasons Resort has over 50 villas to accommodate any special gathering for larger groups or families. Whether a guest room or suite, villa or estate home, with a mountain view, ocean view, or both, your stay will be extraordinary. The new eateries have chic, fashionable styles and reflect the Caribbean’s soul and spirit. The enhancements extend across all of the Resort’s dining options; guests can enjoy relaxed beachside Caribbean-American fare at On the Dune, soak in coastal Mediterranean cuisine at EsQuilina, or modern Caribbean classics at Mango. Fill up on the flavors at Kastawey, traditional Caribbean BBQ, and stop in for a nightcap at a rum-fuelled Crowned Monkey Bar, which features the bespoke Crowned Monkey Rum, only available at Four Seasons Resort Nevis. The cuisine at all options exceeds the high standard for which the Four Seasons is renowned. One would expect nothing less. Once you have heard about this special secret, you have to discover for yourself if it is true. You fly to St. Kitts Robert Bradshaw Airport (Four Seasons greeters whisk away your luggage, which you don’t see again until you’re in your suite), a quick 30 | PHYSICIANS OFFICE RESOURCE

The island is still special more than three decades later; this paradise has stayed true to the promise of perfection, welcoming global visitors to this island home the moment their feet touch the dock.

shuttle drive to the harbor, and a fun 20-minute boat ride while you enjoy a bottle of Ting or Rum punch. Staff members await your arrival as the water taxi pulls up to the newly renovated and expanded “T” shaped pier. A favorite spot for the sundowners club with low lighting on the perimeter of the 7000 square foot surface and conversational clusters of comfy chairs to watch the many memorable sunsets. It’s here that you feel the tropical breeze in your hair, exhale out all the stress and inhale all the beauty. You’re home. Years ago, when Four Seasons Founder and Chairman Isadore Sharp first stepped foot on the palm tree-lined Pinney’s Beach, it was only a few short years before a new legacy within Four Sea-

sons Hotels and Resorts emerged. At the time, Sharp said of the unique spot, “Nevis was really an unknown; it wasn’t on anyone’s radar screen.” The island is still special more than three decades later; this paradise has stayed true to the promise of perfection, welcoming global visitors to this island home the moment their feet touch the dock. Beyond the dock, there are infinite perfect places in this one perfect paradise to see, play, eat and do: an 18 hole Robert Trent Jones golf course where every hole has a gorgeous view, tennis courts featuring red clay, hard court, astroturf, and top-rated tennis instruction, basketball court, garden games with bocce ball court and over-sized chess and shuffleboards. If you want to unwind by the water, there are three distinct choices of pools; The new signature Limin’ Pool is the centerpiece for the Resort, offering incredible views from the Great House lobby straight out to the Caribbean Sea horizon. The Calypso Pool is next to the ocean, great for families, and features an 83-foot swimming lane and a splash pad for children. The Soca Pool is more private and designed for adults with relaxation as the priority. All have infinity water features, surrounded by new landscaping, comfortable lounging chairs, and attentive pool staff to bring chilled scented towels, water face mistings, and cold drinks as you soak up the sun. Three miles of golden sand stretches along Pinney’s Beach, where bright yellow umbrellas contrast against the blue Caribbean Sea to the west. This moment is what you’ve been dreaming about, laying upon a lounger sipping on a yummy drink as Raheem

offers you a mango popsicle. Or perhaps you’ve opted for one of the adorable beach cabanas for the entire day with a hammock, t.v., wifi, attendants like sweet Nabrisca are there for your every whim. Either option is close to all of the on-property water activities to enjoy. Paddle-boarding, Hobie cat, water-skiing, snorkeling tours, you name it, they have it. Their staff is eager to assist you with any equipment needed to enjoy the beautiful blue. You can stay on top of your fitness goals with the workout equipment, exercise classes, and private training available at the sports pavilion. If pampering is your passion, The Spa is a tropical oasis for massage therapy and salon services. Gorgeous landscaped gardens, volcanic-stone whirlpool, Japanese-inspired cold plunge pool surround colorful little gingerbread-trimmed treatment cottages where mind and body can recharge. Indulge with a signature Nevisian massage; this full-body experience incorporates a locally infused blend of scents, spices, and oils of the Caribbean. Ruthlynn works her magic on your muscles, and the tension evaporates. Throw in a few memorable experiences to round off the adventure. Hot sauce-making class with Four Seasons chef and infamous island figure Llewellyn Clark. A fun culinary lesson and a bottle of your efforts to take home to remember it by. Or maybe a colorful tour of Nevis, exploring the quaint shops of the capital Charlestown, joining local Nevisians on the banks of the 107 degrees Bath Stream, and enjoying health benefits that have thrived in local lore for over two centuries. Hiking Nevis Peak and discovering waterfalls and fauna rejuvenates the soul. It is 2022 · ISSUE 3 | 31

When something is this good, it’s tempting to keep it on the down-low, selfishly save it for yourself.

gaining education on the abundant fruit grown on the island and all of the medicinal benefits of nature’s candy on the Orchard Garden Tour. Experience yummy farm-to-table fare at the very colorful and quaint Paradise, a local haunt situated in the foothills. Every offering by owner Karen Belle pops of freshness, accentuated by the flavor of island spices. Round off the day with a late afternoon golf cart ride, the green monkey tour, spy on their mischievous activities—so many things to experience both on and off Resort that awaken the senses and soothe the soul. Four Seasons Resort Nevis has delivered authentic Caribbean luxury with genuine Nevisian hospitality for the past three decades. It has seen many firsts, including earning the first AAA Five-Diamond Award within the brand. Nevis Resort and Spa remain a crown jewel upon Four Seasons tiara, receiving recognition from Condé Nast Traveler and Forbes, among others. Along with the Resort receiving significant awards, many of its team members have also shared in the spotlight, perhaps no more than selftaught Mixologist Kendie Williams. She has made a name for 32 | PHYSICIANS OFFICE RESOURCE

herself within the bartending world for her creative cocktail creations, named “Caribbean Bartender of the Year” numerous times. In the writings of native son Alexander Hamilton (1727): “I leave them to my Reader, with the old Proverb to accompany them, that the Proof of the Pudding is in eating it.” The proof of this paradise is in the people. The secret sauce is the Nevisians and their limin’ way of life. Their island contentment with their smiling faces is contagious. When something is this good, it’s tempting to keep it on the down-low, selfishly save it for yourself. Or you can choose to spread the love. According to island ikon, MacKee France, there is a superstition attached to the national tree of Nevis, the Royal Poinciana or Flamboyant tree. The islanders call it the Shak Shak tree, and some seeds can be found after you crack open the seedpods that grow following the flowering season. If someone is genuine and gives you seeds from a Shak Shak tree, the belief is that you will have “good luck, goodwill, prosperity, progress, and harmony.” France continues with a condition of the promise, “You must not lose the seeds; you put them in a special place and keep them safe. You can share one of your seeds with someone you care about so that they, too, will have good luck. You should spread the love.” Like the superstitious seeds, shared with genuineness, the news of Nevis needs to be shared. This special place, this secret that nobody knows, isn’t meant to be kept quiet but shouted from Nevis peak for all to hear. Spread the love of this island with others.

FOR THE TREATMENT OF ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS (PSO) WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY, AND ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)1

BACKTO ACTIVE

Give Your Biologic-Experienced Patients Suffering With Joint Pain and Stiffness More Than Just Relief2,3 See how you can help your patients gain control of their psoriatic symptoms with CIMZIA, a different kind of anti-TNF2-4 TNF, tumor necrosis factor.

Scan here to learn more.

IMPORTANT SAFETY INFORMATION Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

CIMZIA has demonstrated safety and efficacy in a pivotal study for adult patients with active psoriatic arthritis1 In psoriatic arthritis patients, the primary efficacy end point at Week 12 in RAPID-PsA was ACR20, with 55% of CIMZIA patients achieving ACR20 at Week 12 vs 24% of placebo patients. Similar results were seen in the 20% of patients with prior biologic experience. RAPID-PsA was a randomized, multicenter, phase 3 trial in patients with PsA. The trial was double-blind and placebo-controlled through week 24 and dose-blind to week 48. Results may vary; every person taking CIMZIA is different and responds differently to therapy. See more at CIMZIAhcp.com.

Please see the adjacent page for Important Safety Information and the following pages for a brief summary of full Prescribing Information, or visit CIMZIAhcp.com.

Indications • CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. • CIMZIA is indicated for the treatment of adults with active psoriatic arthritis.

Important Safety Information CONTRAINDICATIONS CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.

with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. • Do not start CIMZIA during an active infection, including localized infections. • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. • If an infection develops, monitor carefully and initiate appropriate therapy.

MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue CIMZIA if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment

• Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy. • In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients. • In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population. • Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population. • Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types. • Cases of acute and chronic leukemia were reported with TNF blocker use.

HEART FAILURE • Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.

HYPERSENSITIVITY • Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.

HEPATITIS B VIRUS REACTIVATION • Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. • Test patients for HBV infection before initiating treatment with CIMZIA. • Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment. • Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.

NEUROLOGIC REACTIONS • TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.

HEMATOLOGIC REACTIONS • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA. • Consider stopping CIMZIA if significant hematologic abnormalities occur.

DRUG INTERACTIONS • Do not use CIMZIA in combination with other biological DMARDs.

AUTOIMMUNITY • Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS • Patients on CIMZIA should not receive live or liveattenuated vaccines.

ADVERSE REACTIONS • The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the following pages for brief summary of full Prescribing Information, or visit CIMZIAhcp.com. ACR20, American College of Rheumatology criteria for 20% response; PsA, psoriatic arthritis. REFERENCES: 1. CIMZIA® [prescribing information]. Smyrna, GA: UCB, Inc. 2. van der Heijde D, Deodhar A, FitzGerald O, et al. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018;4(1):e000582. 3. Data on file. UCB, Inc.; Smyrna, GA. 4. Gladman D, Fleischmann R, Coteur G, Woltering F, Mease PJ. Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res (Hoboken). 2014;66(7):1085-1092. CIMZIA® is a registered trademark of the UCB Group of Companies. All other trademarks and registered trademarks are the property of their respective holders. ©2022 UCB, Inc., Smyrna, GA 30080. All rights reserved. February, 2022. US-P-CZ-PSO-2100209. Printed in the USA.

should takeforintosevere account bothinfection the risk for severe fungal infectionwer WARNINGS AND PRECAUTIONS BRIEF SUMMARY—CONSULT PACKAGE and should take into accountandboth the risk fungal PROFESSIONAL BRIEF PROFESSIONAL SUMMARY—CONSULT PACKAGE WARNINGS AND PRECAUTIONS and risks of antifungal therapy. Risk (see of Serious Infections (see also Boxed INSERT FOR FULL PRESCRIBING INFORMATION and risksWarning) of antifungal therapy. mo INSERT FOR FULL PRESCRIBING INFORMATION Risk of Serious Infections also Boxed Warning) treated with CIMZIA are at an increased risk for developing Malignancies Patients treated with CIMZIAPatients are at an increased risk for developing ® Malignancies Hy CIMZIA (certolizumab pegol) serious infections involving various organ systems and sites that may ® CIMZIA (certolizumab pegol) the controlled of clinical studies of some TNF blockers, The serious infections involving various organ systems and sites that may In the controlled portions ofInclinical studies ofportions some TNF blockers, lead to hospitalization or death. more cases of malignancies have been observed among patients lead to hospitalization or death. more cases of malignancies have been observed among patients rea Opportunistic infections due to bacterial, mycobacterial, invasive receiving TNF blockers to control patients. During controlled to bacterial, mycobacterial, invasive receiving TNF blockers compared to control patients.compared During controlled to p WARNINGS: Opportunistic infections duefungal, WARNINGS: viral, parasitic, or other opportunistic pathogens including and open-labeled portions of CIMZIA studies of Crohn’s disease and fungal, viral, parasitic, or other opportunistic pathogens including and open-labeled portions of CIMZIA studies of Crohn’s disease and seru aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, other diseases, malignancies (excluding non-melanoma skin cancer) aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, other diseases, malignancies (excluding non-melanoma skin cancer) the SERIOUS INFECTIONS SERIOUS INFECTIONS histoplasmosis, legionellosis, listeriosis, pneumocystosis and were observed at a rate (95% confidence interval) of 0.5 (0.4, 0.7) histoplasmosis, legionellosis, listeriosis, pneumocystosis and Patientsare treated with CIMZIA are at increased were observed at a rate (95% confidence interval) of 0.5 (0.4, 0.7) furt Patients treated with CIMZIA at increased tuberculosis have been reported with TNF blockers. Patients have per 100 patient-years among 4,650 CIMZIA-treated patients versus a tuberculosis per 100 patient-years among 4,650 CIMZIA-treated patients versus a risk for developing serious infections that may have been reported with TNF blockers. Patients have The risk for developing serious infections that may frequently presented with disseminated rather than localized disease. rate of 0.6 (0.1, 1.7) per 100 patient-years among 1,319 placebofrequently presented with disseminated rather than localized disease. rate of 0.6 (0.1, 1.7) per 100 patient-years among 1,319 placeboexp lead to hospitalization or death [see Warnings lead to hospitalization or death [see Warnings treated patients. During CIMZIA studies of psoriasis, malignancies bloc Treatment with CIMZIA shouldwith not be patientspatients. with an During CIMZIA studies of psoriasis, malignancies and Precautions andMost Adverse Reactions]. Mostwith CIMZIA should Treatment not be initiated in patients an initiated intreated and Precautions and Adverse Reactions]. (excluding cancer) were observed correspondingThe active infection, important localized infections. (excluding non-melanoma skin cancer)non-melanoma were observedskin corresponding who developed activewere infection, including clinically importantincluding localizedclinically infections. patients who developedpatients these infections were these infections to an incidence rate of 0.5 (0.2, 1.0) per 100 subject-years amongsyri Patients greater thanwith 65 co-morbid years of age, patients towith anco-morbid incidence rate of 0.5 (0.2, 1.0) per 100 subject-years among taking concomitantsuch immunosuppressants suchgreater as than 65 years Patients of age, patients taking concomitant immunosuppressants as total of 995 subjects whoofreceived CIMZIA. The size of the controlan conditions, and/or patients taking concomitant aimmunosuppressants total of 995 subjects whoareceived CIMZIA. The size the control conditions, and/or patients taking concomitant immunosuppressants methotrexate or corticosteroids. methotrexate or corticosteroids. and limitedportions durationofofthethestudies controlled portions of the studies (e.g. corticosteroids a greater risk of duration ofgroup and limited the controlled (e.g. corticosteroids may be atoramethotrexate) greater risk of may be atgroup He CIMZIA should be discontinued develops or methotrexate) the ability to draw firm conclusions. infection. The risksshould and benefits of treatment should be considered CIMZIA should be discontinued if a patient develops if a patient precludes the ability to drawprecludes firm conclusions. infection. The risks and benefits of treatment be considered Use a serious infection or sepsis. prior to initiating therapy in patients: Malignancies, some fatal, have been reported among children, a serious infection or sepsis. prior to initiating therapy in patients: Malignancies, some fatal, have been reported among children, wit adolescents, and treatment young adults who received treatment with • with chronic or recurrent infection Reported infections include: adolescents, and young adults who received with • with chronic or recurrent infection Reported infections include: TNF-blocking agents (initiation of therapy ≤ 18 years of age), of chro • Active tuberculosis, including reactivation of • who have been exposed to tuberculosis TNF-blocking agents (initiation of therapy ≤ 18 years of age), of • Active tuberculosis, including reactivation of • who have been exposed to tuberculosis which CIMZIA is half a member. half the cases were occ latentwith tuberculosis. Patients with tuberculosis Approximately the casesApproximately were • with ainfection history of an opportunistic infection which CIMZIA is a member.lymphomas, latent tuberculosis. Patients tuberculosis including Hodgkin’s and non-Hodgkin’s lymphoma. The • with a history of an opportunistic have frequently presented with disseminated lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. have frequently presented with disseminated • who have resided or traveled in areas of endemic tuberculosis or The other cases represented a varietyandof different malignancies and rece who have or extrapulmonary disease. be resided or traveled in areas of endemic tuberculosis or The other cases represented a variety of different malignancies or extrapulmonary disease. Patients should be Patients• should endemic mycoses, such as histoplasmosis, coccidioidomycosis, or wh included rare malignancies usually associated with immunosuppression endemic mycoses, such as histoplasmosis, coccidioidomycosis, or included rare malignancies usually associated with immunosuppression tested before for latent tuberculosis tested for latent tuberculosis CIMZIA use before CIMZIA use blastomycosis andusually malignancies not usually blastomycosis and malignancies that are not observedthatin are children and observed in children and HBV and during Treatment for latent infection and during therapy. Treatment fortherapy. latent infection wh adolescents. The malignancies occurred after a median of 30 • that withmay underlying conditions may predispose them to infection adolescents. The malignancies occurred after a median of 30 be initiated • with underlying conditions predispose them tothat infection should be initiated priorshould to CIMZIA use. prior to CIMZIA use. months of therapyMost (range 1thetopatients 84 months). Most of the patients wit months of therapy (range 1 to 84 months). of Tuberculosis • Invasive fungal infections, includingTuberculosis receiving concomitant These cases wereAde • Invasive fungal infections, including were receiving concomitant were immunosuppressants. Theseimmunosuppressants. cases were Cases of orreactivation of tuberculosis or new tuberculosis infections histoplasmosis, coccidioidomycosis,Cases candidiasis, of reactivation of tuberculosis new tuberculosis infections post-marketing andofaresources derived from a variety of sources trea histoplasmosis, coccidioidomycosis, candidiasis, reported post-marketing andreported are derived from a variety have been observed in patients receiving CIMZIA, including patients have been observed in patients receiving CIMZIA, including patients aspergillosis, blastomycosis, and pneumocystosis. including post-marketing registries and spontaneous post-marketing reports. CIMZIAcon is aspergillosis, blastomycosis, and pneumocystosis. including registries and spontaneous reports. CIMZIA is who have previously or concomitantly whoinvasive have previously or concomitantly received treatment for latentreceived treatment for latent Patients or other not indicated Pat Patients with histoplasmosis orwith otherhistoplasmosis invasive not indicatedand for use in pediatric patients.for use in pediatric patients. or active tuberculosis. Reports included cases of pulmonary active tuberculosis. Reports included cases of pulmonary and fungal infections may present withordisseminated, sho the controlled clinical trials fungal infections may present with disseminated, extrapulmonary (i.e., disseminated) tuberculosis. patients for ofInclinical the controlled portions trials of allportions the TNFofblockers, moreof all the TNF blockers, more extrapulmonary (i.e., disseminated) tuberculosis. Evaluate patients for In Evaluate rather than localized and acti casesobserved of lymphoma beenreceiving observedTNF among patients receiving TNF rather than localized disease. Antigen and disease. Antigen riskinfection factors and for latent infection to initiatinghave been casesprior of lymphoma amonghave patients tuberculosis risk factors andtuberculosis test for latent priortest to initiating antibody testing for histoplasmosis may be foll blockers compared to control patients. In controlled studies of CIMZIA antibody testing for histoplasmosis may be CIMZIA and periodically during therapy. blockers compared to control patients. In controlled studies of CIMZIA CIMZIA and periodically during therapy. negative in someinfection. patients with active infection. forinvestigational Crohn’s diseaseuses, andthere otherwas investigational uses, there was one case negative in some patients with active In p for Crohn’s disease and other one case Treatment of latent tuberculosis infection prior to therapy with Empiric anti-fungal therapyinshould Treatment be considered of latentin tuberculosis infection prior to therapy with lymphoma among 2,657 Empiric anti-fungal therapy should be considered among 2,657ofCIMZIA-treated patients andCIMZIA-treated one case of patients and one case ofand TNF-blocking agents the hasrisk beenof shown to reduce ofthelymphoma risk of tuberculosis patients at risk for invasive fungal infections who TNF-blocking agents has been shown to reduce tuberculosis Hodgkin’s lymphoma among 1,319 placebo-treated patients. patients at risk for invasive fungal infections who Hodgkin’s lymphoma among 1,319 placebo-treated patients. trea reactivation duringCIMZIA, therapy.assess Prior to Prior to initiating if initiating CIMZIA, assess if develop In the CIMZIA RA clinicalandtrials and open label) rea develop severe systemic illness.severe systemic illness. reactivation during therapy. treatment for latent tuberculosis is needed; andInconsider an induration the CIMZIA RA clinical trials (placebo-controlled open(placebo-controlled label) treatment for latent tuberculosis is needed; and consider an induration a total ofwere threeobserved cases ofamong lymphoma were observed among 2,367 wh • Bacterial, viral to of 5tuberculin mm or greater tuberculin result,ofeven threeforcases of lymphoma 2,367 • Bacterial, viral and other infections dueand to other infectionsofdue 5 mm or greater a positive skin testa positive result, even for skin testa total patients. is approximately pathogens including Legionella patients previously vaccinated with Bacille Calmette-Guerin patients. This(BCG). is approximately 2-foldThis higher than expected2-fold in thehigher than expected in the mo opportunistic pathogensopportunistic including Legionella patients previously vaccinated with Bacille Calmette-Guerin (BCG). withhighly RA, particularly those with highly Ne and Listeria. general population. Patientsgeneral with RA,population. particularlyPatients those with and Listeria. Consider Consider anti-tuberculosis therapy prioranti-tuberculosis to initiation of therapy CIMZIA prior in to initiation of CIMZIA in active are at a higherof risk for the development of lymphoma. active disease, are at a higher riskdisease, for the development lymphoma. Use patients with a past history of latent or active tuberculosis in whom The risks and benefits of treatment with CIMZIA The risks and benefits of treatment with CIMZIA patients with a past history of latent or active tuberculosis in whom In the CIMZIA PsO clinicalandtrials and open label) ass In the CIMZIA PsO clinical trials (placebo-controlled open(placebo-controlled label) an adequate course of treatment cannot be confirmed, and for should be carefully considered prior to initiating an adequate course of treatment cannot be confirmed, and for should be carefully considered prior to initiating there was one case of Hodgkin’s lymphoma. there was one case of Hodgkin’s lymphoma. sym withtuberculosis a negativebut testhaving for latent therapy with chronic or recurrent patients with a negative testpatients for latent risk tuberculosis but having risk therapy in patients with chronicinorpatients recurrent Rates incannot clinicalbestudies for CIMZIA factorsDespite for tuberculosis Despite previous or concomitant infection. Patients shouldfor be closely monitored for Rates in clinical studies for CIMZIA compared to the cannot rates be compared to the rates dem factors for tuberculosis infection. previous infection. or concomitant infection. Patients should be closely monitored clinical and trialsmay of other TNF blockers and may not predict the rates dem treatment clinical trialshave of other TNFofblockers not predict the rates theand development and symptoms of infection treatment for latent tuberculosis, casesforoflatent activetuberculosis, tuberculosis cases have of activeoftuberculosis the development of signs symptomsofofsigns infection observed when CIMZIA used in a broader patient population. cau in patients patients when who have CIMZIA is used in a broader patient ispopulation. during andCIMZIA, after treatment including occurred in patients treated occurred with CIMZIA. Sometreated patientswith whoCIMZIA. have Someobserved during and after treatment with includingwith CIMZIA, with Crohn’s or r active tuberculosis Patients have redeveloped with Crohn’s diseasePatients that require chronic disease exposurethat to require chronic exposure to the of possible development of tuberculosis patients treated forbeen beeninsuccessfully activesuccessfully tuberculosistreated have for redeveloped the possible development tuberculosis in patients immunosuppressant therapies maygeneral be at higher risk than the generaldiso tuberculosis while being treated with with CIMZIA. Consultation with therapies immunosuppressant may be at higher risk than the who tested negative for latent tuberculosis infection tuberculosis while being treated with CIMZIA. Consultation who tested negative for latent tuberculosis infection population for the development of lymphoma, even in the absence diso physician withofexpertise in theis treatment of tuberculosis population isfor the development of lymphoma, even in the absence prior[see to initiating and with expertise ina the a physician treatment tuberculosis prior to initiating therapy. Warningstherapy. and [see Warnings TNF blocker therapyThe [seepotential Adverserole Reactions]. The potential role in p recommended to aidinitiating in the decision of whetherofinitiating anti- therapy [seeofAdverse TNF blocker Reactions]. Precautions and Adverse Reactions]. recommended to aid in the decision of whether antiPrecautions and Adverse Reactions]. TNF blocker therapy in the development tuberculosis therapy is appropriate for an individual patient. of TNF blocker therapy in theof development of malignancies in adults of malignancies in adultsHe tuberculosis therapy is appropriate for an individual patient. MALIGNANCY is not known. MALIGNANCY is not known. Strongly consider in patients Strongly consider in patients whotuberculosis develop a new infectionwho develop a new infection Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rareRar Lymphoma and other malignancies, some fatal, havetuberculosis Lymphoma and other malignancies, some fatal, have during CIMZIA treatment, especially in patients who have previously or rep Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare during CIMZIA treatment, especially in patients who have previously or been in children patients T-cellaggressive lymphomadisease that hascourse a veryandaggressive disease course andsys is been reported in children andreported adolescent patientsand adolescent to countries with a high orprevalence tuberculosis, or thattype type ofofT-cell lymphoma has aofvery is recently traveled to countriesrecently with a traveled high prevalence of tuberculosis, treated with TNF blockers, of which CIMZIA is a usuallyin patients fatal, have beenwith reported in patients treated with TNF blockers,pan treated with TNF blockers, of which CIMZIA is a had close contacttuberculosis. with a person with usually active tuberculosis. fatal, have been reported treated TNF blockers, who have had close contactwho withhave a person with active member [see Warnings and Precautions]. CIMZIA is including CIMZIA. majority reported TNF blocker cases occurredwith member [see Warnings and Precautions]. CIMZIA is including CIMZIA. The majority of reported TNFThe blocker casesofoccurred Monitoring indicated for use in pediatric patients. adolescent young adultormales with Crohn’s disease or ulcerativeeve Monitoring not indicated for use innot pediatric patients. in adolescent and young adultin males with and Crohn’s disease ulcerative Patients should be closely monitored for the development of signs colitis. had Almost all of these patients Patients should be closely monitored for the development of signs colitis. with AlmostCIMZIA, all of these patients received treatment withhad the received treatment with the Alth and symptoms of infection during and after treatment immunosuppressants azathioprine(6-MP) and/or 6-mercaptopurine (6-MP) and symptoms of infection during and after treatment with CIMZIA, INDICATIONS AND USAGE immunosuppressants and/or 6-mercaptopurine INDICATIONS AND USAGE the development of tuberculosis who tested azathioprine concomitantly a TNF blocker or prior to diagnosis. It is uncertainpat including the development ofincluding tuberculosis in patients who tested in patients CIMZIA indicated for reducing signsdisease and symptoms of Crohn’s disease concomitantly with a TNF blocker at or priorwith to diagnosis. It is atuncertain of, CIMZIA is indicated for reducing signsisand symptoms of Crohn’s negative for latent tuberculosis infection prior to initiating therapy. whether the occurrence of HSTCL is related negative for latent tuberculosis infection prior to initiating therapy. and maintaining clinicalwith response in adult patients with moderately occurrence of HSTCL is related to use of a TNF blocker or a to use of a TNF blocker or aimm and maintaining clinical response in adult patients moderately Tests for latent tuberculosis infection may also bewhether falselythe negative TNF blocker in combination with these other immunosuppressants. The Tests for latent tuberculosis infection may also be falsely negative to have severely disease who have had response to TNF blocker in combination with these other immunosuppressants. The to severely active disease who hadactive an inadequate response to an inadequate while on therapy with CIMZIA. of using awith TNF azathioprine blocker in combination with azathioprine orsug while on therapy with CIMZIA. therapy. CIMZIA isofindicated potential risk of using a TNF potential blocker inrisk combination or bru conventional therapy. CIMZIAconventional is indicated for the treatment adults for the treatment of adults CIMZIA should be discontinued if a patient develops a serious infection 6-MP should be carefully considered. with moderately severly(RA). activeCIMZIA rheumatoid arthritis (RA). CIMZIA CIMZIA should be discontinued if a patient develops a serious infection 6-MP should be carefully considered. of C with moderately to severly active rheumatoid toarthritis or sepsis. A patient who develops a new infection during treatment for thewith treatment of adult patients withor active Cases of acute leukemia have been reported in association sepsis.psoriatic A patient who develops a new infection during treatment abn is indicated for the treatmentisofindicated adult patients active psoriatic Cases of acuteand and chronic leukemia have and beenchronic reported in association with CIMZIA should be closely monitored, undergo a prompt arthritisfor(PsA). CIMZIA isofindicated for the treatment adults with with post-marketing TNF-blocker use inEven RA and other indications. Even withofCIMZIA should be closely monitored, undergo a prompt and arthritis (PsA). CIMZIA is indicated the treatment adults with with post-marketing TNF-blocker use in RA and other indications. complete diagnostic workup appropriate for an immunocompromised Us active ankylosing spondylitis (AS). CIMZIA is indicated for the treatment in the absence of TNF-blocker therapy, patients with RA may be at a complete diagnostic workup appropriate for an immunocompromised active ankylosing spondylitis (AS). CIMZIA is indicated for the treatment in the be absence of TNF-blocker therapy, patients with RA may be at a patient, andtherapy appropriate antimicrobial therapy should initiated. Dru of adults with moderate-to-severe plaque psoriasis (PsO) who are higher risk (approximately 2-fold) than the general population for the patient, and appropriate antimicrobial should be initiated. of adults with moderate-to-severe plaque psoriasis (PsO) who are higher risk (approximately 2-fold) than the general population for the Ser candidates for systemic therapy or phototherapy. CIMZIA is indicated for Invasive Fungal Infections candidates for systemic therapy or phototherapy. CIMZIA is indicated for development of leukemia. development of leukemia. Invasive Fungal Infections of a adults with non-radiographic axial spondyloarthritis with who objective For patients whowhere residemycoses or travelare in regions where mycoses are Melanoma and Merkel cell carcinoma have been reported in adults with active non-radiographic axial active spondyloarthritis with objective For patients reside or travel in regions Melanoma anddevelop Merkel cell carcinoma have been reported in eta signs of inflammation. endemic, invasive fungal infection if they patients treated with TNF blockers, including CIMZIA. Periodic skin signs of inflammation. endemic, invasive fungal infection should be suspected if they should developbe suspected patients treated including CIMZIA. Periodic skin high a serious systemic illness. Appropriate empiric antifungal therapywith TNF blockers, examinations are recommended for all patients, particularly those with CONTRAINDICATIONS a serious systemic illness. Appropriate empiric antifungal therapy are recommended for all patients, particularly those with of T CONTRAINDICATIONS should be considered while a performed. diagnostic workupexaminations is being performed. risk factors for skin cancer. CIMZIA is contraindicated in patients with a history of hypersensitivity should be considered while a diagnostic workup is being risk for skinincancer. of t CIMZIA is contraindicated in patients with a history of hypersensitivity Antigen and antibodymay testing for histoplasmosis mayfactors be negative reaction to certolizumab pegol or to any of the excipients. Reactions Antigen and antibody testing for histoplasmosis be negative in Heart Failure tox reaction to certolizumab pegol or to any of the excipients. Reactions Heart Failure some patients with active infection. have included angioedema, anaphylaxis, serum sickness, and urticaria some patients with active infection. Cases of worsening congestive The have included angioedema, anaphylaxis, serum sickness, and urticaria Cases of worsening congestive heart failure (CHF) and newheart onsetfailure CHF (CHF) and new onset CHF When feasible, the decision to administer empiric antifungal therapy [see Warnings and Precautions]. been reported TNF blockers, including CIMZIA. CIMZIA hasDM When feasible, the decision to administer empiric antifungal therapy [see Warnings and Precautions]. have been reportedwith with TNFhave blockers, includingwith CIMZIA. CIMZIA has in these patients should be made in consultation with a physician been formally in patients with CHF; however, in clinical in these patients should be made in consultation with a physician with not been formally studied innot patients with CHF;studied however, in clinical Au expertise in the and treatment fungal infections in patients CHFworsening with another TNF blocker, worsening expertise in the diagnosis and treatment of diagnosis invasive fungal infectionsof invasive studies in patients with CHFstudies with another TNF with blocker, Trea congestive heart failure (CHF) and increased mortality due to CHF congestive heart failure (CHF) and increased mortality due to CHF and

were observed. patients withdevelops heart failure and suggestive develops symptoms suggestive of a lupus-like syndrome reactions reported in controlled adversefollowing reactions reported inadverse controlled and uncontrolled studies in and uncontrolled studies in symptoms of a lupus-like syndrome following re observed. Exercise caution in patients Exercise with heartcaution failureinand carefully [see Adverse Reactions].treatment with CIMZIA, discontinue treatment with CIMZIA, discontinue treatment [seeCrohn’s Adverse Reactions]. Crohn’s disease diseases, occurring in patients receiving disease and other diseases, occurringandin other patients receiving treatment [see Adverse Reactions]. onitor them carefully [seemonitor Adversethem Reactions]. CIMZIA atdoses dosesinclude: of 400 mg or other doses include: CIMZIA at doses of 400 mg or other Hypersensitivity Reactions Immunizations Immunizations ypersensitivity Reactions and lymphatic system disorders: Anemia, leukopenia, following symptomswith thathypersensitivity could be compatible with hypersensitivity treatedvaccinations, with CIMZIAexcept may receive except for livesystemBlood Blood and lymphatic disorders: Anemia, leukopenia, Patients treated with CIMZIAPatients may receive for livevaccinations, e following symptoms thatThecould be compatible lymphadenopathy, pancytopenia, and thrombophilia. reactions have been reported rarely following CIMZIA vaccines. data are available on the response pancytopenia, lymphadenopathy, and thrombophilia. or live administration attenuated vaccines. orNolive dataattenuated are available on theNoresponse actions have been reported rarely following CIMZIA administration to patients: dyspnea, angioedema, anaphylaxis, rash,or the secondary to live vaccinations or the secondary of infection by live Cardiacarrhythmias, disorders: Angina arrhythmias, atrial fibrillation, live vaccinations transmission of infection bytransmission live patients: angioedema, anaphylaxis, hypotension, rash,dyspnea,to hypotension, Cardiac disorders: Angina pectoris, atrial pectoris, fibrillation, serum sickness, urticaria.occurred Some after of these reactions after failure, hypertensive heart disease, myocardial infarction, vaccines occurred in patients receivingvaccines CIMZIA.in patients receiving CIMZIA. um sickness, and urticaria. Some of theseandreactions cardiac failure, hypertensivecardiac heart disease, myocardial infarction, the firstIfadministration CIMZIA. If such reactions occur, discontinue In a placebo-controlled clinical trial of patients with myocardial ischemia, pericardial rheumatoid e first administration of CIMZIA. such reactionsofoccur, discontinue myocardial ischemia, pericardial effusion, pericarditis, strokeeffusion, and pericarditis, stroke and In a placebo-controlled trial of patients with rheumatoid furtherandadministration of CIMZIAtherapy. and institute appropriate therapy. clinical arthritis, no differenceresponse was detected in antibodytransient responseischemic to ther administration of CIMZIA institute appropriate attack. transient ischemic attack. arthritis, no difference was detected in antibody to There are noCIMZIA data onin the risks of patients who have CIMZIA andwhen placebo groups when Optic the neuritis,Eye disorders: Optic neuritis, retinal hemorrhage, and uveitis. ere are no data on the risks of using patients whousing haveCIMZIA invaccine betweenTNF CIMZIA andvaccine placebobetween treatment groups the treatmentEye disorders: retinal hemorrhage, and uveitis. experiencedreaction a severe hypersensitivity reaction towards another pneumococcal polysaccharide vaccine and influenza vaccine were perienced a severe hypersensitivity towards another TNF General disorders and administration pneumococcal polysaccharide vaccine and influenza vaccine were General disorders and administration site conditions: Bleeding andsite conditions: Bleeding and blocker;is needed in these[see patients caution is needed [see Adverse Reactions]. administered concurrently with CIMZIA. Similar proportions of patients injection site reactions. cker; in these patients caution Adverse Reactions]. administered concurrently with CIMZIA. Similar proportions of patients injection site reactions. needle shield the removable CIMZIA prefilled developed protective levels of anti-vaccine antibodies between CIMZIA e needle shield inside theThe removable cap ofinside the CIMZIA prefilled cap of the developed of anti-vaccine antibodies between CIMZIA Hepatobiliary disorders: contains natural rubber latex which protective may causelevels and disorders: liver enzymes andElevated hepatitis.liver enzymes and hepatitis. placebo treatment groups; however, patientsHepatobiliary receiving CIMZIA and Elevated inge contains a derivativesyringe of natural rubbera derivative latex whichofmay cause and placebo treatment groups; however, patients receiving CIMZIA and an allergic reaction in individuals sensitive to latex. Immune system disorders: Alopecia totalis. concomitant methotrexate had a lower humoral response compared allergic reaction in individuals sensitive to latex. Immune system disorders: Alopecia totalis. concomitant methotrexate had a lower humoral response compared withalone. patients CIMZIA alone. The clinical significance of this Anxiety,Psychiatric Hepatitis B Virus Reactivation disorders:andAnxiety, disorder, and suicide attempt. with patients receiving CIMZIA Thereceiving clinical significance of this Psychiatric disorders: bipolar disorder, suicidebipolar attempt. epatitis B Virus Reactivation is unknown. Use CIMZIA, of TNF blockers, CIMZIA, has been associated and urinary disorders: Nephrotic is unknown. Renal and urinary disorders:Renal Nephrotic syndrome and renal failure.syndrome and renal failure. e of TNF blockers, including has beenincluding associated withB virus reactivation hepatitiswho B virus patients who are Immunosuppression Reproductive and breast th reactivation of hepatitis (HBV) inof patients are (HBV) in Immunosuppression Reproductive system and breast disorders:system Menstrual disorder.disorders: Menstrual disorder. carriers of this HBV virus.reactivation In some instances, HBVTNF reactivation Since TNF and modulates cellular immune onic carriers of this virus.chronic In some instances, Since mediates inflammation andmediates modulatesinflammation cellular immune Skindisorders: and subcutaneous disorders: Dermatitis, erythema Skin and subcutaneous tissue Dermatitis,tissue erythema occurring in conjunction with TNF blocker therapy has been fatal. responses, the possibility exists for TNF blockers, including CIMZIA, responses, the possibility exists for TNF blockers, including CIMZIA, curring in conjunction with TNF blocker therapy has been fatal. nodosum, and urticaria. nodosum, and urticaria. to affect host defenses against infections majorityinofpatients reportsconcomitantly have occurred in patients concomitantly to affect host defenses against infections and malignancies. The and malignancies. The e majority of reports haveTheoccurred Vascular disorders: Vascularanddisorders: vasculitis.Thrombophlebitis, vasculitis. impactonofthe treatment with CIMZIA on theof development course ofThrombophlebitis, other the medications suppress the impact immuneofsystem, treatment with CIMZIA development and course eiving other medicationsreceiving that suppress immune that system, ControlledArthritis Studies with Rheumatoid Arthritis malignancies, as well as active and/or chronic infections, is not fully which may also contribute to HBV reactivation.Test patients for Controlled Studies with Rheumatoid malignancies, as well as active and/or chronic infections, is not fully hich may also contribute to HBV reactivation.Test patients for CIMZIA was studied primarily in placebo-controlled trials and in understood [see Warnings and Precautions and Adverse Reactions]. HBV infection before initiating treatment with CIMZIA. For patients CIMZIA was studied primarily in placebo-controlled trials and in understood [see Warnings and Precautions and Adverse Reactions]. V infection before initiating treatment with CIMZIA. For patients long-term follow-up studies. The data described below reflect the The safety and efficacy of CIMZIA in patients with immunosuppression who test positive for HBV infection, consultation with a physician long-term follow-up studies. The data described below reflect the The safety and efficacy of CIMZIA in patients with immunosuppression ho test positive for HBV infection, consultation with a physician exposure to CIMZIA in 2,367 patients, including 2,030 exposed has not been formally evaluated. with expertise of hepatitis B ishasrecommended. exposure to CIMZIA in 2,367 RA patients, including 2,030RAexposed not been formally evaluated. th expertise in the treatment of hepatitisin Btheis treatment recommended. at least for 6 months, for at least 6 months, 1,663forexposed at least 1,663 one yearexposed and for at least one year and Adequate datasafety are not availableofon the safety or efficacy of equate data are not available on the or efficacy ADVERSE REACTIONSADVERSE REACTIONS for atinleast 2 years; 1,774 in adequate and well-controlled 282 for at least 2 years; and282 1,774 adequate andand well-controlled treatingofpatients whoanti-viral are carriers of HBV anti-viral therapy in The mostwere: serious adverse reactions were: ating patients who are carriers HBV with therapy in withThe most serious adverse reactions placebo-controlled studies. In placebo-controlledstudies. studies,Inthe population had studies, a medianthe population had a median conjunction TNF blocker therapy to prevent HBV reactivation. njunction with TNF blocker therapy towith prevent HBV reactivation. • Serious Infections [see Warnings and Precautions] age of 53 years entry;females, approximately • Serious Infections [see Warnings and Precautions] age of 53 years at entry; approximately 80%at were 93% 80% were females, 93% are carriers of HBV require treatment with CIMZIA • Malignancies [see Warnings and Precautions] tients who are carriers ofPatients HBV andwho require treatment withand CIMZIA werewere Caucasian andfrom all patients were suffering from active rheumatoid • Malignancies [see Warnings and Precautions] were Caucasian and all patients suffering active rheumatoid should be closely monitored for clinical and laboratory signs of • Heart Failure [see Warnings and Precautions)] ould be closely monitored for clinical and laboratory signs of arthritis, with ofa median disease • Heart Failure [see Warnings and Precautions)] arthritis, with a median disease duration 6.2 years. Mostduration patientsof 6.2 years. Most patients activetherapy HBV infection therapy and for several months ive HBV infection throughout and forthroughout several months Clinical Trials Experience the recommended Clinical Trials Experience received the recommended received dose of CIMZIA or higher. dose of CIMZIA or higher. following termination of therapy. lowing termination of therapy. Because clinical are conducted varying and Table 1reported summarizes the reactions Because clinical studies are conducted under studies widely varying and under widely Tablein1clinical summarizes at a rate of at leastreported 3% in at a rate of at least 3% in In patients who discontinue develop HBVCIMZIA reactivation, discontinue conditions, adverse reaction rates observed studiesthe reactions 200 mg every controlledCIMZIA conditions, adversecontrolled reaction rates observed in clinical studies patients who develop HBV reactivation, patients treated with CIMZIApatients 200 mgtreated everywith otherCIMZIA week compared to other week compared to of a drug cannot be directly compared to rates in the clinical studies and initiate effective anti-viral therapy with appropriate supportive formulation), given concomitantly with methotrexate. of a drug cannot be directly compared to rates in the clinical studies d initiate effective anti-viral therapy with appropriate supportive placeboin(saline formulation),placebo given (saline concomitantly with methotrexate. of another drug, and may not predict the rates observed a broader treatment. The safety of resuming TNF blocker therapy after HBV of another drug, and may not predict the rates observed in a broader atment. The safety of resuming TNF blocker therapy after HBV patient population in clinical practice. controlled exercise is not known. caution patientexercise population in clinical practice. activation is controlled is reactivation not known. isTherefore, cautionTherefore, Table 1:Reported Adverseby Reactions when considering resumption of CIMZIA therapy in this situation and trials Table 1: Adverse Reactions ≥3% of Reported by ≥3% of In premarketing of all patient populations combined hen considering resumption of CIMZIA therapy in this situation and In premarketing controlled of all patient controlled populationstrials combined with CIMZIA Treated withPatients CIMZIA Treated Dosed Every Other Dosed Every Other the most(≥common adverse (≥ 8%) werePatients upper respiratory onitor patients closely. monitor patients closely. the most common adverse reactions 8%) were upperreactions respiratory Week duringPeriod Placebo-Controlled Period of Rheumatoid Week during Placebo-Controlled of Rheumatoid infections (18%), rash (9%) and urinary tract infections (8%). Neurologic Reactions infections (18%), rash (9%) and urinary tract infections (8%). eurologic Reactions Arthritis Studies, with Concomitant Methotrexate. Arthritis Studies, with Concomitant Methotrexate. Use of TNF blockers, of which CIMZIA is a member, has been AdverseLeading Reactions Most CommonlyofLeading to Discontinuation of e of TNF blockers, of which CIMZIA is a member, has been Adverse Reactions to Discontinuation rare cases of ofnew onset or exacerbation of clinicalMost Commonly CIMZIA 200 mg sociated with rare cases ofassociated new onsetwith or exacerbation clinical TreatmentTrials in Premarketing Controlled Trials Placebo+ CIMZIAPlacebo+ 200 mg Treatment in system Premarketing Controlled # symptoms and/or radiographic evidence of central nervous MTX EOW + MTX (%) (%) # Reaction Adverse mptoms and/or radiographic evidence of central nervous system The proportion of patients with Crohn’s disease who discontinued MTX EOW + MTX (%) (%) Adverse Reaction The and proportion of patients with Crohn’s disease who discontinued demyelinating disease, including with peripheral N =640 (Preferred N =324 myelinating disease, including multiple sclerosis, and with multiple peripheralsclerosis, treatment duecontrolled to adverseclinical reactions in the controlled clinical studies (Preferred Term) N =640 N =324Term) treatment due to adverse reactions in the studies demyelinating disease, includingExercise Guillain-Barré syndrome. Exercise myelinating disease, including Guillain-Barré syndrome. 8% for CIMZIA andcommon 7% for placebo. was with 8% forpre-existing CIMZIA and 7% was for placebo. The most adverse The most common adverse caution in considering the use of CIMZIA in patients Upper respiratory tract ution in considering the use of CIMZIA in patients with pre-existing reactions leading to the(fordiscontinuation of CIMZIAUpper (for atrespiratory least 2 patients tract reactions leading to the discontinuation of CIMZIA at least 2 patients or recent-onset peripheral nervous system demyelinating infection 2 6 recent-onset central or peripheral nervouscentral systemordemyelinating and with a higher thanpain placebo) infection pain (0.4% 6 2 and with aseizure higher incidence than placebo) wereincidence abdominal (0.4%were abdominal disorders. Rare cases of neurological disorders, including orders. Rare cases of neurological disorders, including seizure CIMZIA, 0.2% placebo), diarrhea (0.4% CIMZIA, 0% placebo), and CIMZIA, placebo), diarrhea (0.4% CIMZIA, 0% placebo), and Headache4 5 neuritis, have and peripheral neuropathy have 0.2% been reported Headache 5 4 order, optic neuritis, and disorder, peripheraloptic neuropathy been reported obstruction intestinal obstruction (0.4% intestinal CIMZIA, 0% placebo).(0.4% CIMZIA, 0% placebo). in patients treatedReactions]. with CIMZIA [see Adverse Reactions]. patients treated with CIMZIA [see Adverse Hypertension 2 5 Therheumatoid proportion arthritis of patients rheumatoid arthritisHypertension who discontinued 2 5 The proportion of patients with whowith discontinued Hematological Reactions treatment due to adverse reactions in the controlled clinical studies ematological Reactions treatmenthave due tobeen adverse reactions in the controlled clinical studies Nasopharyngitis 5 Rare reportsaplastic of pancytopenia, including Nasopharyngitis 1 5 1 for CIMZIA and 2.5% for placebo. re reports of pancytopenia, including anemia, have beenaplastic anemia,for CIMZIA and 2.5%wasfor5% placebo. The most common adverse The most common adverse TNF blockers. Adverse reactions ofwasthe5%hematologic reactions leading to discontinuation of CIMZIA were tuberculosis Back pain 1 4 ported with TNF blockers.reported Adversewith reactions of the hematologic leading to discontinuation of CIMZIA were tuberculosis Back pain 1 4 including medically significant cytopeniareactions (e.g., leukopenia, infections (0.5%); and pyrexia, urticaria, pneumonia, and rash (0.3%). stem, including medicallysystem, significant cytopenia (e.g., leukopenia, infections (0.5%); and pyrexia, urticaria, pneumonia, and rash (0.3%). pancytopenia, thrombocytopenia) have been infrequently reported Pyrexia 2 3 ncytopenia, thrombocytopenia) have been infrequently reported Pyrexia 3 2 Controlled Studies with Crohn’s Disease Controlled Studies with Crohn’s Disease with CIMZIAThe [seecausal Adverse Reactions]. The causal relationship of these th CIMZIA [see Adverse Reactions]. relationship of these The data described below reflect exposure to CIMZIA at 400 mg Pharyngitis 1 3 The data described below reflect exposure to CIMZIA at 400 mg events to CIMZIA remains unclear. Pharyngitis 1 3 ents to CIMZIA remains unclear. subcutaneous in studies of patients subcutaneous dosing in studies of patientsdosing with Crohn’s disease. In with Crohn’s disease. In Although no high risk group has been identified, exercise caution in Rash 1 3 hough no high risk group has been identified, exercise caution in the safety population studies, a total of 620 patients Rash 3 1 the safety studies, a totalinofcontrolled 620 patients beinghave treated with CIMZIA who have ongoing, or population a history in controlled tients being treated with patients CIMZIA who ongoing, or a history withCIMZIA Crohn’s CIMZIA at a dose of 400 mg, and 614 with Crohn’s disease received at adisease dose ofreceived 400 mg, and 614 Acute bronchitis 1 3 of, significant hematologic abnormalities. Advise all patients to seek Acute bronchitis 1 3 significant hematologic abnormalities. Advise all patients to seek subjects received placebo (including subjects randomized to placebo subjects received placebo (including subjects randomized to placebo medicalsigns attention if they develop signs and symptoms mediate medical attentionimmediate if they develop and symptoms in Study CD2 following open label dosing of CIMZIA at Weeks 0, 2, Fatigue 2 3 Study CD2fever, following open label dosing of CIMZIA at Weeks 0, 2, Fatigue 3 2 suggestive of blood infection (e.g.,inpersistent ggestive of blood dyscrasias or infection (e.g.,dyscrasias persistentorfever, 4). In controlled and uncontrolled studies, 1,564 patients received 4). In discontinuation controlled and uncontrolled studies, 1,564 patients received # bruising, bleeding,Consider pallor) while on CIMZIA. Consider EOW = Every other Week, MTX = Methotrexate. # uising, bleeding, pallor) while on CIMZIA. discontinuation CIMZIA at some dose level, of whom 1,350 patients received 400 EOW = Every other Week, MTX = Methotrexate. CIMZIA athematologic some dose level, of whom 1,350 patients received 400 CIMZIA therapysignificant in patientshematologic with confirmed significant CIMZIA therapy in patientsof with confirmed mg CIMZIA. Approximately 55%45% of subjects mg CIMZIA. Approximately 55% of subjects were female, were were female, 45% were Hypertensive adverse reactions were observed more frequently in abnormalities. Hypertensive adverse normalities. male, The andmajority 94% were Caucasian. Theactive majority of patients in the activereactions were observed more frequently in male, and 94% were Caucasian. of patients in the patients receiving CIMZIA thanreactions in controls. These adverse reactions in controls. These adverse group were Use with BiologicalAntirheumatic Disease-Modifying Antirheumatic group were between the ages of 18 andbetween 64. the ages of 18 and 64. patients receiving CIMZIA than se with Biological Disease-Modifying occurred more with frequently among patients occurred more frequently among patients a baseline history of with a baseline history of Drugs (Biological DMARDs) During controlled clinical studies, the proportion of patients with ugs (Biological DMARDs) hypertension andconcomitant among patients receiving concomitant corticosteroids During controlleduseclinical studies, the proportion of patients with hypertension and among patients receiving corticosteroids Serious infections were seen in clinical studies with concurrent serious adverse reactions was 10% for CIMZIA and 9% for placebo. rious infections were seen in clinical studies with concurrent use and non-steroidal serious TNF adverse reactions was 10% for CIMZIA and 9% for placebo. anti-inflammatory drugs. anti-inflammatory drugs. anakinra (anandinterleukin-1 blocker, The most (occurring common adverse (occurringand in ≥non-steroidal 5% of CIMZIAanakinra (an interleukin-1ofantagonist) another TNFantagonist) blocker, and another The most common adverse reactions in ≥ 5%reactions of CIMZIAPatients receiving CIMZIAevery 4004mg as monotherapy every 4 weeks in etanercept, with no added benefit compared to etanercept alone. A Patients receiving CIMZIA 400 mg as monotherapy weeks in treated patients, and with a higher incidence compared to placebo) anercept, with no added benefit compared to etanercept alone. A treated patients, and with a higher incidence compared to placebo) rheumatoid arthritis controlled clinical trials had similar adverse reactions higher risk of serious infections was also observed in combination use rheumatoid arthritis controlled clinical trials had similar adverse reactions in controlled clinical studies with CIMZIA were upper respiratory her risk of serious infections was also observed in combination use in controlled clinical studies with CIMZIA were upper respiratory to those patients receiving CIMZIA 200 mg every other week. of TNF withBecause abatacept rituximab. Because of the nature infections (e.g. nasopharyngitis, laryngitis, viraltoinfection) those patients in 20%receiving of CIMZIA 200 mg every other week. TNF blockers with abatacept andblockers rituximab. of and the nature infections (e.g. nasopharyngitis, laryngitis, viral infection) in 20% of of the adverse events seen with this combination therapy, similar patients and 13% ofurinary placebo-treated the adverse events seen with this combination therapy, similar Otherpatients, Adverseurinary Reactions Other Adverse Reactions patients andCIMZIA-treated 13% of placebo-treated patients, toxicities also result fromcombination. the use of CIMZIACIMZIA-treated in this combination. Other infrequent reactions in less than 3% of RA tract infections (e.g. bladder infection, bacteriuria, cystitis) in 7%adverse of reactions xicities may also result from the usemay of CIMZIA in this Other infrequent (occurringadverse in less than 3% of(occurring RA tract infections (e.g. bladder infection, bacteriuria, cystitis) in 7% of the usewith of CIMZIA in combination with other biological patients) similar to those seen in Crohn’s disease patients. CIMZIA-treated patients andpatients, in 6% ofandplacebo-treated patients, and to those erefore, the use of CIMZIATherefore, in combination other biological patients) were similar seen inwere Crohn’s disease patients. CIMZIA-treated patients and in 6% of placebo-treated DMARDs is notInteractions]. recommended [see Drug Interactions]. MARDs is not recommended [see Drug Psoriatic Arthritis Clinical Study arthralgia (6% CIMZIA, 4% arthralgia placebo). (6% CIMZIA, 4% placebo). Psoriatic Arthritis Clinical Study Autoimmunity has been in 409 patients Other Adverse Reactions utoimmunity CIMZIA has been studied in CIMZIA 409 patients withstudied psoriatic arthritis (PsA)with psoriatic arthritis (PsA) Other Adverse Reactions CIMZIA ofmay result in the formation of autoantibodies trial. Thewith safety Theadverse most commonly occurring adverse reactionsininacontrolled trials trial.inThea placebo-controlled atment with CIMZIA may Treatment result in thewith formation autoantibodies placebo-controlled safety profile for patients PsAprofile for patients with PsA The most commonly occurring reactions in controlled trials and,ofrarely, in the syndrome. developmentIf of a lupus-like syndrome. If a patient of Crohn’s disease described above. Other serious or significant d, rarely, in the development a lupus-like a patient of Crohn’s disease were described above. Otherwere serious or significant

antibody) positivity in an assay may be influenced positivity neutralizing in an assay may be influenced AdverseAcross Reactions of Special Interest Across(including Indicationsneutralizing antibody)(including treated with CIMZIA was similartreated to the with safetyCIMZIA profilewas seensimilar in patients to the safety Adverse profileReactions seen in patients of Special Interest Indications worse several factorssample including assay methodology, sample handling, and l by several factors including assaybymethodology, handling, with RA and previous experiencewith withRACIMZIA. and previous experience with CIMZIA. Infections Infections timing ofmedications, sample collection, concomitant medications, and underlyinguse o of sample collection, and underlying The incidence in controlled in Crohn’s disease was concomitant The incidence of infections in controlled studiesofininfections Crohn’s disease was studiestiming Ankylosing Spondylitis ClinicalAnkylosing Study Spondylitis Clinical Study disease. ofForthethese reasons, comparisontoof the incidence of antibodies to For thesepatients. reasons, comparison incidence of antibodies for CIMZIA-treated patients and 30% fordisease. placebo-treated CIMZIA-treated ofpatients38% and 30% for placebo-treated patients. Immu CIMZIA has been studied in 325CIMZIA patientshaswith been axialstudied spondyloarthritis in 325 patients of with38% axialforspondyloarthritis pegolwith in the described certolizumab pegol(20% in the studiescertolizumab described below thestudies incidence of below with the incidence of infections consistedinfections primarily(20% of upper respiratory infections infections consisted primarilyThe of upper respiratory whom the majority had ankylosing whom spondylitis the majority (AS) had in a ankylosing placebo-controlled spondylitisThe(AS) in a placebo-controlled Neop in other or to other products may be misleading. in other studies other products maystudies be misleading. for incidence CIMZIA, 13% for placebo). incidence antibodies of serious infections duringor to antibodies CIMZIA, of serious infectionsTheduring study (AS-1). The safety profile study treated(AS-1). with CIMZIA The safety was profile similar treated to the with for CIMZIA was13% similarfortoplacebo). the The polyp clinical studies was 3% per patient-year for CIMZIA-treated the controlled clinical studies wasthe3%controlled per patient-year for CIMZIA-treated Patients Crohn’s time disease werefortested at multiple time points forthe sk Patients with Crohn’s disease were testedwith at multiple points safety profile seen in patients with safety RA. profile seen in patients with RA. patients and 1% for placebo-treated patients.antibodies Serious infections observed patients and 1% for placebo-treated patients. Serious infections observed to certolizumab pegolInduring to certolizumab pegolantibodies during Studies CD1 and CD2. patientsStudies CD1 and CD2. In patient Non-radiographic Axial Spondyloarthritis Non-radiographic ClinicalAxial StudySpondyloarthritis Clinical DRU included bacterial and infections, pneumonia, and pyelonephritis. includedStudy bacterial and viral infections, pneumonia, andviral pyelonephritis. exposed toofCIMZIA, overall percentage of patients who continuously exposed to CIMZIA,continuously the overall percentage patientsthewho CIMZIA has been studied in 317CIMZIA patients haswith beennon-radiographic studied in 317 axial patients with non-radiographic axial to CIMZIA were antibody on atantibody least onepositive occasion was 8%;on at least one occasion was 8%; Use The incidence of new clinical cases ofstudies infections clinicalpositive studies to in CIMZIAwere The incidence of new cases of infections in controlled in in controlled spondyloarthritis (nr-axSpA-1). spondyloarthritis The safety profile(nr-axSpA-1). for patients with The safety profile for patients approximately were neutralizing 6% were neutralizing in vitro. No6%apparent correlation in vitro. No apparent correlationNata rheumatoid arthritis 0.91 per patient-yearapproximately for all CIMZIA-treated rheumatoid arthritiswith was 0.91 per patient-year for allwas CIMZIA-treated nr-axSpA treated with CIMZIA was nr-axSpA similartreated to the with safetyCIMZIA profilewas seensimilar in topatients the safety seenpatient-year in patients of antibody development adverse events or efficacy was observed.An in of antibodypatients. development events or efficacy wastoobserved. and 0.72 per patients. patient-year The to adverse andprofile 0.72 per for placebo-treated Thefor placebo-treated patients with RA and previous experience patients with withRACIMZIA. and previous experience with CIMZIA. oth treated with concomitant had a lowerofrate Patients withherpes concomitantPatients immunosuppressants had a lowerimmunosuppressants rate infections consistedtract primarily of upper tracttreated infections, infections consisted primarily of upper respiratory infections, herpesrespiratory abata Plaque Psoriasis Clinical StudiesPlaque Psoriasis Clinical Studies of antibody development than patients not taking immunosuppressants of antibodytract development not taking immunosuppressants tract infections, and lower respiratory infections.than patients infections, urinary tract infections,infections, and lowerurinary respiratory tract infections. not b In clinical studies, a total of 1112 In clinical subjectsstudies, with plaque a totalpsoriasis of 1112were subjects with psoriasis were arthritis at baselineThe(3% and 11%, respectively). baseline following adverse events The following adverse events In thestudies, controlled studies, atthere were (3% moreand new11%, casesrespectively). In theplaque controlled rheumatoid thererheumatoid were morearthritis new cases the treated with CIMZIA. Of these, treated 779 subjects with CIMZIA. were exposed Of these, for779 at least subjectsofwere exposed foradverse at leastreactions reported Crohn’s disease patients were reported Crohn’s diseasewere patients who inwere antibody-positive (N who were antibody-positiveof (N of serious treatmentin groups, serious infection in theinfection CIMZIA adverse treatmentreactions groups,in the CIMZIA thera 12 months, 551 for 18 months, 12and months, 66 for551 24 for months. 18 months, and 66 forcompared 24 months. at an incidenceto atantibody-negative least 3% higher compared to antibody-negativ = 100) at an higher compared the placeboforgroups (0.06 per patient-year for incidence all CIMZIAat least =3%100) to the placebo groupscompared (0.06 pertopatient-year all CIMZIA patients (N = 1,242): abdominal pain, arthralgia, edema peripheral,comb = 1,242): abdominal pain, arthralgia, edema peripheral, vs. 0.02Rates per patient-year for placebo).patients Rates of(Nserious infections doses vs. 0.02 perand patient-year for placebo). of serious infections Data from three placebo-controlled Datastudies from (Studies three placebo-controlled PS-1, PS-2, andstudies PS-3) (Studies PS-1, PS-2, PS-3) doses nodosum, erythema, injection site pain, paineffica in injection siteerythema erythema, injectioninjection site pain,sitepain in the 200 every0.06 otherperweek dose grouperythema were 0.06nodosum, per patient-year the 200 everywere other weekindose groupmgwere patient-year in 1020 subjects (mean age 46inyears, 102066% subjects males, (mean 94%age white) 46 years, were 66%inmales, 94%mgwhite) comb and upper respiratory tract infection. andper upper respiratoryextremity, tract infection. anddose in thegroup 400were mg every dose groupextremity, were 0.04 patientin the 400 mg every 4 weeks 0.044perweeks patientpooled to evaluate the safety ofpooled CIMZIAto[see evaluate ClinicaltheStudies safety(14)]. of CIMZIA [seeand Clinical Studies (14)]. recom Serious pneumonia, infections included tuberculosis, cellulitis, tuberculosis, cellulitis, and long-term (up to 7Crohn’s years ofdisease exposure), open-label Crohn’s disease Inpneumonia, two long-term (up toand 7 years Inof two exposure), open-label Placebo-Controlled Period (WeekPlacebo-Controlled 0-16) Period (Week 0-16) year. Serious infections includedyear. pyelonephritis. In the placebo group, no serious infection occurred in more pyelonephritis. In the placebo group, no serious infection occurred in more Live studies, overall 23% (207/903) of patients developed antibodies again studies, overall 23% (207/903) of patients developed antibodies against In the placebo-controlled periodInofthe Studies placebo-controlled PS-1, PS-2 and period PS-3ofinStudies the PS-1, PS-2 and PS-3 in the than one evidencewith of increased risk of pegol infections oneofsubject. of subject. increasedThere risk ofis no infections Avoid certolizumab pegol least onewho occasion. Of the 207 patients who certolizumab on atwith least one occasion. Of the on 207at patients 400 mg group, adverse events400 occurred mg group, in 63.5% adverse of subjects events inoccurred the in than 63.5% subjectsThere in theis no evidence continued exposure over time (5.1)]. [see Warningswere and Precautions (5.1)].152 (73%) continued exposuregroup. over time Warnings and Precautions [see werehad antibody positive, 152 (73%) antibody positive, a persistent reduction of drughad a persistent reduction of drug CIMZIA group compared to 61.8% CIMZIA of subjects group compared in the placebo to 61.8% group.of The subjects in the placebo The [see plasma concentration, whichofrepresents concentration, which represents 17% (152/903) the study 17% (152/903) of the study In controlled studies incidence rates of infections controlled the clinical incidence ratesinofpsoriasis, infectionstheplasma rates of serious adverse events rates wereof4.7% serious in the adverse CIMZIAevents groupwere and 4.7% inIn the CIMZIAclinical group studies and in psoriasis, Labo datasuggest from these two studies do not suggest an associatio population. The dataconsisted from thesepopulation. two studiesThe do not an association similar in theTheCIMZIA and consisted placebo groups. The infections were the similar in thereactions CIMZIA andwere placebo groups. infections 4.5% in the placebo group. Table 4.5% 2 summarizes in the placebo thegroup. adverseTable reactions 2 summarizes adverse Interf between the development of antibodies and adverse events. between the development of antibodies and adverse events. primarily of upper tract infections and viral infections upper respiratory infections and respiratory viral infections that occurred at a rate of at least that1%occurred and at ata higher a rate rate of atinleast the 1% CIMZIA and atprimarily a higherofrate in the CIMZIA tract treate (including herpes infections). Serious adverse infection of patientsThewith (including herpes infections). Serious adverse events of infection group than in the placebo group. group than in the placebo group. overall percentage of patients with Theevents overallofpercentage antibodies to certolizumab pegolantibodies to certolizumab pegol activa occurred in CIMZIA-treated patientsperiods during the placebo-controlled periods occurred in CIMZIA-treated patients during the placebo-controlled detectable at least one occasion detectable on at least one occasion was 7%on(105 of 1,509) in thewas 7% (105 of 1,509) in thewitho of theabdominal pivotal studies (pneumonia, abdominal abscess, arthritis and hematoma of the pivotal studies (pneumonia, abscess, and hematoma rheumatoid placebo-controlled rheumatoid placebo-controlled trials.arthritis Approximately one third trials. Approximately one thirdPTT-Lu Table 2: Adverse Reactions Table Occurring 2: Adverse in ≥1% Reactions of Occurring in ≥1% of 2 study (urinary infection) Phase 2gastroenteritis, study (urinary tract infection, infection) and Phase tractandinfection, (3%, 39 1,509) ofwith these patients had antibodies with neutralizing (3%, 39 ofgastroenteritis, 1,509) of these patients hadofantibodies neutralizing Throm Subjects in the CIMZIA Group Subjects andinMore the CIMZIA Frequently Group than and and More Frequently than disseminated tuberculosis).and disseminated tuberculosis). in vitro. Patients treated with concomitant immunosuppressants activity in vitro. Patients treated activity with concomitant immunosuppressants and t in the Placebo Group in the in the Plaque Placebo Psoriasis GroupStudies in the Plaque Psoriasis Studies (MTX) had a lower rate of antibody development than patients not takin (MTX) had a lower rate of antibody development than patients not taking Instru Tuberculosis and Opportunistic Infections Tuberculosis and Opportunistic Infections PS-1, PS-2, and PS-3. PS-1, PS-2, and PS-3. immunosuppressants at baseline. Patients treated with concomitant immunosuppressants at baseline. Patients treated with concomitant Interf completed andinongoing global clinical studies in all indications In completed and ongoing globalInclinical studies all indications immunosuppressant therapy in RA-I, RA-II, RA-III had a lowerhas raten therapyis (MTX) in RA-I, RA-II, RA-III had a(MTX) lower rate CIMZIA CIMZIA CIMZIA CIMZIA CIMZIA-treated patients,isthe immunosuppressant overall rate of tuberculosis including 5,118 CIMZIA-treated including patients, 5,118 the overall rate of tuberculosis of neutralizing formation of neutralizing antibody formation overall than antibody patients treated withoverall than patients treated witheffect 200 mg5 200 mg5 400 mg 400 mg approximately 0.61 per 100 patient-years across all indications. approximately 0.61 per 100 patient-years across all indications. Placebo Placebo CIMZIA monotherapy RA-IV dose (2% of vs.400 8%). Both the loading dose of 40 CIMZIA vs. 8%). Both the inloading every other every every otherAdverse every other Adverse majoritywith of cases occurredrates in countries high monotherapy endemic ratesinofRA-IV TB. (2% Theother majority of ncases occurred inThe countries high endemic of TB. with n (%) (%) at Weeks and 4 and concomitant use ofUSE MTX every otherandweek at Weeks mg 0, 2every and 4other andweek concomitant use0,of2MTX week Reactions week week week Reactions Reports(miliary, include lymphatic, cases of disseminated (miliary,mglymphatic, peritoneal) Reports includeN=157 cases of disseminated and peritoneal) Preg N=157 were associated with reduced immunogenicity. reduced immunogenicity. n (%) n (%) n (%) nas(%) as welltime as pulmonary time towere onsetassociated of TB for with all patients well as pulmonary TB. The median to onset ofTB. TB The for allmedian patients Pregn N=342 N=350 N=342 N=350 Antibody formation wasplasma associated with lowered drug plasma was associated with lowered drug exposedwas to CIMZIA acrossInalltheindications 345 days.formation In the studies exposed to CIMZIA across all indications 345 days. studies was Antibody There concentration reduced In patients receiving the recommende andexposed reduced efficacy. In patientsand receiving theefficacy. recommended withcases CIMZIA RA, there wereexposed 36 cases of TBconcentration among 2,367 with CIMZIA in RA, there were 36 of TBinamong 2,367 in wo Upper Upper CIMZIA dosage of 200 mg every other week with concomitant MTX, CIMZIA dosage of 200 mg every other week with concomitant MTX, patients, fatal cases. Rare cases of opportunistic infections patients, including some fatal cases. Rareincluding cases of some opportunistic infections health respiratory respiratory the ACR20 response was lower among antibody-positive patients than the ACR20 response was lower among antibody-positive patients than 1 alsotrials. beenInreported these clinical also been33reported clinical Phase 2inand Phase 3 trials. In Phase 2 and Phase 3 tract infections1 75 (21.9)tract infections 68 (19.4) 75 (21.9) 33 (21.0) 68 have (19.4) (21.0)in thesehave Moth among (Study RA-I, 48% versus 60%; Study (Studyantibody-negative RA-I, 48% versuspatients 60%; Study studies with plaqueof psoriasis, were 2antibody-negative cases of TB amongpatients studies with CIMZIA in plaque psoriasis, thereCIMZIA were 2incases TB amongthereamong Terat RA-II 35% versus 59%,toorespectively). RA-II 35% versus 59%, respectively). In Study RA-III, few patientsIn Study RA-III, too few patients Headache2 13 (3.8)Headache210 (2.9) 13 (3.8) 4 (2.5) 101112 (2.9)exposed 4patients (2.5) [see Warnings 1112 exposed patients [see Warnings and Precautions]. and Precautions]. Disea antibodies meaningful analysis of ACR20 response developed antibodies to allow fordeveloped meaningful analysistoofallow ACR20forresponse Injection site Injection site Malignancies pregn Malignancies by (monotherapy), antibody status. the In Study (monotherapy), the ACR20 response by antibody status. In Study RA-IV ACR20RA-IV response 3 3 reactions 11 (3.2)reactions 6 (1.7) 11 (3.2) 1 (0.6) 6 In(1.7) clinicalincidence studies ofrate CIMZIA, the overall incidence rateversus of malignancies clinical studies1 (0.6) of CIMZIA, theInoverall of malignancies Risk S was 33%versus versusantibody-negative 56%, antibody-positive was 33% 56%, antibody-positive status,versus antibody-negative status, was control similar patients. for CIMZIA-treated For[see someClinical TNF Pharmacology]. was similar for CIMZIA-treated and For some and TNF control patients. respectively Clinical was Pharmacology]. No association was seen Limite respectively No[see association seen Cough 11 (3.2)Cough 4 (1.1) 11 (3.2) 3 (1.9) 4 blockers, (1.1) more 3cases (1.9)of malignancies blockers, more cases of malignancies been observed among have been observed among have between pregn antibody development the development of adverse events. antibody development between and the development of adverseand events. patientscompared receivingtothose TNFpatients blockers[see compared to control patients [see patients receiving those TNF blockers control Herpes Herpes Approximately 8% (22/265) Approximately 8% (22/265) and 19% (54/281) of subjectsand with19% (54/281) of subjects withor oth Warnings and Precautions]. infections4 5 (1.5)infections4 5 (1.4) 5 (1.5) 2 (1.3) 5 Warnings (1.4) and Precautions]. 2 (1.3) psoriasis who received 400 200 mg every 2 weeks and CIMZIA plasm 200 psoriasis who received CIMZIA 400 mg every 2 weeksCIMZIA and CIMZIA Failure 1: Upper respiratory tract infection 1: Upper clusterrespiratory includes upper tract infection respiratorycluster Heart includes upper respiratory Heart Failure every 2 weeks for 48 antibodies weeks, respectively, developed antibodiesthe th mg every 2 weeks for 48 weeks,mgrespectively, developed In placebo-controlled studies, cases of new or worsening of In placebo-controlled and open-label studies, cases of and newopen-label or worsening tract infection, pharyngitis bacterial, tract infection, pharyngitispharyngitis streptococcal, bacterial, pharyngitis streptococcal, to certolizumab pegol.antibodies Of the subjects to certolizumab pegol. Of the subjects who developed to who developed antibodies to cer failure have been reported CIMZIA-treated patients.pegol, The majority in otha heart been reportedheart for CIMZIA-treated patients. The for majority upper respiratory tract infectionupper bacterial, respiratory viral upper tractrespiratory infection bacterial, viralfailure upperhave respiratory certolizumab pegol,that 45%were (27/60) hadasantibodies that were classified certolizumab 45% (27/60) had antibodies classified of theseandcases wereduring mild tothe moderate duringAntibody the first year of neutralizing. fetus of theseand cases were mild to moderate occurred first yearand of occurred tract infection, viral pharyngitis,tract viralinfection, sinusitis, viral and nasopharyngitis. pharyngitis, viral sinusitis, nasopharyngitis. Antibody formation wasplasma associated with lowered drug plasm neutralizing. formation was associated with lowered drug exposure [see Warnings and Precautions]. concentration and reduced efficacy. theor exposure [see Warnings and Precautions]. concentration and reduced efficacy. 2: Headache includes headache 2: and Headache tension includes headache. headache and tension headache. infan Hypersensitivity Reactions Hypersensitivity Reactions A more sensitive and drug tolerant electrochemiluminescence (ECL)-based A more sensitive and drug tolerant electrochemiluminescence (ECL)-based 3: Injection site reactions cluster 3: includes Injectioninjection site reactions site reaction, cluster includes injection site reaction, of va The following symptoms that could be compatible with hypersensitivity The following symptoms that could be compatible with hypersensitivity bridging assay was used for the first time in the nr-axSpA-1 study, bridging assay was used for the first time in the nr-axSpA-1 study, injection site erythema, injectioninjection site bruising, site erythema, injection injection site site bruising, injection site effect reactions have been reported rarely following CIMZIA administration reactions have been reported rarely following CIMZIA administration in ahaving greatermeasurable proportionantibodies of samples having measurable antibodies resulting in a greater proportion resulting of samples discoloration, injection site pain,discoloration, and injectioninjection site swelling. site pain, and injection site swelling. pregn to dermatitis, patients: angioedema, allergic dermatitis,todizziness (postural), to patients: angioedema, allergic dizziness (postural), certolizumab pegol and thusbeing a greater incidence of patients being certolizumab pegol and thus atogreater incidence of patients 4: Herpes infections cluster includes 4: Herpes oral herpes, infections herpes clusterdermatitis, includes oral herpes, herpes dermatitis, pegyl dyspnea, hypotension, reactions, malaise, dyspnea, hot flush, hypotension, injectionhotsiteflush, reactions, malaise,injection site classed as antibody positive. In the placebo-controlled trial in patients classed as antibody positive. In the placebo-controlled trial in patients herpes zoster, and herpes simplex. herpes zoster, and herpes simplex. organ pyrexia, rash, serum sickness, (vasovagal) [see Warnings pyrexia, rash, serum sickness, and (vasovagal) syncope [see and Warnings with non-radiographic after up to 52 weeks of with syncope non-radiographic axial spondyloarthritis, after up toaxial 52 spondyloarthritis, weeks of mg e 5: Subjects received 400 mg 5:of CIMZIA Subjectsat received Weeks 0,400 2, and mg 4, of CIMZIA atand Weeks 0, 2, and 4, and Precautions]. Precautions]. incidencepositive of patients who were antibody positive treatment, the overall incidence treatment, of patients the whooverall were antibody followed by 200 mg every other followed week. by 200 mg every other week. The e certolizumab pegol was 97% antibody (248/255 patients). Of these antibody to certolizumab pegol was 97%to(248/255 patients). Of these Autoantibodies Autoantibodies for th positive patients, titerscertolizumab were associated with reduced certolizumab positivetreated patients, higher titers were associated withhigher reduced In clinical studies in Crohn’s disease, 4% of patients with CIMZIA In clinical studies in Crohn’s disease, 4% of patients treated with CIMZIA Elevated Liver Enzymes Elevated Liver Enzymes backg pegol plasma levels. pegol plasma levels. 2% ofthatpatients treated baseline with placebo that had negative baseline and 2% ofinpatients treated withand placebo had negative Elevated liver enzymes were reported Elevated more liverfrequently enzymesinwere the CIMZIAreported more frequently the CIMZIAU.S. The data above reflect the percentage of patients whose test results were data One aboveofreflect the percentage of patients whose test results were ANAduring titers the developed during theThe studies. the 1,564 studies.positive One of titers the 1,564 treated subjects (4.3% in the 200 treated mg group subjects and(4.3% 2.3%ininthe the200 400mg mggroupANA and titers 2.3%developed in the 400positive mg titers defec considered positivepegol for antibodies to certolizumab pegol in an ELISA, or considered positive for antibodies to certolizumab in an ELISA, or Crohn’s disease patients treated with CIMZIA developed symptoms of a Crohn’s disease patients treated with CIMZIA developed symptoms of a group) than in the placebo-treated group) subjects than(2.5%). in the placebo-treated Of CIMZIA-treated subjects (2.5%). Of CIMZIA-treated and 1 bridging assay, are highly ECL-based bridging assay, and areECL-based highly dependent on theand sensitivity anddependent on the sensitivity and lupus-like syndrome. syndrome. subjects who had elevation of liver subjects enzymes, who had two elevation subjects were of liver enzymes,lupus-like two subjects were Clinic specificity of the assay. specificity of the assay. In clinical trials of TNF blockers, including CIMZIA, in patients with In clinical trials of TNF blockers, including CIMZIA, in patients with discontinued from the trial. In controlled discontinued Phasefrom 3 studies the trial. of In CIMZIA controlled in Phase 3 studies of CIMZIA in Disea RA, some patients have developed ANA. Four patients out of 2,367 RA, some patients have developed ANA. Four patients out of 2,367 Postmarketing ExperiencePostmarketing Experience adults with PsO with a controlledadults periodwith duration PsO with ranging a controlled from 0 toperiod 16 duration ranging from 0 to 16 Publis patients CIMZIA clinical in RA clinical developedadverse clinical reactions signs The clinicaltreated studieswith developed signs studies adverseduring reactions have been identified during post-approva The following havefollowing been identified post-approval weeks, AST and/or ALT elevations weeks, ≥5 xAST ULNand/or occurredALTinelevations 0.9% of CIMZIA ≥5 x ULNpatients occurredtreated in 0.9%with of CIMZIA in RA wom suggestive of a lupus-like syndrome. The impact treatment of a lupus-like syndrome. The impact of long-term treatment use of CIMZIA. Because these reactions use ofof long-term CIMZIA. Because these reactions are reported voluntarily from a are reported voluntarily from a 200 mg or CIMZIA 400 mg arms200 andmgnone or CIMZIA in placebo 400arm. mg arms and none insuggestive placebo arm. mate CIMZIA on thediseases development of autoimmune diseases is unknownsize, it ispopulation with CIMZIA on the developmentwith of autoimmune is unknown uncertainto size, it is not always possible to estimate reliably population of uncertain not alwaysofpossible estimate reliably Psoriasis-Related Adverse EventsPsoriasis-Related Adverse Events adver [see Warnings and Precautions]. [see Warnings and Precautions]. their frequency or establish a causal relationship to drug exposure. their frequency or establish a causal relationship to drug exposure. In controlled clinical studies in psoriasis, In controlled change clinical of plaque studiespsoriasis in psoriasis, into achange of plaque psoriasis into a 37 w Vascular disorder: systemic vasculitis has been identified during postVascular disorder: systemic vasculitis has been identified during postImmunogenicity Immunogenicity different psoriasis sub-type (including different erythrodermic, psoriasis sub-type pustular(including and guttate), erythrodermic, pustular and guttate), for ge approval use of TNF blockers. approval use of TNF blockers. As withis potential all therapeutic proteins, there isThepotential for immunogenicity. The As with all therapeutic proteins, there for immunogenicity. was observed in <1% of CIMZIAwas treated observed subjects. in <1% of CIMZIA treated subjects. Fetal/ of antibodyonformation is highly on the sensitivity detection of antibody formation detection is highly dependent the sensitivity anddependent Skin:including case of severe skin reactions, including Stevens-Johnson Due t Skin: case of severe skinand reactions, Stevens-Johnson specificity of the assay. Additionally, the observed incidence antibody necrolysis, specificity of the assay. Additionally, the observed incidence of antibody syndrome, toxic epidermal necrolysis, multiforme, and new syndrome, toxicof epidermal erythema multiforme, and newerythema or affect

0 to 0.01 the maternal The dosepercentage (200 of the maternal dose (200 dening psoriasis (all sub-types of BLQ or lowclinical levelssignificance is unknownofforBLQ in utero-exposed worsening includingpsoriasis pustular(all andsub-types palmoplantar, including clinical pustularsignificance and palmoplantar, or low levels is unknown for inmg/kg/day). utero-exposedThe percentage 0 to 0.01ofmg/kg/day). mg CIMZIA oncethat every 2 mg weeks), thatdosed reaches infant2ranged infants.during Additional data availableinfants. from one exposeddata infant suggestfrom thatone exposed lichenoid skin reaction) have andbeen lichenoid identified skin during reaction) post-approval have been identified post-approval Additional available infantdosed suggest CIMZIA onceanevery weeks), that reaches an infant ranged 0.56% based onfrom samples withto measurable certolizumab CIMZIA may be eliminated at a slower than inatadults (seerate infrom of TNF blockers. use of TNF blockers. CIMZIArate mayinbeinfants eliminated a slower infants than toin 4.25% adults (see 0.56% 4.25% based on samples with measurable certolizumab pegol concentration. adverseconcentration. reactions were the 17 reactions were noted in the 17 Data). The safety of administering live or vaccines inlive or live-attenuated Data). Thelive-attenuated safety of administering vaccines inNo serious pegol Nonoted seriousin adverse une System Disorders: sarcoidosis Immune System Disorders: sarcoidosis breastfed infants in the study. breastfed infants in the study. exposed infants is unknown. exposed infants is unknown. plasms benign, malignant and Neoplasms unspecified benign, (including malignant cysts and unspecified (including cysts and In a separate study, plasma certolizumab pegolstudy, concentrations were In a separate plasma certolizumab pegol concentrations were Data ps): Melanoma, Merkel cellpolyps): carcinoma Melanoma, (neuroendocrine Merkel carcinoma cell carcinoma of (neuroendocrine carcinoma of Data collected 4 weeks after birth in 9collected breastfed4 weeks infants after whosebirth mothers had infants whose mothers had in 9 breastfed Human Data skin) [see Warnings and Precautions]. the skin) [see Warnings and Precautions]. Human Data been currently taking CIMZIA (regardless of being exclusively ts been currently taking CIMZIA breastfed (regardlessorof being exclusively breastfed or A limited number of pregnanciesAhave been reported in the ongoing limited number of pregnancies have been reported in the ongoing UG INTERACTIONS DRUG INTERACTIONS Certolizumab pegol in infant plasma was not measurable i.e.,plasma below was not measurable i.e., below not). Certolizumab pegol in infant pregnancy exposure registry. Duepregnancy to the small numberregistry. of CIMZIA-exposed exposure Due to the smallnot). number of CIMZIA-exposed with Anakinra, Abatacept, Use with Rituximab, Anakinra,and Abatacept, Rituximab, and 0.032 mcg/mL. pregnancies with known outcomes (n=54), with no meaningful comparisons pregnancies known outcomes (n=54), no meaningful comparisons 0.032 mcg/mL. alizumab Natalizumab between the exposed group andbetween control groups may begroup conducted to groups the exposed and control may be conducted Pediatric Use to Pediatric Use ncreased risk of serious infections An increased has beenriskseen of serious in clinical infections studies has beendetermine seen in clinical studies with CIMZIA an association and an major birth defects adverse determine association with orCIMZIA and major birthanddefects or adversein pediatric Safety effectiveness have not been established. Safetypatients and effectiveness in pediatric patients have not been established. her TNF-blocking agents used of inother combination TNF-blocking withagents anakinra usedor in combination with anakinra or pregnancy outcomes. pregnancy outcomes. Due to its inhibition of TNFα, CIMZIA pregnancy Due toadministered its inhibition during of TNFα, CIMZIA administered during pregnancy acept, with no added benefit. abatacept, Formal drug withinteraction no added benefit. studies have Formal drug interaction studies have couldwomen affecttreated immunewith responsescould in theaffect in utero-exposed newbornin and A multicenter was conducted in 16 women with in 16 A multicenter clinical studytreated was conducted immune responses the in utero-exposed newborn and been performed with rituximab not orbeen natalizumab. performed Because with rituximab of the or nature natalizumab. Becauseclinical of thestudy nature infant2 weeks [see Use in Specific CIMZIA with at a maintenance 200 mg 2 weeksdose or 400 mg mg every at aevery maintenance of 200 or 400 mg Populations)]. infant [see Use in Specific Populations)]. e adverse events seen withofthese the adverse combinations eventswith seenTNF withblocker these combinations TNF blocker dose ofCIMZIA 4 weeks during the third trimester of pregnancy for rheumatological every 4 weeks during the third trimester of pregnancy for Use rheumatological Geriatric Use Geriatric apy, therapy, result similar from thetoxicities use of may CIMZIA alsoin result these fromevery the use of CIMZIA in these ve similar toxicities may also or Crohn’s disease. last doseorofCrohn’s CIMZIAdisease. was given Theonlastaverage dose of CIMZIA given on average Clinical was studies of CIMZIA did notClinical include sufficient numbers studies of CIMZIA did ofnotpatients include sufficient numbers of patients binations. There is not enough combinations. informationThere to assess is nottheenough safetyinformation and diseases to assess the safety and Thediseases 11 the daysuse prior delivery 1 todays 27 prior days).to Certolizumab delivery (rangepegol 1 to 27 days). agedCertolizumab 65 and overpegol to determineaged whether theyover respond differentlywhether from they respond differently from 65 and to determine acy of such combination therapy. efficacyTherefore, of such combination the use of CIMZIA therapy. in Therefore, of to CIMZIA in (range11 plasma concentrations were measured in samples from mothers and plasma concentrations were measured in samples from mothers and younger subjects. Other reportedyounger clinicalsubjects. experience hasreported not identified Other clinical experience has not identified bination with anakinra, abatacept, combination rituximab, with anakinra, or natalizumab abatacept, is notrituximab, or natalizumab is not infants using an assay that can measure certolizumab pegol concentrations infants using an assay that can measure certolizumab pegol concentrations differences in responses between the elderly and younger patients. differences in responses between the elderly and younger patients. recommended Precautions].[see Warnings and Precautions]. emmended [see Warnings and at or above 0.032 mcg/mL. Certolizumab concentrations at or above pegol 0.032plasma mcg/mL. Certolizumab pegol plasmapharmacokinetic concentrations analyses Population of patients enrolled inanalyses CIMZIA of patients enrolled in CIMZIA Population pharmacokinetic enstVaccines Live Vaccines measured in the mothers at delivery (range: 4.96 to 49.4 mcg/mL) measured in the mothers at delivery (range: 4.96 49.4 mcg/mL) clinicaltostudies concluded that there no apparent difference in drug clinicalwas studies concluded that there was no apparent difference in drug d use of live (including attenuated) Avoid usevaccines of live (including concurrentlyattenuated) with CIMZIAvaccines with non-pregnant CIMZIA were wereconcurrently consistent with women’s plasma consistent with concentrations non-pregnant women’s plasma concentrations concentration regardless of age.concentration Because thereregardless is a higher incidence of there is a higher incidence of of age. Because Warnings and Precautions].[see Warnings and Precautions]. in Study RA-I [see Clinical Studies]. Certolizumab in Study RA-I [seepegol Clinicalplasma Studies]. Certolizumab pegol inplasma infections the elderly population in general, caution when treating infections in theuse elderly population in general, use caution when treating concentrations were not measurable in 13 out of 15not infants at birth. inThe13 outtheofelderly concentrations were measurable 15 infants birth. The oratory Tests Laboratory Tests withatCIMZIA [see Warnings andwith Precautions]. the elderly CIMZIA [see Warnings and Precautions]. on concentration of certolizumab in one infant was 0.0422pegol mcg/in one infant was 0.0422 mcg/ concentration of certolizumab ference with certain coagulation Interference assays has withbeen certain detected coagulation in patients assays has been detected in patients pegol OVERDOSAGE OVERDOSAGE at birth (infant/mother ratiobirth of (infant/mother 0.09%). In a second mL at plasmainfant, ratio of 0.09%). In a second infant, ed with CIMZIA. Certolizumab treated pegolwith mayCIMZIA. cause erroneously Certolizumabelevated pegol maymLcause erroneously elevatedplasma Theconcentration maximum tolerated dose ofThecertolizumab pegol hasdose not been maximum tolerated of certolizumab pegol has not been delivered by emergency section,bythe concentration was 0.485 delivered emergency Caesarean section, the was 0.485 ated partial thromboplastin activated time (aPTT) partial assay thromboplastin results in patients time (aPTT) assay results in patients Caesarean established. up to 800established. mg subcutaneous mg/kg Doses ofand up 20 to 800 mg subcutaneous and 20 mg/kg plasmamcg/mL ratio of (infant/mother 4.49%). At Weekplasma 4 andratio Week of 4.49%). At WeekDoses 4 andof Week out coagulation abnormalities. without This effect coagulation has been abnormalities. observed with Thisthe effectmcg/mL has been(infant/mother observed with the intravenous have administered withouthave evidence of dose-limiting intravenous been administered without evidence of dose-limiting 8, all 15 infants hadPartial no measurable 16 exposed 8, allconcentrations. 15 infants hadAmong no measurable concentrations. Among 16been exposed Lupus Anticoagulant (LA) testPTT-Lupus and Standard Anticoagulant Target Activated (LA) testPartial and Standard Target Activated toxicities. In cases who of overdosage, it is recommended that patientsit be In cases of overdosage, is recommended that patients be one serious Stago, adverse reaction wasone reported a neonate who was reported infants, seriousinadverse reaction in a neonate was toxicities. mboplastin time (STA-PTT) Automate Thromboplastin tests from time Diagnostica (STA-PTT) Automate Stago, testsinfants, from Diagnostica for white any adverse reactionsclosely or effects, appropriate monitored for anyandadverse reactions or effects, and appropriate empirically withfrom intravenous antibiotics due with to anintravenous increased white treated empirically antibioticsmonitored due to anclosely increased the HemosIL APTT-SP liquid and the HemosIL HemosIL lyophilized APTT-SPsilica liquidtests andfrom HemosILtreated lyophilized silica tests treatment immediately. symptomatic treatment instituted immediately. bloodmay cellbecount; bloodas cultures certolizumab pegolnegative.symptomatic bloodnegative. cell count;Theblood cultures were The certolizumab pegolinstituted ng umentation Laboratories. Other Instrumentation aPTT assays Laboratories. may be affected OtherasaPTT well.assays affected well. were plasma concentrations for this infant were not measurable at birth, plasma concentrations for this infantWeek were notPATIENT measurableCOUNSELING at birth, Week INFORMATION PATIENT COUNSELING INFORMATION ference with thrombin time Interference (TT) and prothrombin with thrombin timetime (PT)(TT) assays and prothrombin time (PT) assays Week 8.therapy has an 4, or Week 8. See FDA-approved patient labeling See (Medication FDA-approvedGuide) patient labeling (Medication Guide) not been observed. There ishas no evidence not been that observed. CIMZIAThere therapy is nohasevidence an 4, thatorCIMZIA t on in vivo coagulation. effect on in vivo coagulation. In another clinical study conducted in 10 pregnant women with Crohn’s In another clinical study conducted in 10 pregnant withInfections Crohn’s Risk of Serious Infections Risk ofwomen Serious 00 mg every 4 weeks for every mother), disease treated with CIMZIA (400 mg every 4Inform weekspatients for everythatmother), CIMZIA may lowerpatients the ability the immune Inform thatofCIMZIA may lower the ability of the immune EX IN SPECIFIC POPULATIONS USE IN SPECIFIC POPULATIONS disease treated with CIMZIA (400 certolizumab pegol concentrations were measured maternal blood certolizumab pegolinconcentrations were measured blood Instruct systemin tomaternal fight infections. patients of the importance of patients of the importance of system to fight infections. Instruct gnancy Pregnancy as well as in cord and infant blood at the day of birth with an assay as well as in cord and infant blood at the day of birth with an assay contacting their doctor if they develop anytheir symptoms infection, contacting doctor ifofthey develop any symptoms of infection, nancy Exposure Registry Pregnancy Exposure Registry that can measure concentrations at or above 0.41 mcg/mL. The last that can measure concentrations at or above 0.41 mcg/mL. The last including tuberculosis and reactivation hepatitis B virus infections. of hepatitis B virus infections. includingoftuberculosis and reactivation e is a pregnancy exposure registry There isthat a pregnancy monitors pregnancy exposure registry outcomes that monitors pregnancy outcomes doseForofmore CIMZIAinformation, was given on average days prior to delivery (range19 days dose of19CIMZIA was given on average prior tocaution deliveryshould (rangebe exercised ed exposed to CIMZIA during Because in prescribing CIMZIA to patientsin prescribing CIMZIA to patients Because caution should be exercised omen in women pregnancy. exposed Fortomore CIMZIA information, during pregnancy. 5 to 42 days). Plasma certolizumab pegol concentrations ranged from 5 to 42 days). Plasma certolizumab pegol concentrations ranged from with clinically important active infections, advise patientsactive of theinfections, advise patients of the with clinically important thcare providers or patients can healthcare contact:providers or patients can contact: not measurable to 1.66 mcg/mLnotinmeasurable cord blood and 1.58mcg/mL mcg/mLinincord blood to 1.66 and 1.58 mcg/mL in importance of informing their health care providers abouttheir all aspects of providers about all aspects of importance of informing health care herToBaby Pregnancy Studies MotherToBaby conducted byPregnancy the Organization Studies conducted of by theblood; Organization of from 1.87 infant and ranged 59.57and mcg/mL maternal infanttoblood; rangedinfrom 1.87 to 59.57their mcg/mL maternal healthin[see Warnings andtheir Precautions]. health [see Warnings and Precautions]. tology Information Specialists Teratology (OTIS).Information The OTIS AutoImmune Specialists (OTIS). The OTISPlasma AutoImmune blood. certolizumab pegol concentrations were lowerpegol (by atconcentrations were lower (by at blood. Plasma certolizumab ases Diseases or visit Studyhttp://mothertobaby.org/ at 1-877-311-8972 or visitleast http://mothertobaby.org/ Malignancies Malignancies 75%) in the infants than inleast mothers low than placental 75%)suggesting in the infants in mothers suggesting low placental e Study at 1-877-311-8972 nancy-studies/ pregnancy-studies/ patients about the possible riskpatients of lymphoma other risk of lymphoma and other Counsel about and the possible transfer of certolizumab pegol. Intransfer one infant, the plasmapegol. certolizumab of certolizumab In one infant, Counsel the plasma certolizumab malignancies while4 receiving [see Warnings and Precautions]. malignancies while receiving CIMZIA [see Warnings and Precautions]. pegol concentration declined frompegol 1.02concentration to 0.84 mcg/mL 4 weeks declinedover from 1.02 to 0.84 mcg/mL over weeks CIMZIA Risk Summary ,Summary suggesting certolizumab may bethat eliminated at a slower suggesting certolizumab pegolrate mayinbe eliminated at a slower rate in Other Medical Conditions ed data from the ongoing pregnancy Limited data registry from on theuse ongoing of CIMZIA pregnancy in registry on usethat of CIMZIA in pegol Other Medical Conditions adults. pregnant to inform women a riskareof not major sufficient birth defects to inform infants a risk ofthan major birth defects infants than adults. .nant women are not sufficient Advise patients to report any signs of new or worsening medical Advise patients to report any signs of new or worsening medical her adverse pregnancy outcomes. or otherHowever, adverse pregnancy certolizumab outcomes. pegol However, certolizumab conditions such as heart disease, neurological autoimmune conditions suchdisease, as heartordisease, neurological disease, or autoimmune Animal Data pegol Animal Data ma concentrations obtained plasma from twoconcentrations studies of CIMZIA obtained use from duringtwo studies of CIMZIA use during disorders. Adviseorpatients promptly anypatients symptoms suggestive disorders. Advise to report promptly any symptoms suggestive Because certolizumab pegol doesBecause not cross-react with mouse or ratnot TNFa, certolizumab pegol does cross-react with mouse rat TNFa,to report hird trimester of pregnancy the demonstrated third trimester thatofplacental pregnancy transfer demonstratedreproduction that placental transfer of a cytopenia such as bruising,ofbleeding, or persistent fever [see a cytopenia such as bruising, bleeding, or persistent fever [see studies were performed in rats using a rodent anti-murinein rats using reproduction studies were performed a rodent anti-murine rtolizumab pegol was negligible of certolizumab in most infants pegolatwas birth,negligible and lowin most TNFa infantspegylated at birth, and Warnings and Precautions]. Warnings and Precautions]. Fab’low fragment (cTN3 PF) similarFab’ to certolizumab TNFa pegylated fragment (cTN3 PF) similar to certolizumab in other Thereinfants are risks at birth to the(see mother Data).andThere arepegol. risks toAnimal the mother and studies reproduction haveAnimal been performed rats during pegol. reproductionin studies have beenHypersensitivity performed in ratsReactions during asher infants at birth (see Data). Hypersensitivity Reactions fetus associated arthritis orwith Crohn’s activedisease. rheumatoid The arthritis or Crohn’s disease. The doses organogenesis at intravenous up to 100 atmg/kg (aboutdoses 2.4 times organogenesis intravenous up to 100Advise mg/kg (aboutto2.4 maassociated with active rheumatoid patients seektimes immediate medical attention they experience Advise patients to seekif immediate medical attention if they experience retical risks of administrationtheoretical of live or risks live-attenuated of administration vaccinesoftolivetheor live-attenuated vaccines to the the recommended human dose the of 400 mg, based human on the surface recommended dose ofarea) 400 mg, based on the surface area)hypersensitivity any symptoms of severe reactions. Advise latexany symptoms of severe hypersensitivity reactions. Advise latexnts exposed in utero to CIMZIA infants should exposed be weighed in uteroagainst to CIMZIA the benefits should be and weighed against the benefits have revealed no evidence ofandharm the fetusnodue to cTN3ofPF.harm to thesensitive havetorevealed evidence fetus duepatients to cTN3that PF.the needle shield patients inside thethat removable capshield of inside the removable cap of sensitive the needle d accinations (see Clinical Considerations). of vaccinationsNo(see adverse Clinical developmental Considerations). No adverse developmental the CIMZIA prefilled syringe contains a derivative naturalcontains rubber latex the CIMZIA prefilledofsyringe a derivative of natural rubber latex Lactation ts were observed in animaleffects reproduction were observed studies during in animal whichreproduction Lactation studies during which [see Warnings and Precautions]. [see Warnings and Precautions]. s Risk Summary Risk Summary nant rats were administeredpregnant intravenously rats were a rodent administered anti-murine intravenously TNFa a rodent anti-murine TNFa a multicenterpegol clinicalduring study of In17alactating women multicenter clinicaltreated study with of 17 lactating women treated with Pregnancy Pregnancy ylated Fab’ fragment (cTN3 pegylated PF) similarFab’ to certolizumab fragment (cTN3 pegolPF)during similar toIncertolizumab CIMZIA 200 mg 2 weeks or 400 mg every 4 weeks, minimal CIMZIA at 200 mg every 2 weeks or 400 mgAdvise everypatients 4 weeks,that minimal there is a pregnancy registry monitors Advise patients thatthat there is a pregnancy registry that monitors nogenesis at up to 2.4 timesorganogenesis the recommended at up tohuman 2.4 times dose the of 400 recommended athuman doseevery of 400 certolizumab pegol concentrations were observed breast milk. Nowere observed certolizumab pegolinconcentrations in breast milk. Noin womenpregnancy pregnancy outcomes exposed tooutcomes CIMZIA during pregnancy; in women exposed to CIMZIA during pregnancy; every four weeks. mg every four weeks. serious adverse reactions were noted the 17 infants seriousin adverse reactionsin the werestudy. noted in the 17 infantscan in the patients callstudy. 1-877-311-8972 [seecan Usecall in Specific Populations]. patients 1-877-311-8972 [see Use in Specific Populations]. estimated background risk of The major estimated birth defects background and miscarriage risk of major birth defects and miscarriage y There are no data on the effectsThere on milk areproduction. no data onInthea separate effects onstudy, milk production. In a separate study, Preparation and Administration of CIMZIA Using the for unknown. the indicated All pregnancies population(s)have are aunknown.certolizumab All pregnancies haveconcentrations a bhe indicated population(s) are pegol were not detected in the plasmawere of 9 not detected certolizumab pegol concentrations in the plasma of 9 Preparation and Administration of CIMZIA Using the ground risk of birth defect, loss, background or otherrisk adverse of birthoutcomes. defect, loss, In the or other breastfed adverse outcomes. the post-partum (see Data). The developmental Prefilled Syringe infants at 4Inweeks breastfed infants at 4 weeks post-partum (see Data). The developmental Prefilled Syringe general population, the estimated U.S. general background population, risks of themajor estimated birth background risks benefits of majorofbirth patients caregivers on howpatients to injectand the caregivers Prefilled Syringe. on how to inject the Prefilled Syringe. and health breastfeeding shouldbenefits be considered along withshould the beInstruct and health of breastfeeding considered alongandwith the Instruct e cts and miscarriage in clinically defects recognized and miscarriage pregnancies in clinically are 2 torecognized 4% mother’s pregnancies 2 tofor4%CIMZIA and any potential adverse effects on the Complete instructions are provided in the instructions Instructionsare for provided Use packaged in the Instructions for Use packaged clinicalareneed mother’s clinical need for CIMZIA and any potential adverse effects on the Complete 15 to 20%, respectively. and 15 to 20%, respectively. in eachmaternal CIMZIA Prefilled each CIMZIA Prefilled Syringe kit. breastfed infant from CIMZIA or breastfed from the underlying infant frommaternal CIMZIA orcondition. from the underlying condition.Syringeinkit. d cal Considerations Clinical Considerations Data Data ase-Associated Maternal and/or Disease-Associated Embryo/FetalMaternal Risk and/or Embryo/Fetal Risk clinical study designed to evaluate breast milk was A multicenter A multicenter clinical study designed to evaluate breast milk was shed data suggest that the Published risk of adverse data suggest pregnancy thatoutcomes the risk ofin adverseconducted pregnancyin 17 outcomes lactatingin womenconducted who werein at17least 6 weeks post-partum lactating women who were at least 6 weeks post-partum al men with rheumatoid arthritiswomen or Crohn’s withdisease rheumatoid is correlated arthritiswith or Crohn’s disease is correlated with and had received at least 3 consecutive of CIMZIA mg every doses of CIMZIA 200 mg every and haddoses received at least200 3 consecutive ernal disease activity and thatmaternal active disease diseaseincreases activity and thethat risk active of disease increases the risk of 2 weeks or 400 mg every 4 weeks for rheumatological disease or for rheumatological disease or 2 weeks or 400 mg every 4 weeks rse pregnancy outcomes, including adverse fetal pregnancy loss, preterm outcomes, delivery including (before fetal loss, preterm delivery (beforeof certolizumab pegol on milk production Crohn’s disease. The effects Crohn’s disease. The effects of certolizumab pegol on milk production weeks of gestation), low birth 37weight weeks(less of gestation), than 2500lowg)birth and weight small (lesswere thannot2500 g) and small studied. The concentration in breast of certolizumab wereofnotcertolizumab studied. Thepegol concentration pegol in breastby: Product manufactured Product manufactured by: estational age birth. for gestational age birth. UCB, Inc.,1950 Lake Park Drive, Smyrna, UCB, Inc.,1950 GA 30080Lake Park Drive, Smyrna, GA 30080 milk was not measurable in 77 milk (56 %) 137 samples taken wasofnotthemeasurable in 77 (56 %) of the 137 samples taken US License No. 1736 US License No. 1736 l/Neonatal Adverse Reactions Fetal/Neonatal Adverse Reactions over the dosing periods using anover assaythethat can periods measureusing certolizumab dosing an assay that can measure certolizumab For more information, go to www.CIMZIA.com For more information, or call 1-866-424-6942. go to www.CIMZIA.com or call 1-866-424-6942. ® is a registered trademark of ® is Group to its inhibition of TNFα, CIMZIA Due toadministered its inhibitionduring of TNFα, pregnancy CIMZIAcould administered pregnancyat could the UCB a registered of Companies. trademark of the UCB Group of Companies. CIMZIA CIMZIA pegolduring concentrations or abovepegol 0.032concentrations mcg/mL. Theat median the mcg/mL. The median or aboveof0.032 ofUCB, the Inc., Smyrna, GA 30080. ©2019 ©2019 All rights UCB, reserved. Inc., Smyrna, GA 30080. All rights reserved. or t immune responses in the affect in utero-exposed immune responses newborninand theinfant. in utero-exposed The estimated newborn and infant. The doses average daily infant was 0.0035 (range: estimated average mg/kg/day daily infant doses was 0.0035 mg/kg/day (range:

FEATURE

FINANCIAL CONSIDERATIONS UNIQUE TO U.S. PHYSICIANS

Simple Steps for Early Action ANDREW HARMS AND MIRIAM SWEENEY 40 | PHYSICIANS OFFICE RESOURCE

For the average U.S. household, everyday living is getting pricey. Childcare, food, energy, transportation, and housing costs are all rising. Among U.S. physicians and healthcare professionals, personal financial matters may make things tougher given high educational debt-loads, capped income levels during residency years, and unique insurance needs. Furthermore, job-related stressors emanating from clinical and patient-care priorities, administrative duties, continuing education, licensing requirements, and professional responsibilities leave little time for prudent, active personal financial management.

living expense considerations, etc.—moving beyond simply providing tuition financing guidance in order to provide holistic financial support and literacy. A great example of this is witnessed at the University of Arkansas for Medical Sciences, where Jason Mizell, M.D., and UAMS faculty have facilitated a popular ‘Business of Medicine’ course since 2012, taught to residents and fourth-year medical students.4 This course serves to teach early-stage physicians both practice management finance (coding, billing, malpractice, etc.) and, very importantly, personal finance.

Self-reported depression and burnout rates are high. In fact, in recent years more than 4 in 10 U.S. physicians report feeling burned out.1 When asked to rate factors that contribute to depression, results from Medscape’s annual National Physician Lifestyle Report indicate personal finances ranked second to job/workplace as a contributing factor.2

Another excellent example of an offering available to medical students is provided by the University of Wisconsin School of Medicine and Public Health. When medical student Rufus Sweeney struck up conversations with his peers some years ago about their personal finances, he was shocked by how few understood their student debt or even knew about options to pay it off. With a grant from the Wisconsin Medical Society, Rufus joined with Emma Crawford, UW SMPH Director of Financial Wellness and Financial Aid Advising, to develop UW-Madison SMPH’s first ever course focused on physician personal finance. This course continues and remains the most popular elective credit offering at the medical school.

When asked what would reduce their burnout, the number one response from physicians (roughly a third) indicated the best way to combat burnout would be increased financial compensation. We want to be paid more. In fact, more money was a more common response than a more manageable schedule. The circumstances facing a physician’s personal finances present a unique challenge to most in medicine, regardless of specialty. A predominant factor to financial troubles for physicians includes the high cost of education required to become a physician. According to the AMA, one in four medical students graduates with training-related debt that exceeds $200,000, and half of medical school graduates report debt burdens greater than $150,000. Those financial burdens are combined with a demanding schedule during graduate medical education and can affect well-being for physician residents and fellows. “Between financial restraints and 80-hour workweeks, trainees often struggle with having the time and budget for necessities. When residency and fellowship programs provide benefits to assist with these needs, it can significantly improve trainee well-being,” said AMA Trustee Jesse Ehrenfeld, MD, MPH.3 Compounding the difficulties, we recognize that the time and attention required to study medicine, biological sciences, and patient care during training to become a physician leaves little room to acquire a solid education in personal financial management. Prioritizing personal financial literacy for early-career physicians Many physicians have access to financial resources early on in their career, but that doesn’t mean they’re confident about their financial situation. At the medical school level, some hopeful trends have emerged to address the rising educational debt levels burdening many graduates. At a handful of US medical schools, financial aid offices have transitioned to financial wellness offices—aiming to better help students with personal financial understanding, housing and

While such personal finance educational initiatives exemplified by UAMS and UW-Madison go a long way to improving financial literacy for young physicians, the trend to educate and empower physicians in the way of personal finances should be prioritized in order to meet cost of living challenges and resultant burnout rates. An introduction to personal finance is a great offering at the medical school level, and—if followed on with subsequent support at each next stage of a physician’s career—would provide a proper runway to financial health and wellness. At the residency level, new expenditure considerations often outweigh the long-awaited first paycheck. Many times, newly minted residents find themselves unprepared to manage a tight budget. A resident may sometimes find financial resources made available as a new employee helpful—though the quality and availability of personal financial support is disparate and often inadequate. While the financial picture of a resident includes income, the AMA clearly points out the following: “It takes years to realize your earning potential. As a physician, you will not maximize your earnings until the completion of your graduate medical education. The average first-year resident makes around $60,000, (2018 report) and there’s not much wiggle room. Resident salaries are determined by an institution and correlate with training year rather than specialty. So, in a given training institution, all residents who are in their third year of training get the same salary, and all in their sixth year are paid the same.”5 Given the ceiling on income, how many physicians at the resident level have developed the experience and skills to single handedly manage the new challenges to their budget which may stem from debt-repayment, insurance needs, retirement 2022 · ISSUE 3 | 41

FEATURE

saving, and other important considerations? Factoring in time constraints and the reasonable desire for a personal life, very few residents have the time to dedicate to getting a handle on personal finances. A host of negative consequences may arise if physicians make financial mistakes at these early stages. Where to start? Where to turn for help? Start simply. Financial health should be treated in a similar way to attending to physical and mental health. When viewed from this perspective, the training of physicians gives this occupational group an advantage when tackling personal finances. Let’s outline some simple steps early-career physicians can take to prepare for a healthier financial future: BECOME FAMILIAR WITH YOUR FINANCIAL VITAL SIGNS

While carving out time from a busy schedule may seem impossible, scheduling a bit of time to learn some basics about your individual circumstances is essential. Dedicate some time—think about this as you would think about making an appointment with a doctor. Put it on your calendar. Begin with some basic information gathering: Identify all sources of household income (review your paychecks, line by line); identify your fixed monthly expenses (housing payments, childcare costs, set-aside contributions for savings, etc.), as well as your variable monthly expenses (utilities, subscription services, transportation costs, etc.). As in most things in life, the best first step is figuring out where you are. CONSTRUCT A MONTHLY BUDGET

You may think of this step as you would a treatment regimen. Crafting a monthly financial plan that identifies each incoming dollar and prudently purposes each outgoing dollar will provide a way forward and likely reduce the mental burden of financial unknowns. There are many good budgeting templates and guides. Like finding a good primary care physician, find yourself a budget that you like and works well for you. And like any treatment regimen, stick to your budget in order to achieve good health. KNOW YOUR DEBT REPAYMENT OPTIONS

For the majority of physicians, this step is vital to understand and implement. One resource worth checking out is provided by Doctored Money6 , a non-profit serving physicians that has wonderful debt repayment tools and calculators. IDENTIFY SUPPORT AND ESTABLISH COMMUNICATION

Assess your surroundings to locate trustworthy financial resources and fiduciary support, if needed. In many cases, the institution with which you are affiliated may have personal financial resources offered. Take advantage of these opportunities when available, if nothing else than to better educate yourself. Once you’ve built a network of professionals with whom you can confide, communicate to them as you would 42 | PHYSICIANS OFFICE RESOURCE

Self-reported depression and burnout rates are high. In fact, in recent years MORE THAN 4 IN 10 U.S.

with your PCP, remembering that your goal is to limit risks and improve your overall health. CONDUCT ROUTINE FINANCIAL CHECK-UPS

Living within a smartly formulated monthly budget is a winning health strategy, and combined with periodic (quarterly, semi-annual, annual) reviews of your financial vitals will increase your ability to achieve your financial goals. Schedule these reviews on your calendar well in advance, and approach them as you would a visit to any healthcare specialist. Satisfied debts, cost of living adjustments, salary increases, unexpected expenses, changes in the investable landscape, and other life events will prompt adjustments to your monthly budget. Regular check-ups will help you recognize and appropriately transition your personal finances. Utilize your network of resources and professional support on a regularly scheduled basis. We’ve been talking a lot about early-career physician groups, but our suggestions are applicable to most, if not all, readers. Address your financial needs with consistency, and in spite of uncertainties facing the cost of goods and households, we’ll make the U.S. healthcare system a secure, confident foundation for personal and community growth.

RESOURCES 1. Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide 2. Medscape National Physician Burnout & Depression Report 2018 3. https://www.ama-assn.org/residents-stu dents/resident-student-health/resident-physi cians-should-get-help-shoulder-financial 4. Business of Medicine Course Preps Med Students for Real World | UAMS News 5. 6 things medical students should know about physician compensation | American Medical Association (ama-assn.org) 6. Doctored Money

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