Fibr 1

MANAGEMENT OF BLEEDING IN Congenital Fibrinogen Deficiency (CFD)

Practical Considerations for Health Care Providers Fibryga is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Fibryga is not indicated for dysfibrinogenemia.

Important Safety Information Contraindications Fibryga® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to Fibryga or its components.

Adverse Reactions The most serious adverse reactions that may be observed with Fibryga are thromboembolic episodes and anaphylactic type reactions. The most common adverse reactions observed in more than one subject in clinical studies with Fibryga (> 5% of subjects) were nausea, vomiting, pyrexia (fever) and thrombocytosis.

Please see accompanying full Prescribing Information.

A BROAD RANGE of Benefits for Providers1-3

Room Temperature Storage and Stability

• No thawing required • No cross-matching blood type • Available off the shelf and at the patient’s bedside • Package includes single-dose bottle of powder (approx. 1 gram);

Octajet transfer device; and a 17-micron particle filter. Components are latex-free

Highly Purified and Pathogen Inactivated/Removed

• Including HAV, HBV, HCV, HIV, and human parvovirus • Solvent/detergent (S/D) step for virus inactivation and nanofiltration step for virus removal

Rapid and Needleless Reconstitution

• Octajet device allows reconstitution within 5 to 10 minutes • Accurate and reliable dosing • Low infusion volume, with no risk of fluid overload Robust Clinical Evidence

• Increases in clot strength comparable to comparator HFC • 99% success for on-demand treatment of bleeding • With a single infusion, treatment success was achieved in 93% of bleeding episodes

• Uncommon allergic and anaphylactic-type reactions “Fibryga has made a real difference at our center.

The needleless reconstitution, the room temperature storage, rapid administration and rapid effect. It’s really changed how we manage our CFD patients.”

Physician Assistant, Hemophilia Treatment Center, Southwest USA

Indications and Usage Fibryga® is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Fibryga is not indicated for dysfibrinogenemia.

2

Please see accompanying full Prescribing Information.

THE ONLY HFC That Offers Eligible Patients

Co-Pay Assistance Up to $10,000 Per Calendar Year The Octapharma Co-Pay Assistance Program provides eligible patients with commercial insurance currently using fibryga, or have a prescription to begin therapy, up to $2500 on out-of-pocket costs associated with fibryga—and up to $10,000 in a calendar year with 3 renewals. This can be applied to co-payments, deductibles, and co-insurance subject to your plan requirements.

Octapharma also provides free assistance with reimbursement, including:

• Individual insurance claims processing reviews • Assistance in appeals • Insurance benefits investigations into product coverage • Gaining approvals for prior authorizations for fibryga HAV = hepatitis A virus; HBV = hepatitis B virus; HCV = hepatitis C virus; HFC = human fibrinogen concentrate; HIV = human immunodeficiency virus.

“We have several CFD patients who needed co-pay assistance, and the Octapharma Co-Pay Program helped make their treatment possible.

The Octapharma team ensured our patients had timely access to fibryga.

They were great to work with and their passion for helping patients was evident. We will be using fibryga first-line for all of our CFD patients.”

HTC Office Staff & Social Worker, Midwest USA

Call the Octapharma Support Center at 1-800-554-4440 for more information on co-pay assistance and reimbursement Important Safety Information Contraindications Fibryga® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to Fibryga or its components.

Adverse Reactions The most serious adverse reactions that may be observed with Fibryga are thromboembolic episodes and anaphylactic type reactions. The most common adverse reactions observed in more than one subject in clinical studies with Fibryga (> 5% of subjects) were nausea, vomiting, pyrexia (fever) and thrombocytosis.

Please see accompanying full Prescribing Information.

3

GAIN CONTROL

in the Treatment of CFD

WHY FIBRYGA? Fibryga is a purified, virus-inactivated human plasma-derived fibrinogen concentrate

BLEEDING CONTROL

EASE OF USE Room temperature storage, no thawing, rapid reconstitution, low infusion volume, with a 17-micron filter and transfer device included in packaging

Fibryga achieved 99% success, often with a single infusion, while increasing clot strength1,2

CO-PAY ASSISTANCE Eligible patients save up to $2500 on OOP costs associated with fibryga—and up to $10,000 per calendar year

OOP = out of pocket.

Contact Octapharma Octapharma USA, Inc. Corporate Office

117 W. Century Road, Paramus, NJ 07652 Tel: 201-604-1130 | www.octapharma.com

Customer Service

General questions about fibrinogen, reconstitution, and product support.

Tel: 866-766-4860 | uscustomerservice@octapharma.com

Octapharma Medical Affairs

usmedicalaffairs@octapharma.com

To contact your local Octapharma Representative

Tel: 201-604-1130

For all inquiries relating to drug safety, or to report adverse events, please contact our Local Drug Safety Officer: Tel: 201-604-1137 | Cell: 201-772-4546 | Fax: 201-604-1141 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

fibrygausa.com Important Safety Information Warnings and Precautions Monitor patients for early signs of hypersensitivity or allergic reactions. If necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving Fibryga®. Treatment with human fibrinogen concentrate has been associated with thrombosis at target plasma fibrinogen levels that were below 150 mg/dL. The thrombotic risks may be greater when the target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of administration versus the risks of thrombosis.

Fibryga is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Please see accompanying full Prescribing Information.

References: 1. Fibryga full Prescribing Information. Paramus, NJ: Octapharma USA, Inc.; rev 2020.

2. Lissitchkov T, et al. J Thromb Haemost. 2020;18:815–824. 3. Ross C, et al. J Thromb Haemost. 2018;16:253-261.

©2021. Octapharma USA Inc. All rights reserved.

Date of preparation: 4/2021. FIBR-0149-PPO