FBPT

WHY

?

Gaining Control in CFD

CONGENITAL FIBRINOGEN DEFICIENCY (CFD)

PURITY & SAFETY Fibryga is a purified, virus-inactivated human plasma-derived fibrinogen concentrate3

BLEEDING CONTROL Fibryga achieved 99% success, often with a single infusion4

EASE OF USE

WHY

Room temperature storage, no thawing; Octajet transfer device provides for rapid needleless reconstitution within 5 to 10 minutes, low infusion volume3

?

Fibryga is a highly purified, virus-inactivated, human fibrinogen

CO-PAY ASSISTANCE Up to $10,000 per year on out-of-pocket costs for eligible patients

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

including afibrinogenemia and

To contact your local Octapharma Representative

Tel: 201-604-1130

hypofibrinogenemia. Fibryga is not

For all inquiries relating to drug safety, or to report adverse events, please contact our Local Drug Safety Officer:

concentrate indicated for the treatment of bleeding in adults and children with CFD,

approved for dysfibrinogenemia.

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

A GUIDE FOR PATIENTS & CAREGIVERS

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

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.

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.

References: 1. Amesse C, Lacroix S, Lupien G. et al. Canadian Hemophilia Society. Factor I Deficiency, Fibrinogen: An inherited bleeding disorder. 2004.

2. Congenital Afibrinogenemia. National Organization for Rare Diseases (NORD). https://rarediseases.org/rare-diseases/afibrinogenemia-congenital/ Accessed September 29, 2020. 3. Fibryga full Prescribing Information. Paramus, NJ: Octapharma USA, Inc.; rev 2020. 4. Lissitchkov T, et al. J Thromb Haemost. 2020;18:815–824. ©2021. Octapharma USA Inc. All rights reserved.

Date of preparation: 4/2021. FIBR-0148-COT

Please see accompanying full Prescribing Information.

Understanding CFD

Treating CFD

A RARE INHERITED BLEEDING DISORDER

GAIN CONTROL WHEN YOU NEED IT MOST

Little or No Fibrinogen (or Factor I) Is Present in the Blood1

Fibrinogen Concentrate Is the Preferred Choice for Treating CFD, Offering a Range of Benefits

EQUALLY AFFECTS men, women, and people of all races and ethnicities1

• Body cannot form a stable blood clot • CFD can result in mild to severe bleeding

CFD OCCURS IN

1 out of 1,000,000 people WORLDWIDE2

AFIBRINOGENEMIA

HYPOFIBRINOGENEMIA

DYSFIBRINOGENEMIA

Complete absence of fibrinogen in the blood.

Fibrinogen is present, but at a level below normal.

Fibrinogen is present, but it does not work properly.

1

1

VIRAL SAFETY

BLEEDING CONTROL

CONVENIENCE

Less likely to be contaminated with viruses than older treatments 3,4

Proven effectiveness for the treatment of acute bleeding episodes3,4

Storage flexibility, no thawing, fast preparation, easy to administer without delay3

1

• Bruising (skin) • Umbilical cord (after birth) • Nosebleeds • Mucous membrane

• Gastrointestinal (digestive tract) • Bladder (urinary) bleeding • Menstrual bleeding • Joints (knees, ankles)

Occurs spontaneously or after injury, trauma, or surgery1,2

Impact is greater for women due to menstruation, pregnancy, childbirth1

A Multidisciplinary Health Care Team Ensures Comprehensive Care

(hematologist)

Social Worker Physiotherapist Nurse Coordinator Patient

Please see accompanying full Prescribing Information.

Surgeon Orthopedist Dentist Geneticist Rheumatologist Psychiatrist

RECEIVE UP TO

$10,000 PER CALENDAR YEAR

Eligible patients with commercial insurance can receive up to a maximum amount of $2500 in copay assistance per enrollment.

Enrollment can be renewed at Octapharma’s discretion up to 3 times within a calendar year—for a maximum of $10,000.

You must currently be using fibryga, or have a prescription to begin therapy, for the FDA-approved indication for fibryga.

• Co-pay assistance can be applied to co-payments, deductibles and co-insurance that may be associated with the cost of Octapharma products. The Octapharma Co-Pay Assistance Program does not cover costs associated with administration of therapy, such as office visits, infusion costs, or other professional services insurance are not eligible

Fibryga achieved 98.9% success for on-demand treatment of bleeding*4

99 % success

Clot strength increased in every patient within 1 hour of infusion4

*Measured by independent data monitoring and endpoint adjudication committee.

High Standards to Ensure Safety3

Reimbursement Assistance Octapharma provides free assistance with reimbursement, including individual insurance claims processing reviews, assistance in appeals, insurance investigations into product coverage, and gaining approvals for prior authorizations for fibryga.

For more information call the Octapharma Support Center at 1-800-554-4440

• Plasma is collected by FDA-licensed facilities; all donors undergo extensive screening and testing • During manufacturing, fibryga undergoes a multistage process that includes solvent/detergent treatment and nanofiltration to inactivate/remove viruses

Medical Director

OFFERS SIGNIFICANT COST SAVINGS

• Those with Medicare, Medicaid, Medigap, VA, DOD, Tricare or other federal or state government

Provides Rapid and Effective Bleeding Control in CFD Bleeding Can Occur Anywhere in the Body2

Octapharma Co-pay Assistance Program

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

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.

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.

Please see accompanying full Prescribing Information.