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.”
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.
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
“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.”
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.
