PARAMUS, N.J.--(BUSINESS WIRE)--The National Hemophilia Foundation (NHF) has revised its treatment recommendations for congenital fibrinogen (Factor 1) deficiency to include fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use. Fibryga® is a highly purified, virus inactivated, human plasma-derived fibrinogen concentrate produced by Octapharma.1,2
The NHF Medical and Scientific Advisory Council (MASAC) recommended the revision to the treatment guidelines for Factor 1 deficiency, a rare, inherited blood disorder where the blood does not clot normally. Factor 1 deficiency includes afibrinogenemia, hypofibrinogenemia, and dysfibrinogenemia. Fibryga® is not indicated for dysfibrinogenemia.
“The NHF recommendations are great news for patients and providers who must manage the life-altering challenges of bleeding in congenital fibrinogen deficiency,” said Octapharma USA President Flemming Nielsen. “We are committed to providing life-saving treatment options to people with rare bleeding disorders, including Factor 1 deficiency.”
Fibrinogen replacement therapies for Factor 1 deficiency include fibrinogen concentrates or cryoprecipitate. The NHF MASAC guidelines recommend fibrinogen concentrates for afibrinogenemia and hypofibrinogenemia, and also state that since “cryoprecipitate has not undergone any viral attenuation steps, cryoprecipitate should not be used to treat patients with afibrinogenemia except in life- and limb-threatening emergencies when fibrinogen concentrate is not immediately available.”3
During manufacture, Fibryga® (previously called Fibryna) undergoes solvent/detergent treatment for virus inactivation and nanofiltration for virus removal.1,2 The efficacy of fibryga® was demonstrated in a recent phase 3 clinical study with 25 afibrinogenemia patients who received 131 infusions for treatment of 89 bleeding episodes or prophylaxis for 12 surgeries. Fibryga® demonstrated adjudicated hemostatic efficacy (treatment success) for 98.9% of bleeding episodes and 100% of surgical procedures.4,5
“The MASAC recommendations previously noted that fibrinogen concentrates can be used to treat patients with congenital hypofibrinogenemia and afibrinogenemia, but not dysfibrinogenemia,” said MASAC Member Michael D. Tarantino, M.D., Founder, Medical Director and President of the Bleeding & Clotting Disorders Institute in Peoria, Ill. “Dysfibrinogenemia patients are excluded from clinical trials, but the absence of regulatory approval does not preclude consideration for use by individual practitioners based on their medical judgment. The treatment recommendations have been changed to indicate that fibrinogen concentrates have not received regulatory approval for use in patients with dysfibrinogenemia.”
Fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use, is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Fibryga® is not indicated for dysfibrinogenemia. Fibryga® is stored as a lyophilized powder at room temperature or refrigerated temperature [+2°C to + 25°C (36°F to 77°F)] for up to 30 months from the date of manufacture. The product can be reconstituted with sterile water within approximately 5 to 10 minutes with the provided Octajet transfer device and particle filter (17-micron).
Fibryga® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to fibryga® or its components.
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 human fibrinogen concentrate. 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.
The fibryga® manufacturing process includes a solvent/detergent (S/D) step for virus inactivation, and a nanofiltration step (Planova 20N nanofilter or Pegasus SV4 nanofilter) for virus removal. For complete prescribing information, please visit fibrygausa.com.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Paramus, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharmausa.com.
- Schulz PM, Gehringer W, Nöhring S et al. Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (Fibryga). Biologicals . 2018; 52:72-77.
- Fibryga full Prescribing Information. Hoboken, NJ: Octapharma USA, Inc., rev 2017.
- NHF MASAC Recommendation 263 – MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Other Bleeding Disorders. National Hemophilia Foundation; [Accessed on 9/17/2020]. Available at: https://www.hemophilia.org/sites/default/files/document/files/263_treatment.pdf.
- Lissitchkov T, Madan B, Djambas Khayat C, et al. Efficacy and safety of a new human fibrinogen concentrate in patients with congenital fibrinogen deficiency: an interim analysis of a Phase III trial. Transfusion. 2018;58(2):413-42.
- Lissitchkov T, Madan B, Djambas Khayat C, et al. Fibrinogen concentrate for treatment of bleeding and surgical prophylaxis in congenital fibrinogen deficiency patients. J Thromb Haemost. 2020;18(4):815-824.
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