Octapharma USA Sponsors ASA Symposium on Fibrinogen Supplementation in Surgical Patients11-05-2019
JAMA Publishes Clinical Study Results Comparing Fibrinogen Concentrate and Cryoprecipitate in Cardiac Surgery
HOBOKEN, N.J. (November 5, 2019) – Octapharma USA sponsored a scientific symposium, “Fibrinogen Supplementation in Surgical Patients – New Perspectives in Acquired Fibrinogen Deficiency,” at the recent American Society of Anesthesiologists Annual Meeting.
The symposium addressed the global perspectives on patient blood management with respect to fibrinogen replacement in acquired bleeding and treatment options for acquired fibrinogen deficiency (AFD). Researchers discussed the most recent results coming from new clinical studies that are being performed in acquired fibrinogen deficiency patients comparing the efficacy and safety of a human fibrinogen concentrate, fibryga®, and cryoprecipitate in the management of perioperative bleeding. Fibryga® is currently indicated for congenital fibrinogen deficiency. The clinical trials discussed at ASA include:
· FORMA-05: Fibrinogen Concentrate vs. Cryoprecipitate in cytoreductive surgery for Pseudomyxoma Peritonei (PMP); and
· FIBRES: The FIBrinogen REplenishment in Surgery (FIBRES) Randomized Clinical Trial: Fibrinogen Concentrate vs. Cryoprecipitate in Cardiac Surgery.
“The studies presented at the symposium are important contributions to build on the current published research and growing clinical experiences with fibrinogen concentrates for managing bleeding in surgical patients,” said Jerrold Levy, M.D., Symposium Chairman and Professor of Anesthesiology and Surgery, and Co-Director of the Cardiothoracic Surgical Intensive Care Unit at Duke University Medical Center in Durham, N.C.
“These two important clinical trials investigating the use of fibryga® in acquired fibrinogen deficiency have identified fibrinogen concentrate as a potential alternative to cryoprecipitate during severe surgical bleeding,” said Octapharma USA President Flemming Nielsen. “The studies provide important data on fibryga® as a potential alternative to cryoprecipitate in helping doctors to restore normal fibrinogen levels. The FIBRES study has just been published online by the Journal of the American Medical Association (JAMA) and the PMP study has been accepted by the Journal of Thrombosis and Haemostasis with publication expected by the end of the year.” 1, 2
Individual optimization of coagulation in the bleeding surgical patient plays a central role for successful patient blood management. Development of hypofibrinogenemia is an important contributor to coagulopathic bleeding complications. In cases of excessive bleeding and acquired hypofibrinogenemia, the Practice Guidelines for Perioperative Blood Management: An Updated Report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management suggest treatment with either cryoprecipitate or fibrinogen concentrate.3
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 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 approximately 8,314 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 Hoboken, 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.
1 – Phase 2 Study of Fibrinogen Concentrate vs. Cryoprecipitate in Pseudomyxoma Peritonei Surgery: Interim Results, American Society of Anesthesiologists Annual Meeting, poster presentation, October 15, 2018.
2 - Callum J, Farkouh ME, Scales DC, et al. Effect of Fibrinogen Concentrate vs. Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery: The FIBRES Randomized Clinical Trial. JAMA. Published online October 21, 2019. doi:10.1001/jama.2019.17312.
3 - Practice Guidelines for Perioperative Blood Management: An Updated Report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management. Anesthesiology 2015;122(2):241-275.
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