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Intended for US HCPs Only

References

  1. FEIBA Prescribing Information.
  2. Turecek PL, Varadi K, Gritsch H, Schwarz HP. FEIBA: mode of action. Haemophilia. 2004;10(suppl 2):3-9.
  3. Antunes SV, Tangada S, Stasyshyn O, et al. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors. Haemophilia. 2014;20:65-72.
  4. Data on file.
  5. Négrier C, Lienhart A, Numerof R, et al. SURgical interventions with FEIBA (SURF): international registry of surgery in haemophilia patients with inhibitory antibodies. Haemophilia. 2013;19:e143-e150.
  6. Gomperts ED. FEIBA safety and tolerability profile. Haemophilia. 2006;12(suppl 5):14-19.
  7. Curling J, Goss, N, Bertolini J. The history and development of the plasma protein fractionation industry. In: Bertolini J, Goss, N, Curling J. Production of plasma proteins for therapeutic use. Hoboken, New Jersey: John Wiley & Sons, Inc; 2013.
  8. Kingdon HS, Lundblad RL. An adventure in biotechnology: the development of haemophilia A therapeutics—from whole-blood transfusion to recombinant DNA to gene therapy. Biotechnol Appl Biochem. 2002;35;141-148.
  9. U.S. Food & Drug Administration. Summary basis for regulatory action. http://www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm381137.pdf. Published December 4, 2013. Accessed October 10, 2016.
  10. Grillberger L, Kreil TR, Nasr S, Reiter M. Emerging trends in plasma-free manufacturing of recombinant protein therapeutics expressed in mammalian cells. Biotechnol J. 2009;4:186-201.
  11. U.S. Food & Drug Administration. Clinical review efficacy supplement. http://www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm381140.pdf. Accessed October 10, 2016.
  12. February 2, 2011 approval letter-FEIBA. U.S. Food & Drug Administration website. http://www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm242653.htm. Accessed October 10, 2016.
  13. December 16, 2013 approval letter-FEIBA. U.S. Food & Drug Administration website. http://www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm379418.htm. Accessed October 10, 2016.
  14. Varadi K, Négrier C, Berntorp E, et al. Monitoring the bioavailability of FEIBA with a thrombin generation assay. J Thromb Haemost. 2003;1:2374-2380.
  15. Treatment Guidelines Working Group, on behalf of the World Federation of Hemophilia (WFH). Guidelines for the Management of Hemophilia. 2nd ed. Montreal, Quebec: World Federation of Hemophilia; 2012.
  16. National Hemophilia Foundation. MASAC recommendation regarding the use of bypassing agents in patients with hemophilia A or B and inhibitors. MASAC Document #167. https://www.hemophilia.org/sites/default/files/document/files/167.pdf. Published June 3, 2006. Accessed August 23, 2016.
  17. Obizur Prescribing Information.

Please expand for Indications and Detailed Important Risk Information

Selected Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex]

WARNING: THROMBOEMBOLIC EVENTS

Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors. Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.

FEIBA [Anti-Inhibitor Coagulant Complex] Indications and Detailed Important Risk Information for Healthcare Professionals

Indications for FEIBA [Anti-Inhibitor Coagulant Complex]

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

Detailed Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex]

WARNING: THROMBOEMBOLIC EVENTS

The use of FEIBA is contraindicated in patients with:

Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur with FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors.

Infusion of FEIBA should not exceed a dose of 100 units per kg body weight every 6 hours and daily doses of 200 units per kg body weight. Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. Monitor patients receiving more than 100 units per kg of body weight of FEIBA for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue the infusion and initiate appropriate diagnostic and therapeutic measures.

Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. These reactions can be severe and systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA and provide appropriate supportive care.

Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.

The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.

Please see FEIBA full Prescribing Information