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References

  1. FEIBA [prescribing information]. Lexington, MA: Takeda Pharmaceutical Company Limited; 2019.
  2. Turecek PL, Váradi 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(1):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(3):e143-e150.
  6. Young G, Auerswald G, Jimenez-Yuste V, et al. When should prophylaxis therapy in inhibitor patients be considered? Haemophilia. 2011;17(5):e849-e857.
  7. López-Fernández MF, Altisent Roca C, Álvarez-Román MT, et al. Spanish consensus guidelines on prophylaxis with bypassing agents in patients with haemophilia and inhibitors. Thromb Haemost. 2016;115(5):872-895.
  8. Aledort LM. Factor VIII inhibitor bypassing activity (FEIBA) - addressing safety issues. Haemophilia. 2008;14(1):39-43.
  9. Gomperts ED. FEIBA safety and tolerability profile. Haemophilia. 2006;12(suppl 5):14-19.
  10. 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.
  11. 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(2):141-148.
  12. 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(2):186-201.
  13. US Food and Drug Administration. User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act. https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/UCM606472.pdf. Updated October 2018. Accessed February 12, 2019.
  14. Golding B. February 2, 2011 approval letter - FEIBA. U.S. Food and Drug Administration website. http://wayback.archive-it.org/7993/20170112211145/http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm242653.htm. Updated February 8, 2011. Accessed February 12, 2019.
  15. Baxter Receives FDA Approval of FEIBA [Anti-Inhibitor Coagulant Complex] for Prophylactic Treatment of Hemophilia A&B Patients with Inhibitors [news release]. Deerfield, IL: Baxter International, Inc; December 19, 2013. https://investor.baxter.com/investors/events-and-news/news/press-release-details/2013/Baxter-Receives-FDA-Approval-of-FEIBA-Anti-Inhibitor-Coagulant-Complex-for-Prophylactic-Treatment-of-Hemophilia-AB-Patients-with-Inhibitors/default.aspx. Accessed December 10, 2018.
  16. Efficacy and safety study of prophylactic versus on-demand treatment with Feiba NF in subjects with hemophilia A or B and a high titer inhibitor. U.S. National Library of Medicine clinical trials website. https://clinicaltrials.gov/ct2/show/NCT00851721?term=NCT00851721&rank=1#moreinfo. Accessed February 4, 2019.
  17. Váradi K, Negrier C, Berntorp E, et al. Monitoring the bioavailability of FEIBA with a thrombin generation assay. J Thromb Haemost. 2003;1(11):2374-2380.
  18. 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; 2012:6-73.
  19. 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/Researchers-Healthcare-Providers/Medical-and-Scientific-Advisory-Council-MASAC/MASAC-Recommendations/MASAC-Recommendation-Regarding-the-Use-of-Bypassing-Agents-in-Patients-with-Hemophilia-A-or-B-and-Inhibitors. Published June 3, 2006. Accessed February 12, 2019.
  20. Smejkal P, Brabec P, Matyskova M, et al. FEIBA® in treatment of acute bleeding episodes in patients with haemophilia A and factor VIII inhibitors: a retrospective survey in regional haemophilia centre. Haemophilia. 2009;15(3):743-751.
  21. Rota M, Cortesi PA, Crea R, Gringeri A, Mantovani LG. Thromboembolic event rate in patients exposed to anti-inhibitor coagulant complex: a meta-analysis of 40-year published data. Blood Adv. 2017;1(26):2637-2642.
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Indications for FEIBA

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

  • Control and prevention of bleeding episodes

Detailed Important Risk Information

WARNING: EMBOLIC and THROMBOTIC EVENTS

  • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA,

Indications for FEIBA

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

  • Control and prevention of bleeding episodes
  • Perioperative management
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

FEIBA is not indicated for the treatment of bleeding episodes resulting from...

Detailed Important Risk Information

WARNING: EMBOLIC and THROMBOTIC EVENTS

  • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors.
  • Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.
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