Menu

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.
See LessMore

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: THROMBOEMBOLIC 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.
;

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

Indications for FEIBA

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

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.

CONTRAINDICATIONS

FEIBA is contraindicated in patients with:

WARNINGS AND PRECAUTIONS

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

Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor or predisposing coagulopathy. Potential benefit of treatment should be weighed against the potential risk of these thromboembolic events.

Infusion should not exceed a single dose of 100 units/kg and daily doses of 200 units/kg. Maximum injection or infusion rate must not exceed 2 units/kg/minute. Monitor patients receiving >100 units/kg 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 FEIBA and initiate appropriate diagnostic and therapeutic measures.

Safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. Cases of thrombotic microangiopathy (TMA) were reported in a clinical trial where subjects received FEIBA as part of a treatment regimen for breakthrough bleeding following emicizumab treatment. Consider the benefits and risks with FEIBA if considered required for patients receiving emicizumab prophylaxis. If treatment with FEIBA is required for patients receiving emicizumab, the hemophilia treating physician should closely monitor for signs and symptoms of TMA. In FEIBA clinical studies TMA has not been reported.

Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur. Symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. 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 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.

FEIBA contains blood group isohemagglutinins (anti-A and anti-B). Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, D, may interfere with some serological tests for red cell antibodies, such as antiglobulin test (Coombs test).

ADVERSE REACTIONS

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.

Serious adverse reactions seen are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

DRUG INTERACTIONS

Consider possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used with FEIBA. No adequate and well-controlled studies of combined or sequential use of FEIBA and recombinant factor VIIa, antifibrinolytics, or emicizumab, have been conducted. Use of antifibrinolytics within approximately 6 to 12 hours after FEIBA is not recommended.

Clinical experience from an emicizumab clinical trial suggests that a potential drug interaction may exist with emicizumab.

Please see FEIBA full Prescribing Information, including BOXED WARNING on Embolic and Thrombotic Events