FEIBA effectively controls bleeding in major and minor surgical procedures1-11

  • Controlling bleeding during and after surgery in haemophilia patients with inhibitors remains a challenge for physicians5
  • Published studies demonstrate the efficacy, safety and tolerability of FEIBA in a variety of major and minor surgeries

Any supplementary (non-bypassing) therapies are not described. The papers used different study designs, patient populations, definitions of major/minor procedures, outcome criteria, and outcome assessments. Please consult the specific studies for full details of efficacy and safety findings.

Important Safety Information

FEIBA must not be used in the following situations if therapeutic alternatives to FEIBA are available:

  • Hypersensitivity to the product or any of the components.
  • Disseminated Intravascular Coagulation (DIC).
  • Acute thrombosis or embolism (including myocardial infarction).

Thrombotic and thromboembolic events, including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke have occurred in the course of treatment with FEIBA, particularly after administration of doses above the maximum daily dose and/or prolonged application or in patients with other risk factors for thromboembolic events.
As with any intravenously administered plasma product, allergic type hypersensitivity reactions may occur; patients should be informed of the early signs of hypersensitivity reactions. When medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
Administration of FEIBA to patients with inhibitors may result in an initial anamnestic rise in inhibitor levels. Upon continued administration of FEIBA, inhibitors may decrease over time. Clinical and published data suggest that the efficacy of FEIBA is not reduced.

References

  1. 1. Négrier C, Goudemand J, Sultan Y, Bertrand M, Rothschild C, Lauroua P., et al. Multicenter Retrospective Study on the Utilization of FEIBA in France in Patients with Factor VIII and Factor IX Inhibitors. Thromb Haemost. 1997:77:1113-1119.
  2. 2. Lauroua P, Ferrer AM, Guerin V. Successful major and minor surgery using factor VIII inhibitor bypassing activity in patients with haemophilia A and inhibitors. Haemophilia. 2009:15:1300-1307.
  3. 3. Tjønnfjord GE. Activated prothrombin complex concentrate (FEIBA) treatment during surgery in patients with inhibitors to FVIII/IX: the updated Norwegian experience. Haemophilia. 2004:10(Suppl. 2):41-45.
  4. 4. DiMichele D, Négrier C. A retrospective postlicensure survey of FEIBA efficacy and safety. Haemophilia. 2006;12:352-362.
  5. 5. Négrier C, Pousse M, Fleury R, et al. Surgical interventions with FEIBA (SURF)—Studying the feasibility of surgery in inhibitor patients. Poster presented at the International Society on Thrombosis and Haemostasis Congress, 2009.
  6. 6. Kraut EH, Aledort LM, Arkin S, et al. Surgical interventions in a cohort of patients with haemophilia A and inhibitors: an experiential retrospective chart review. Haemophilia 2007; 13:508-517.
  7. 7. Stine KC, Shrum D, Becton DL. Use of FEIBA for invasive or surgical procedures in patients with severe hemophilia A or B with inhibitors. J Pediatr Hematol Oncol 2007; 29:216-221.
  8. 8. Rodriguez-Merchan EC. Some recent developments regarding arthropathy and inhibitors in haemophilia. Haemophilia 2008; 14(2):242-247.
  9. 9. Zulfikar B, Kavakli K, Antmen B, et al. Hemostatic management of surgical procedures with FEIBA: a Turkish case series. Poster presented at the Hemophilia 2008 World Congress. Istanbul, Turkey, 2008.
  10. 10. Rangarajan S, Yee T, Wilde, J. Experience of four UK comprehensive care centres using FEIBA for surgeries in patients with inhibitors. Haemophilia 2010;1-7.
  11. 11. FEIBA Summary of Product Characteristics 2010.

Rapid onset and sustained activity

FEIBA stops bleeds quickly and offers a long dosing interval. Read more

Proven efficacy

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Dosing FEIBA

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