FEIBA is effective in acquired haemophilia, a rare disorder1-3

Acquired haemophilia is a rare disorder4

  • Acquired haemophilia is caused by autoantibody formation to FVIII4
  • The incidence is 0.2 to 1.48 cases per million per year4-5
  • Males and females are equally affected6
  • It usually occurs in older adults ≥65 years4
  • Bleeding episodes may be severe, difficult to control and sometimes fatal4
  • FVIII level and inhibitor titre at presentation are not useful for predicting severity of bleeding events4

Efficacy of FEIBA in acquired haemophilia

  • Efficacy of FEIBA was rated excellent or good in 89% in a French retrospective study (n=55 bleeding episodes).1 FEIBA dosage of 68 U/kg (range: 35-80) was well tolerated in 95% of cases with no major adverse events1
  • In a U.S. retrospective study, 86% of patients overall achieved a complete response for moderate or severe bleeding (n=55 bleeding episodes)2*
  • 100% of patients had excellent hemostasis (no bleeding complications or bleeding was controlled) with FEIBA in a Norwegian prospective study (n=7 bleeding episodes)3

*29 out of 34 patients may have received additional immunosuppressants

Tolerability of FEIBA in acquired haemophilia

  • FEIBA is well tolerated1-3
  • Tolerability rated excellent or good in 95% of cases1

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. Goudemand J. Treatment of bleeding episodes occurring in patients with acquired haemophilia with FEIBA: the French experience. Haemophilia: 2004:10(Suppl 3),68-72: abstract 14 PO 14.
  2. 2. Sallah S. Treatment of acquired haemophilia with factor eight inhibitor bypassing activity. Haemophilia. 2004:10:169-173.
  3. 3. Holme PA, Brosstad F, Tjønnfjord GE. Acquired haemophilia: management of bleeds and immune therapy to eradicate autoantibodies. Haemophilia. 2005:11:510-515.
  4. 4. Collins PW, Hirsch S, Baglin TP, Dolan G, Hanley J, Makris M, et al. Acquired haemophilia A in the United Kingdom: a 2-year national surveillance study by the United Kingdom Haemophilia Centre Doctors' Organisation. Blood: 2007:109(5):1870-1877
  5. 5. Zakarija A, Green D. Acquired Hemophilia: Diagnosis and Management. 27-33.
  6. 6. Hay C. Acquired haemophilia. Bailliere's Clinical Haematology. 1998:11(2):287-303.

Rapid onset and sustained activity

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

Proven efficacy

Discover the efficacy of FEIBA in both on-demand and prophylaxis treatment. Read more

Dosing FEIBA

Learn how to dose FEIBA. Read more