The use of FEIBA in on-demand therapy

FEIBA on-demand therapy is proven effective

International consensus guidelines by Teitel el al. for problem bleeds7

Learn from international consensus guidelines developed to aid in the management of difficult-to-treat bleeds in patients with inhibitors. "The focus of these guidelines is to optimise the timing of treatment decisions by evaluating and making treatment changes at earlier time points than may currently be practiced by many physicians."7

Cost-effectiveness of FEIBA in on-demand bleeds

  • Comparing the cost of therapy must involve a comprehensive clinical perspective that considers the efficacy of two products
  • A head-to-head study is most appropriate for conducting health economic analyses
  • The FENOC study was the first to evaluate the use of bypassing agents in inhibitor patients in a comparative way.1 Prior to FENOC, health economic analyses comparing FEIBA and rFVIIa were based on models developed from historical studies independently examining FEIBA and rFVIIa. Learn more about the FENOC study.
  • Based on a cost-effectiveness analysis, the average cost per treatment episode was significantly lower for FEIBA in most patients (45 out of 48).8*

*Using efficacy data from the FENOC study and 2005 product pricing in the U.S., Sweden and Turkey.

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. Astermark J, Donfield SM, DiMichele DM, Gringeri A, Gilbert SA, et al. A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study. Blood. 2007;109(2):546-551.
  2. 2. DiMichele D, Négrier C. A retrospective postlicensure survey of FEIBA efficacy and safety. Haemophilia. 2006;12:352-362.
  3. 3. Négrier C. FEIBA VH In Home Treatment— A 3-Year Prospective Experience. Haemophilia. 1998:4(3): 238, Abstract 330.
  4. 4. 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.
  5. 5. Hilgartner MW, Aledort L, Andes A, Gill, J, et al. Efficacy and safety of vapor-heated anti-inhibitor coagulant complex in hemophilia patients. Transfusion. 1990:30(7):626-630.
  6. 6. Hilgartner MW, Knatterud GL. The use of factor eight inhibitor by-passing activity (FEIBA immuno) product for treatment of bleeding episodes in haemophiliacs with inhibitors. Blood. 1983:61:36-40.
  7. 7. Teitel J, Berntorp E, Collins P, D'Oiron R, Ewenstein B, Gomperts E, et al. A systematic approach to controlling problem bleeds in patients with severe congenital haemophilia A and high-titre inhibitors. Haemophilia. 2007:13:256-263.
  8. 8. Steen Carlsson K, Astermark J, Donfield S, Berntorp E. Cost and outcome: comparisons of two alternative bypassing agents for persons with haemophilia A complicated by an inhibitor. Thromb Haemost 2008;99(6):1060-1067.

Integral to inhibitor management

Learn how FEIBA is integral to the management of patients with inhibitors. Read more

Rapid onset and sustained activity

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

Proven in on-demand therapy

Learn about the efficacy of FEIBA in on-demand treatment. Read more

Publications

Access articles related to managing haemophilia patients with inhibitors. Read more