FEIBA may be used to help manage bleeds during ITI1

A review of Immune Tolerance Induction (ITI)

  • Immune tolerance induction (ITI) is the established method for down regulating or eradicating factor VIII inhibitors2 and ideally restoring normal replacement factor VIII kinetics, thus allowing factor VIII to once again be used to treat acute bleeding episodes3
  • Clinically established ITI regimens are based on the original high-dose Bonn protocol that involves frequent, continuing exposure to factor VIII in order to achieve tolerance by antigen overload.3-5 Despite the efficacy of ITI, as many as 40% of inhibitor patients ultimately fail ITI.5 In these situations, bypass therapy is needed to treat bleeding episodes

FEIBA can be used prophylactically to prevent bleeding during ITI and avoid haemophilic arthropathy6-8

  • FEIBA has been a component of the Bonn ITI regimen since its initiation 30 years ago9 and continues to be used in patients at high risk for bleeding4
  • There is evidence that the possible anamnestic response that can be associated with the use of FEIBA may not interfere with efficacy of bleed management10-13
  • ITI with concomitant FEIBA prophylaxis may help reduce bleeds and prevent joint damage when started early12

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.


  1. 1. FEIBA Summary of Product Characteristics 2010.
  2. 2. Brackmann HH, Wallny T. Immune tolerance: high-dose regimen. In: Rodriguez-Merchan EC, Lee CA, eds. Inhibitors in Patients With Hemophilia. Oxford, England: Blackwell Science, Ltd.; 2002:45-48.
  3. 3. Ho AYL, Height SE, Smith MP. Immune tolerance therapy for haemophilia. Drugs. 2000;60(3):547-554.
  4. 4. Brackmann HH, Oldenburg J, Schwaab R. Immune tolerance for the treatment of factor VIII inhibitors—twenty years' 'Bonn protocol'. Vox Sang. 1996;70(suppl 1):30-35.
  5. 5. Leissinger CA. Prevention of bleeds in hemophilia patients with inhibitors: emerging data and clinical direction. Am J Hematol. 2004;77:187-193.
  6. 6. Kreuz W, Escuriola-Ettinghausen C, Mentzer D, Martinez I, Becker S, Stoll H, et al. Factor VIII inhibitor bypass activity (FEIBA) for prophylaxis during immune tolerance induction (ITI) in patients with high-responding inhibitors. Blood 96 (11)266a. Presented at ASH, 42nd Annual Meeting Dec. 1-5, 2000 San Francisco, CA
  7. 7. Valentino LA. The benefits of prophylactic treatment with APCC in patients with haemophilia and high-titre inhibitors: a retrospective case series. Haemophilia. 2009: 15:733-742.
  8. 8. Lambert T, Rothschild C, Goudemand J, Négrier C, Girault S, Moreau P, et al. Secondary Prophylaxis with Activated Prothrombin Complex Concentrates (APCC) Reduces Bleeding Frequency in Haemophilia A Patients with Inhibitors. Poster presented at the XXII Congress of the International Society on Thrombosis and Haemostasis, Boston, Massachusetts, USA, 2009.
  9. 9. Gomperts ED, Astermark J, Gringeri A, Teitel J. From theory to practice: applying current clinical knowledge and treatment strategies to the care of hemophilia A patients with inhibitors. Blood Reviews 2008; 22(Suppl 1), S1-S11.
  10. 10. Ewing N. Anamnestic Responses in Hemophilia Patients with Inhibitors on Continuous Prophylaxis with Factor Eight Inhibitor Bypassing Activity, Vapor Heated (FEIBA VH). J Thromb. Haemost. 2005;3(Suppl 1):abstract P2036.
  11. 11. Luu H, Ewenstein B. FEIBA safety profile in multiple modes of clinical and home-therapy application. Haemophilia. 2004:10(Suppl. 2):10-16
  12. 12. Ettingshausen CE, Kreuz W. Early long-term FEIBA prophylaxis in haemophilia A patients with inhibitor after failing immune tolerance induction: A prospective clinical case series. Haemophilia: 2010: 16:90-100.
  13. 13. Aledort LM. Factor VIII inhibitor bypassing activity (FEIBA)—addressing safety issues. Haemophilia. 2008;14:39-43.

Proven efficacy

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Dosing FEIBA

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Learn how FEIBA prophylaxis may help protect your patients against bleeds. Read more