Factor VIII inhibitor bypassing activity (FEIBA) – addressing safety issues
L. M. ALEDORT
Dr Aledort serves as chair of the data monitoring committee and as an educational advisor for Baxter Healthcare Corporation.
Search for more papers by this authorL. M. ALEDORT
Dr Aledort serves as chair of the data monitoring committee and as an educational advisor for Baxter Healthcare Corporation.
Search for more papers by this authorAbstract
Summary. Bypassing therapy is usually necessary to control or prevent bleeding episodes in patients with haemophilia A or B and high-titre inhibitors. Factor VIII inhibitor bypassing activity (FEIBA) has a long history of successful use in the acute, surgical and prophylactic treatment settings, but safety concerns have made some reluctant to administer this bypassing agent. A review of the literature and clinical trial data show that FEIBA has a low prevalence of thrombosis, a low prevalence of anamnesis that does not impact haemostatic efficacy and an excellent record of pathogen safety and clinical tolerability.
References
- 1 Leissinger CA. Prevention of bleeds in hemophilia patients with inhibitors: emerging data and clinical direction. Am J Hematol 2004; 77: 187–93.
- 2 Ho AY, Height SE, Smith MP. Immune tolerance therapy for haemophilia. Drugs 2000; 60: 547–54.
- 3 Astermark J, Donfield SM, DiMichele DM, et al. A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study. Blood 2007; 109: 546–51.
- 4 Hayashi T, Tanaka I, Shima M, et al. Unresponsiveness to factor VIII inhibitor bypassing agents during haemostatic treatment for life-threatening massive bleeding in a patient with haemophilia A and a high responding inhibitor. Haemophilia 2004; 10: 397–400.
- 5 Sieger L, Aledort L. Inhibitor challenges in the paediatric setting. Haemophilia 2006; 12: 106–7.
- 6 Teitel J, Berntorp E, Collins P, et al. A systematic approach to controlling problem bleeds in patients with severe congenital haemophilia A and high-titre inhibitors. Haemophilia 2007; 13: 256–63.
- 7 Varadi K, Schoppmann A, Turecek P Mode of action of FEIBA: applying a cell based model of hemostasis. Baxter Scientific Series No. 5 2006. Westlake Village, CA: Baxter Healthcare Corp.
- 8 DiMichele D, Negrier C. A retrospective postlicensure survey of FEIBA efficacy and safety. Haemophilia 2006; 12: 352–62.
- 9 Hilgartner M, Aledort L, Andes A, Gill J. Efficacy and safety of vapor-heated anti-inhibitor coagulant complex in hemophilia patients. FEIBA Study Group. Transfusion 1990; 30: 626–30.
- 10 Hilgartner MW, Knatterud GL. The use of factor eight inhibitor by-passing activity (FEIBA immuno) product for treatment of bleeding episodes in hemophiliacs with inhibitors. Blood 1983; 61: 36–40.
- 11 Negrier C, Goudemand J, Sultan Y, Bertrand M, Rothschild C, Lauroua P. Multicenter retrospective study on the utilization of FEIBA in France in patients with factor VIII and factor IX inhibitors. French FEIBA Study Group. Factor eight bypassing activity. Thromb Haemost 1997; 77: 1113–9.
- 12 Tjonnfjord 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): 41–5.
- 13 Goudemand J, Group FFS Treatment of bleeding episodes occurring in patients with acquired haemophilia with FEIBA: the French experience. Poster presented at: 26th World Federation of Hematology Congress, 17–21 October 2004, Bangkok, Thailand.
- 14 Holme PA, Brosstad F, Tjonnfjord GE. Acquired haemophilia: management of bleeds and immune therapy to eradicate autoantibodies. Haemophilia 2005; 11: 510–5.
- 15 Sallah S. Treatment of acquired haemophilia with factor eight inhibitor bypassing activity. Haemophilia 2004; 10: 169–73.
- 16 Hilgartner MW, Makipernaa A, DiMichele DM. Long-term FEIBA prophylaxis does not prevent progression of existing joint disease. Haemophilia 2003; 9: 261–8.
- 17 Brackmann HH, Oldenburg J, Schwaab R. Immune tolerance for the treatment of factor VIII inhibitors – twenty years’‘Bonn protocol’. Vox sanguinis 1996; 70(Suppl. 1): 30–5.
- 18 Leissinger CA, Becton DL, Ewing NP, Valentino LA. Prophylactic treatment with activated prothrombin complex concentrate (FEIBA) reduces the frequency of bleeding episodes in paediatric patients with haemophilia A and inhibitors. Haemophilia 2007; 13: 249–55.
- 19 Aledort LM. Comparative thrombotic event incidence after infusion of recombinant factor VIIa versus factor VIII inhibitor bypass activity. J Thromb Haemost 2004; 2: 1700–8.
- 20 Sjamsoedin LJM, Heijnen L, Mauser-Bunschoten EP, et al. The effect of activated prothrombin-complex concentrate (FEIBA) on joint and muscle bleeding in patients with hemophilia A and antibodies to factor VIII. A double-blind clinical trial. N Engl J Med 1981; 305: 717–21.
- 21 Ehrlich HJ, Henzl MJ, Gomperts ED. Safety of factor VIII inhibitor bypass activity (FEIBA): 10-year compilation of thrombotic adverse events. Haemophilia 2002; 8: 83–90.
- 22 FEIBA VH[package insert]. Westlake Village, CA: Baxter Healthcare Corporation, April 2005.
- 23 O’Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 2006; 295: 293–8.
- 24 Sallah S, Isaksen M, Seremetis S, Payne Rojkjaer L. Comparative thrombotic event incidence after infusion of recombinant factor VIIa vs. factor VIII inhibitor bypass activity – a rebuttal. J Thromb Haemost 2005; 3: 820–2.
- 25 Aledort L Comparative thrombotic event incidence after infusion of recombinant factor VIIa vs. factor VIII inhibitor bypass activity – reply to a rebuttal. J Thromb Haemost 2005; 3: 822.
- 26 Schneiderman J, Rubin E, Nugent DJ, Young G. Sequential therapy with activated prothrombin complex concentrates and recombinant FVIIa in patients with severe haemophilia and inhibitors: update of our previous experience. Haemophilia 2007; 13: 244–8.
- 27 DiMichele D. Inhibitors: resolving diagnostic and therapeutic dilemmas. Haemophilia 2002; 8: 280–7.
- 28 Ewing N Anamnestic responses in hemophilia patients with inhibitors on continuous prophylaxis with factor eight inhibitor bypassing activity, vapor heated (FEIBA VH) [abstract]. J Thromb Haemost 2005; 3 (Suppl. 1); abstract P2036.
- 29 Turecek PL, Varadi K, Gritsch H, Schwarz HP. FEIBA: mode of action. Haemophilia 2004; 10(Suppl. 2): 3–9.
- 30 Teitel JM. Recombinant factor VIIa versus aPCCs in haemophiliacs with inhibitors: treatment and cost considerations. Haemophilia 1999; 5(Suppl. 3): 43–9.
- 31 Luu H, Ewenstein B. FEIBA safety profile in multiple modes of clinical and home-therapy application. Haemophilia 2004; 10(Suppl. 2): 10–6.
- 32 Dargaud Y, Negrier C. Haemophilia therapies. Expert Opinion Biol Ther 2007; 7: 651–63.
- 33 Dorner F, Barrett N. Viral inactivation and partitioning in the manufacture of coagulation factor concentrates. Hamostaseologie 1996; 16: 282–5.
- 34 Data on file. Westlake Village, CA: Baxter Healthcare Corp.