FEIBA safety and tolerability profile

Author: GOMPERTS, E. D.

Source: Haemophilia, Volume 12, Supplement 5, December 2006 , pp. 14-19(6)

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Abstract:

Summary.

The activated prothrombin complex concentrate, FEIBA, has been used for more than 30 years to treat or prevent bleeding episodes in haemophilia patients with high-titre alloantibodies or individuals with autoantibodies to factor VIII. Rigorous plasma screening combined with robust viral inactivation and removal have enhanced the viral safety of the current commercially available FEIBA vapour-heated formulation and minimized the risk of pathogen transmission associated with plasma-derived therapeutics. Furthermore, when FEIBA is used according to the recommended dosing guidelines, clinical data show it is safe and well tolerated and has a very low risk of thrombotic adverse events.

Keywords: bypassing therapy; clinical safety; FEIBA; hemophilia A and B; viral safety

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1365-2516.2006.01380.x

Publication date: 2006-12-01