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FEIBA safety and tolerability profile
Author(s) -
GOMPERTS E. D.
Publication year - 2006
Publication title -
haemophilia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.213
H-Index - 92
eISSN - 1365-2516
pISSN - 1351-8216
DOI - 10.1111/j.1365-2516.2006.01380.x
Subject(s) - medicine , tolerability , dosing , adverse effect , haemophilia , prothrombin complex concentrate , factor ix , intensive care medicine , pediatrics , warfarin , atrial fibrillation
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.