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FEIBA ® safety profile in multiple modes of clinical and home‐therapy application
Author(s) -
Luu H.,
Ewenstein B.
Publication year - 2004
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.1365-2516.2004.00935.x
Subject(s) - medicine , dosing , haemophilia , adverse effect , factor ix , pharmacovigilance , incidence (geometry) , hepatitis b , haemophilia b , prothrombin complex concentrate , intensive care medicine , orphan drug , haemophilia a , complication , pediatrics , bioinformatics , warfarin , physics , optics , biology , atrial fibrillation
Summary. The development of neutralizing antibodies to factor VIII or IX therapeutic concentrates remains the most serious and challenging complication in the management of patients with haemophilia A and B. FEIBA ® , Anti‐Inhibitor Coagulant Complex, is an activated prothrombin complex concentrate that has been used to treat patients with such complications for almost 30 years. The mechanism of action of FEIBA ® has been proposed to involve simultaneous FVIII/FIX inhibitor bypassing action in the common, intrinsic and extrinsic coagulation pathways. FEIBA ® is derived from human plasma that undergoes stringent viral screening followed by significant viral inactivation and removal. To date, there have been no confirmed reports of transmission of hepatitis A, B or C, or of human immunodeficiency viruses associated with the use of the current, vapour‐heat‐treated FEIBA ® concentrate. The incidence of thrombotic adverse events recorded in the Baxter pharmacovigilance database for the 10‐year postmarket period (1990–99) was approximately 4 : 100 000 infusions of FEIBA ® . Almost all documented thrombotic events with FEIBA ® occurred with doses that exceeded dosing recommendations, and known risk factors for cardiovascular disease were evident in more than 80% of the patients involved. Overall, clinical data have shown FEIBA ® to be safe and well‐tolerated for use in a wide variety of clinical settings, including treatment of bleeding episodes, management of surgical procedures, home therapy, long‐term prophylaxis, and prophylaxis during immune tolerance induction, when used according to dosing guidelines.