Source: Health Products Regulatory Authority (IE) Revision Year: 2011 Publisher: Baxter Healthcare Limited, Caxton Way, Thetford, IP243 SE, Norfolk, United Kingdom
Pharmacotherapeutic group: blood coagulation factors
ATC code: B02BD03
Although FEIBA was developed in the early seventies and its factor VIII inhibitor bypassing activity has been proven in vitro as well as in vivo, its mode of action is still the subject of scientific discussion.
Current scientific works point to the role of specific components of the activated prothrombin complex, prothrombin (F II) and activated factor X (FXa) in the mode of action of FEIBA.
The experience in hemophilia Β patients with factor IX inhibitor is limited. 40 case reports are available when FEIBA was used for treatment and prevention of bleeding episodes in hemophilia Β patients with factor IX inhibitor. 3 of these 40 patients experienced anaphylactic reaction during treatment.
There are also isolated reports on the use of FEIBA in the treatment of patients with acquired inhibitors to factors X, XI and XIII.
As the mode of action of FEIBA is still being discussed, it is not possible to make a conclusive statement about the pharmacokinetic properties.
Based on acute toxicity studies in factor VIII knockout mice and in normal mice, and in rats, with doses higher than the maximum daily dose in humans (>200 U/kg body weight), it can be concluded that the side effects in connection with FEIBA are mainly the result of hypercoagulation due to the pharmacological properties.
Toxicity studies with repeated administration in animal experiments are practically unfeasible as interference occurs through the development of antibodies to heterologous proteins.
Since human blood coagulation factors are not seen as carcinogenic or mutagenic, experimental animal studies, especially in heterologous species, were not considered necessary.
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