The adverse reactions presented as follows have been reported from post-marketing surveillance as well as from 2 studies with FEIBA for the treatment of bleeding episodes in pediatric and adult patients with hemophilia A or B and inhibitors to factors VIII or IX. One study also enrolled acquired hemophilia patients with factor VIII inhibitors (2 of 49 patients). The adverse reactions from a third study comparing prophylaxis with on-demand treatment have been added.
Frequency categories are defined according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (cannot be estimated from the available data). (See table.)
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Class Reactions: Other symptoms of hypersensitivity reactions to plasma-derived products include lethargy and restlessness.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of FEIBA is important. It allows continued monitoring of the benefit/risk balance of FEIBA. Healthcare professionals are asked to report any suspected adverse reactions.
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