Feiba Adverse Reactions

Factor VIII Inhibitor Bypassing Activity (Feiba) can precipitate allergic-type hypersensitivity reactions that have included urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and a drop in blood pressure; these reactions can be severe and can be systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). See Hypersensitivity Reactions under Warnings.
The adverse reactions presented in this section have been reported from post marketing surveillance as well as from 2 studies with Factor VIII Inhibitor Bypassing Activity (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 Factor VIII Inhibitor Bypassing Activity (Feiba) is important. It allows continued monitoring of the benefit/risk balance of Factor VIII Inhibitor Bypassing Activity (Feiba). Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.