Mechanism of Action
Acts on 3 pathways in the clotting cascade to facilitate coagulation in an in vitro analysis
- FEIBA contains additional factors that target multiple sites within the coagulation system. FEIBA contains mainly non-activated forms of factors II, IX, X, and mainly activated factor VII
- Provides both FII (prothrombin) and FXa for thrombin generation
- Peak thrombin generation at 15 to 30 minutes in an in vitro assay14
- Thrombin generation returns to baseline value 8 to 12 hours after a single dose of FEIBA14
Selected Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex]
WARNING: THROMBOEMBOLIC EVENTS
- Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors.
- Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.
Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. These reactions can be severe and systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA and provide appropriate supportive care.
Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.