The FEIBA manufacturing process helps ensure patient safety from collection to final product1,9
Integrated, validated, 2-step virus inactivation and removal process
Plasma collected and tested by FDA-approved establishments and procedures
As with all plasma-derived products, the risk of transmission of infectious agents cannot be totally eliminated. As of October 2017, reports from self-reported databases show there have been no confirmed reports of transmission of hepatitis A, B, or C or human immunodeficiency virus (HIV) associated with the use of FEIBA [Anti-Inhibitor Coagulant Complex] since the introduction of vapor heat treatment. Ongoing surveillance indicates that this remains valid.4,7,8
The FEIBA plasma screening and purification processes help to ensure purity and safety9
Plasma screening
Selected Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex]
WARNINGS AND PRECAUTIONS
Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur. Symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. 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 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.
FEIBA contains blood group isohemagglutinins (anti-A and anti-B). Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, D, may interfere with some serological tests for red cell antibodies, such as antiglobulin test (Coombs test).
ADVERSE REACTIONS
Most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.
Serious adverse reactions seen are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.
Mechanism of Action
Multiple clotting factors of FEIBA achieve hemostasis in an in vitro analysis.2
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FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:
Control and prevention of bleeding episodes
Detailed Important Risk Information
WARNING: EMBOLIC and THROMBOTIC EVENTS
Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA,
Indications for FEIBA
FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:
Control and prevention of bleeding episodes
Perioperative management
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
FEIBA is not indicated for the treatment of bleeding episodes resulting from...
Detailed Important Risk Information
WARNING: EMBOLIC and THROMBOTIC EVENTS
Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors.
Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.
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