FEIBA NF [Anti-Inhibitor Coagulant Complex] Nanofiltered and Vapor Heated
The information contained in this page is intended for U.S. healthcare professionals only.
FEIBA NF is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors.1
Clinical experience suggests that patients with Factor VIII inhibitor titer of less than 5 B.U. may be successfully treated with Antihemophilic Factor. Patients with titers ranging between 5 and 10 B.U. may either be treated with Antihemophilic Factor or FEIBA NF. Cases with Factor VIII inhibitor titers greater than 10 B.U. have generally been refractory to treatment with Antihemophilic Factor.1
Important Risk Information for FEIBA NF
Thrombotic and thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA VH or FEIBA NF, particularly following the administration of high doses and/or in patients with thrombotic risk factors.
The use of FEIBA NF is contraindicated:
- in patients who have known anaphylactic or severe hypersensitivity reactions to the product
- in patients who are known to have a normal coagulation mechanism
- for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX
- in patients with significant signs of disseminated intravascular coagulation (DIC)
- In patients with acute thrombosis or embolism (including myocardial infarction)
At first sign or symptoms of an infusion/hypersensitivity reaction or a thrombotic/thromboembolic event, FEIBA NF administration should be stopped immediately and diagnostic and therapeutic measures initiated as appropriate.
Allergic-type hypersensitivity reactions, including severe anaphylactoid reactions, have been reported following the infusion of FEIBA. The symptoms include urticaria, angiodema, gastrointestinal manifestations, bronchospasms, and hypotension; these reactions can be severe and can be systemic.
Many of the reported cases of thromboembolic events occurred with doses above 200 units/kg/day or in patients with other risk factors.
Infusion of FEIBA NF should not exceed single dosage of 100 U/kg and daily doses of 200 U/kg of body weight. Patients receiving more than 100 U/kg of FEIBA NF must be monitored for the development of DIC and/or symptoms of acute coronary ischemia. High doses of FEIBA NF should be given only as long as absolutely necessary to stop bleeding.
FEIBA VH or FEIBA NF should be used with particular caution and only if there are no therapeutic alternatives in patients at risk of DIC, arterial or venous thrombosis.
If clinical signs of intravascular coagulation occur, which include changes in blood pressure, changes in pulse rate, respiratory distress, chest pain and/or cough, infusion of FEIBA NF should be stopped promptly.
Non-hemophilic patients with acquired inhibitors against factors VIII, IX or XII may have both a bleeding tendency and an increased risk of thrombosis at the same time.
FEIBA NF is made from human plasma and may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent.
Adverse reactions reported in clinical studies with FEIBA were anamnestic response, somnolence, dizziness, dysgeusia, dyspnea, hypoesthesia, nausea, chills, pyrexia, chest pain and chest discomfort.
Disposal and Recycling
After using FEIBA NF, dispose of the empty vial, reconstitution device and syringe in a Sharps container.
1. FEIBA NF Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; February 2011.