FEIBA VH [Anti-inhibitor Coagulant Complex]
Instructions for Use (Rx Only)
The information contained in this page is intended for U.S. healthcare professionals only.
FEIBA VH therapy is an anti-inhibitor coagulant complex (AICC) with 30 years of experience in the management of hemophilia patients with inhibitors. 1
Indications
FEIBA VH is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors.1
Features
- FEIBA VH therapy works with a unique mechanism of action, making it an integral part of inhibitor management1,2
- FEIBA VH therapy provides both prothrombin (FII) and FXa at the site of the bleed to help ensure a fast, effective response while fostering strong clot formation2
- FEIBA VH therapy bypasses the need for FVIIIa and FIXa, to facilitate hemostasis2
- FII and FXa are the primary contributors to the action of FEIBA VH therapy, promoting thrombin generation on the back of the activated platelet to form the clot2
Safety and Efficacy1
- Trusted for over 30 years, FEIBA therapy has demonstrated tolerability and efficacy.
- FEIBA therapy controlled bleeding in 93% (153/165) of episodes in a multiclinic prospective study (N=49)
- In 78% (130/165) of episodes, hemostasis was achieved with one or more infusions within 36 hours
- 36% (60/165 episodes) were controlled with one infusion within 12 hours
Confidence and Convenience1
- Up to 12 hours ( 6 or 12 hours) between doses
- Convenient room temperature storage
- FEIBA VH therapy comes packaged with BAXJECT Needle-less Transfer Device for safer, faster, and easier reconstitution as compared to needles: needle-less, fewer total steps, one piece design
FEIBA VH Detailed Risk Information
FEIBA VH is contraindicated in patients known to have a normal coagulation mechanism.
FEIBA VH is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses and theoretically the Creutzfeldt-Jakob disease (CJD) agent.
Allergic reactions ranging from mild, short-term urticarial rashes to severe anaphylactoid reactions have been observed. Administration of FEIBA VH should be discontinued immediately if such signs appear.
Thromboembolic events are a rare but well recognized potential complication of FEIBA infusion, particularly following administration of high doses and/or in patients with thrombotic risk factors.
Myocardial infarction was found to occur after high doses and/or prolonged administration and/or in the presence of risk factors.
FEIBA VH should not be used for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors. It should not be given to patients with significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis.
Infusion of FEIBA VH 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 VH must be monitored for the development of DIC and/or symptoms of acute coronary ischemia. High doses of FEIBA VH should be given only as long as absolutely necessary to stop bleeding.
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 VH 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.
Myocardial infarction, disseminated intravascular coagulopathy, injection site pain, anaphylactic reaction, hypersensitivity, urticaria, blood pressure decreased, hypoaesthesia, hypoaesthesia facial, and embolism have been reported in the postmarketing setting. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Disposal and Recycling
After using FEIBA VH, dispose of the empty vial, reconstitution device and syringe in a Sharps container.
References
1. FEIBA VH Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; April 2005.
2. Turecek PL, Varadi K, Gritsch H, et al. Factor Xa and prothrombin: mechanism of action of FEIBA. Vox Sang. 1999; 77(suppl 1):72-79.
