FEIBA VH SUMMARY
FEIBA VH Anti-Inhibitor Coagulant Complex, Vapor Heated (AICC) is a freeze-dried sterile human plasma fraction with Factor VIII inhibitor bypassing activity. In vitro, FEIBA VH AICC shortens the activated partial thromboplastin time (APTT) of plasma containing Factor VIII inhibitor. Factor VIII inhibitor bypassing activity is expressed in arbitrary units. One IMMUNO Unit of activity is defined as that amount of FEIBA VH AICC that shortens the APTT of a high titer Factor VIII inhibitor reference plasma to 50% of the blank value. The product is intended for intravenous administration.
FEIBA VH AICC is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors.
In addition, the use of FEIBA IMMUNO AICC has been described in a few non-hemophiliacs with acquired inhibitors to Factors VIII, XI, and XII8-12. One case has been reported where FEIBA IMMUNO AICC was effective in a patient with von Willebrand's disease with an inhibitor16.
Published Studies Related to Feiba VH (Anti-Inhibitor Coagulant Complex)
Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors. [2011.11.03]
BACKGROUND: Patients with severe hemophilia A and factor VIII inhibitors are at increased risk for serious bleeding complications and progression to end-stage joint disease. Effective strategies to prevent bleeding in such patients have not yet been established... CONCLUSIONS: AICC prophylaxis at the dosage evaluated significantly and safely decreased the frequency of joint and other bleeding events in patients with severe hemophilia A and factor VIII inhibitors. (Funded by Baxter BioScience; Pro-FEIBA ClinicalTrials.gov number, NCT00221195.).
Experience of four UK comprehensive care centres using FEIBA(R) for surgeries in patients with inhibitors. [2011.01]
Increasing evidence indicates that factor VIII (FVIII) inhibitor bypassing agents (FEIBA(R) and NovoSeven(R)) can provide effective peri-operative haemostasis in haemophilia patients with high-responding inhibitors. We report the collected experience of all major and minor surgeries, conducted between December 1998 and September 2008, at four UK haemophilia Comprehensive Care Centres with FEIBA(R) as the first-line bypassing agent in patients with inhibitors...
Assessing the benefits of FEIBA prophylaxis in haemophilia patients with inhibitors. [2010.03]
SUMMARY: Prophylaxis with concentrates of factor VIII has become the standard of care for patients with severe haemophilia A because of its ability to prevent joint and other bleeding events. Recent evidence suggests that the prophylactic use of bypassing therapy--activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII (rFVIIa)--provides similar benefits to haemophilia patients with inhibitors...
Early long-term FEIBA prophylaxis in haemophilia A patients with inhibitor after failing immune tolerance induction: A prospective clinical case series. [2010.01]
Persistent high-titre inhibitors after immune tolerance induction (ITI) increase the risks of haemorrhage and arthropathy, resulting in high morbidity and mortality. Long-term prophylaxis with bypassing agents may avert these risks.
FEIBA prophylaxis in haemophilia patients: a clinical update and treatment recommendations. [2010.01]
In patients with severe haemophilia and inhibitors, regular factor VIII inhibitor bypassing activity (FEIBA) prophylaxis has been shown to reduce the frequency of bleeding by up to 85% and to improve patient quality of life. FEIBA is well tolerated; the incidence of thrombotic events and of allergic reactions is extremely low...
Clinical Trials Related to Feiba VH (Anti-Inhibitor Coagulant Complex)
Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor [Recruiting]
The purpose of the study is to determine the efficacy, safety, and health-related quality of
life benefits with FEIBA NF prophylactic treatment as compared with on-demand treatment. The
study will be conducted globally and will consist of two arms. Eligible subjects will be
randomized to undergo a 12-month period of either prophylactic or on-demand therapy.
Trial of NovoSeven® in Hemophilia - Joint Bleeds [Completed]
This trial is conducted in the United States of America (USA).
This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in
hemophilia patients with inhibitors being treated for joint bleeds.
Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII [Active, not recruiting]
Patients with severe hemophilia and inhibitors can be treated effectively by Activated
Prothrombin Complex Concentrates (APCC, eg. FEIBA) or High dose recombinant factor VIIa
(rFVIIa). Rarely, such patients develop refractoriness to these products for whom therapy
with sequential FEIBA and rFVIIa has been recently suggested.
The impetus for the present report was a hemophilia A patient with high titer inhibitor
(1300BU) who had life threatening hematuria that was resistant to repeated doses of 400µg/kg
rFVIIa up to a cumulative dose of 1200 µg/kg given over 6-9 hours.
Thrombin generation (TG) tested in vitro was consistent with resistance to high
concentrations of rFVIIa but yielded good response to combinations of low doses of
rFVIIa+FEIBA. In a desperate attempt to control the bleeding, concomitant therapy of 25 U/kg
FEIBA and 40µg/kg rFVIIa was infused and resulted in arrest of bleeding within minutes. Over
a span of about one year the patient has been successfully treated by this combination for
more than 200 bleeding episodes in muscles and joints.
The FEIBA NovoSeven Comparative Study [Completed]
FENOC is a prospective, open-label, randomized, cross-over, multi-center study to investigate
and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the
treatment of joint hemorrhages in subjects with severe hemophilia A and inhibitors. The study
is designed as a clinical equivalency trial.
A Prospective, Randomized, Cross-Over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors [Recruiting]
The objective of this study is to assess whether prophylactic therapy with an activated
prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number
of bleeds in patients with hemophilia and persistent high responding inhibitors.
Reports of Suspected Feiba VH (Anti-Inhibitor Coagulant Complex) Side Effects
Treatment Failure (9),
Cerebrovascular Accident (1)