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.
|
NEWS HIGHLIGHTS
Published Studies Related to Feiba VH (Anti-Inhibitor Coagulant Complex)
Factor eight inhibitor bypassing activity (FEIBA) for refractory bleeding in cardiac surgery: review of clinical outcomes. [2008.11]
BACKGROUND: Refractory postoperative bleeding complicates a significant number of cardiac surgical procedures and results in both morbidity and mortality. Conventional strategies to effect hemostasis include surgical reexploration and administration of blood products. In some cases, bleeding remains intractable despite these methods, and alternatives are needed. Herein, we report our experience with the use of factor eight inhibitor bypassing activity (FEIBA), a coagulation factor concentrate, for refractory postoperative bleeding... CONCLUSIONS: FEIBA administration is associated with decreased blood product utilization and chest tube output in patients with refractory postoperative bleeding.
Factor VIII inhibitor bypassing activity (FEIBA) - addressing safety issues. [2008.01]
Bypassing therapy is usually necessary to control or prevent bleeding episodes in patients with haemophilia A or B and high-titre inhibitors.A review of the literature and clinical trial data show that FEIBA has a low prevalence of thrombosis, a low prevalence of anamnesis that does not impact haemostatic efficacy and an excellent record of pathogen safety and clinical tolerability.
Factor VIII inhibitor bypassing activity (FEIBA) - addressing safety issues. [2007.10.23]
Bypassing therapy is usually necessary to control or prevent bleeding episodes in patients with haemophilia A or B and high-titre inhibitors.A review of the literature and clinical trial data show that FEIBA has a low prevalence of thrombosis, a low prevalence of anamnesis that does not impact haemostatic efficacy and an excellent record of pathogen safety and clinical tolerability.
Prophylactic treatment with activated prothrombin complex concentrate (FEIBA) reduces the frequency of bleeding episodes in paediatric patients with haemophilia A and inhibitors. [2007.05]
Orthopaedic complications are among the most disabling sequelae occurring in patients with haemophilia and inhibitors...
Use of FEIBA for invasive or surgical procedures in patients with severe hemophilia A or B with inhibitors. [2007.04]
Achieving hemostasis in patients with hemophilia A or B is complicated by the presence of inhibitors and is made even more difficult when these individuals require surgery. Over a 4-year period, 6 patients with inhibitors to factor VIII and 1 patient with inhibitors to factor IX underwent surgery or invasive procedures at our institution...
Clinical Trials Related to Feiba VH (Anti-Inhibitor Coagulant Complex)
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.
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.
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.
|
