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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety assessment of FEIBA is based on the review of the data from two prospective clinical trials in which FEIBA was used for the treatment of acute bleeding episodes and a prospective trial that compared the use of FEIBA prophylactically versus on-demand treatment.
The adverse reactions reported from two prospective clinical trials in which FEIBA was used for the treatment of acute bleeding episodes were chills, chest pain, chest discomfort, dizziness, dysgeusia, dyspnea, hypoesthesia, increase of inhibitor titer (anamnestic response), nausea, pyrexia, and somnolence. Specifically, the first trial was a multicenter randomized, double-blind trial in 15 hemophilia A subjects with inhibitors to factors VIII. The second trial was a multicenter FEIBA study conducted in 44 hemophilia A subjects with inhibitors, 3 hemophilia B subjects with inhibitors and 2 acquired factor VIII inhibitor subjects. Of the 489 infusions used to treat acute bleeds during the second trial, 18 (3.7%) caused minor transient reactions of chills, fever, nausea, dizziness and dysgeusia. Out of 49 subjects, 10 (20%) had a rise in their inhibitor titers after treatment with FEIBA. Five of these subjects (50%) had increases that were, tenfold or more, and 3 (30%) of these subjects received factor VIII or IX concentrates within 2 weeks prior to treatment with FEIBA. These anamnestic rises were not associated with decreased efficacy of FEIBA.
Table 2 lists the adverse reactions in > 5% of subject reported in the randomized, prospective prophylaxis trial comparing FEIBA prophylaxis with on-demand treatment in 36 hemophilia A and B subjects with inhibitors to factors VIII or IX3. The trial population included 33 (92%) subjects with hemophilia A and 3 (8.3%) subjects with hemophilia B. Four (11%) subjects were ≥ 7 to < 12 years of age, 5 (14%) were ≥ 12 to < 16 years of age, and 27 (75%) were ≥ 16 years of age. A total of 29 (80.6%) subjects were Caucasian, 3 (8.3%) Asian, 2 (5.6%) Black/African American, and 2 (5.6%) other. The subjects received a total of 4,513 infusions (3,131 for prophylaxis and 1,382 for on-demand). Adverse reactions were defined as adverse events that occurred (a) within 24 hours after being infused or (b) adverse events assessed related or possibly related or (c) adverse events for which the investigator's or sponsor's opinion of causality was missing or indeterminate.
Table 2 : Prophylaxis Study Adverse Reactions (ARs) in
> 5% of Subjects
|MedDRA System Organ Class||Preferred Term||Number of ARs||Number of Subjects||Percent of Subjects
|Blood And Lymphatic System Disorders||Anemia||2||2||5.6|
|Investigations||Hepatitis B Surface Antibody Positive||4||4||11.1|
|Musculoskeletal And Connective Tissue Disorders||Hemarthrosis||5||3||8.3|
Because post-marketing reporting of adverse reactions is voluntarily and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.
BLOOD AND LYMPHATIC SYSTEM DISORDERS: disseminated intravascular coagulation
CARDIAC DISORDERS: tachycardia, flushing
RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: bronchospasm, wheezing
GASTROINTESTINAL DISORDERS: abdominal discomfort
SKIN AND SUBCUTANEOUS TISSUE DISORDERS: pruritus
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: malaise, feeling hot, injection site pain
Read the Feiba VH (anti-inhibitor coagulant complex, vapor heated) Side Effects Center for a complete guide to possible side effects
Consider the possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used during treatment with FEIBA. No adequate and wellcontrolled studies of the combined or sequential use of FEIBA and recombinant factor VIIa or antifibrinolytics have been conducted. Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.
3. Antunes SV, Tangada S, Stasyshyn O, Mamonov V, Phillips J, Guzman-Becerra N, Grigorian A, Ewenstein B, Wong WY. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors. Haemophilia. 2013; DOI 10.1111/ hae.12246.
Read the Feiba VH Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/7/2016
Additional Feiba VH Information
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