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Feiba

Last reviewed on RxList: 2/5/2018
Feiba Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/5/2018

Feiba (anti-inhibitor coagulant complex) is an anti-inhibitor coagulant complex indicated for use in hemophilia A and B patients with inhibitors for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Common side effects of Feiba include:

The dose of Feiba for control and prevention of bleeding episodes and perioperative management is 50-100 units/kg, frequency determined by the condition. The dose of Feiba for routine prophylaxis is 85 units/kg every other day. Feiba may interact with antifibrinolytics such as tranexamic acid and aminocaproic acid. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Feiba; it is unknown how it might affect a fetus. It is unknown if Feiba passes into breast milk. Consult your doctor before breastfeeding.

Our Feiba (anti-inhibitor coagulant complex) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What is hemophilia? See Answer
Feiba Professional Information

SIDE EFFECTS

The most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.

The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

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
(N=36)
Blood And Lymphatic System Disorders Anemia 2 2 5.6
Gastrointestinal Disorders Diarrhea 2 2 5.6
Nausea 2 2 5.6
Vomiting 2 2 5.6
Investigations Hepatitis B Surface 4 4 11.1
Antibody Positive      
Musculoskeletal And Connective Tissue Disorders Hemarthrosis 5 3 8.3

Post-Marketing Experience

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 entire FDA prescribing information for Feiba (Anti-inhibitor Coagulant Complex for Intravenous Use)

SLIDESHOW

Anemia Symptoms and Signs, Types, Treatment and Causes See Slideshow
Related Resources for Feiba

© Feiba Patient Information is supplied by Cerner Multum, Inc. and Feiba Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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