July 26, 2016
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Feiba Vh

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Feiba VH

Feiba Vh Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Feiba VH (anti-inhibitor coagulant complex [AICC], vapor heated) is used to treat or prevent bleeding in people with hemophilia and Factor VIII inhibitors. It is made up of proteins normally present in the blood that allow the blood to clot. Common side effects include headache, or flushing.

As a general guideline, a dosage range of 50 to 100 Units of Feiba VH per kg of body weight is recommended. A physician will determine dose depending on different types of hemorrhage. Feiba VH may interact with other drugs that affect bleeding or blood-clotting processes. Tell your doctor all medications and supplements you use. During pregnancy, Feiba VH should be used only if prescribed. It is unknown if it will harm a fetus. It is unknown if this drug could be harmful to a nursing baby. Consult your doctor before breastfeeding.

Our Feiba VH (anti-inhibitor coagulant complex, vapor heated) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Feiba Vh in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), feeling like you might pass out;
  • fever, chills, runny nose, and drowsiness, followed by rash and joint pain about 2 weeks later;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • pain, swelling, warmth, or redness in one or both legs;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • fast or slow heart rate, weak pulse, trouble breathing, chest pain or cough; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • pain around the IV needle or
  • numbness or tingling, especially in your face.

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.

Read the entire detailed patient monograph for Feiba Vh (Anti-Inhibitor Coagulant Complex, Vapor Heated )

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Feiba Vh Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Feiba Vh (Anti-Inhibitor Coagulant Complex, Vapor Heated )

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Feiba Vh FDA Prescribing Information: Side Effects
(Adverse Reactions)


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
Blood And Lymphatic System Disorders Anemia 2 2 5.6
Gastrointestinal Diarrhea 2 2 5.6
Disorders Nausea 2 2 5.6
  Vomiting 2 2 5.6
Investigations Hepatitis B Surface Antibody Positive 4 4 11.1
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




GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: malaise, feeling hot, injection site pain

Read the entire FDA prescribing information for Feiba Vh (Anti-Inhibitor Coagulant Complex, Vapor Heated )

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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