Feiba Vh
- Generic Name: anti-inhibitor coagulant complex, vapor heated
- Brand Name: Feiba VH
Feiba VH(Anti-Inhibitor Coagulant Complex, Vapor Heated ) side effects drug center
Feiba Vh Side Effects Center
What Is Feiba Vh?
Feiba VH (anti-inhibitor coagulant complex [AICC], vapor heated) is made up of proteins normally present in the blood that allow the blood to clot used to treat or prevent bleeding in people with hemophilia and Factor VIII inhibitors.
What Are Side Effects of Feiba Vh?
Common side effects of Feiba VH include:
- headache
- flushing
- pain around the IV needle
- numbness or tingling, especially in your face
Tell your doctor if you experience serious side effects of Feiba VH including:
- an allergic reaction (hives, difficulty breathing, or swelling of your face, lips, tongue, or throat)
- 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
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Dosage for Feiba Vh
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.
What Drugs, Substances, or Supplements Interact with Feiba Vh?
Feiba VH may interact with other drugs that affect bleeding or blood-clotting processes. Tell your doctor all medications and supplements you use.
Feiba Vh During Pregnancy or Breastfeeding
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.
Additional Information
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.
Feiba Vh Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor or seek emergency medical help right away if you have:
- bruising, swelling, or pain around a joint;
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
- signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood or;
- signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.
Common side effects may include:
- anemia;
- nausea, vomiting, diarrhea;
- bruising;
- altered sense of taste; or
- a positive hepatitis B antibody test.
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 )
Feiba Vh 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 | 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
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 Vh (Anti-Inhibitor Coagulant Complex, Vapor Heated )
&Copy; Feiba Vh Patient Information is supplied by Cerner Multum, Inc. and Feiba Vh Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.