May 24, 2016
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Bioclate Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Bioclate (antihemophilic factor [recombinant]) is a glyco-protein used in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. It is also indicated in the perioperative management of patients with hemophilia A. This medication may be available in generic form. Common side effects include nausea, fatigue, nosebleeds, fever, chills, or hives.

Dosage of Bioclate is determined by a physician and is individualized for the patient. Bioclate may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Bioclate should be used only if prescribed. Consult your doctor before breastfeeding.

Our Bioclate (antihemophilic factor [recombinant]) 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 Prescribing information?

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

Bioclate FDA Prescribing Information: Side Effects
(Adverse Reactions)


During the clinical studies conducted in the previously treated patient group, there were 13 infusion related minor adverse reactions reported out of 13,394 infusions (0.097%). One patient experienced flushing and nausea during his first infusion which abated on decreasing the infusion rate. A second patient experienced mild fatigue during and following one infusion and the third patient had a series of eleven nose bleeds with a periodicity associated with the infusions.

The protein in greatest concentration in Antihemophilic Factor (Recombinant) Bioclate (antihemophilic factor) is Albumin (Human). Reactions associated with intravenous administration of albumin are extremely rare, although nausea, fever, chills or urticaria have been reported. Other allergic reactions could theoretically be encountered in the use of this Antihemophilic Factor preparation. See PATIENT INFORMATION.

Read the entire FDA prescribing information for Bioclate (Antihemophilic Factor)

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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