ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]

The information contained in this page is intended for U.S. healthcare professionals only.

Indications

ADVATE is indicated in hemophilia A (classical hemophilia) for the control and prevention of bleeding episodes and perioperative management in adults and children with hemophilia A. ADVATE is not indicated for the treatment of von Willebrand's disease.1

Important Risk Information for ADVATE

ADVATE is contraindicated in patients with known anaphylaxis to mouse or hamster protein or other constituents of the product.

Allergic-type hypersensitivity reactions, including anaphylaxis, are possible and have been reported with ADVATE. Symptoms have manifested as dizziness, paresthesia, rash, flushing, face swelling, urticaria, dyspnea, and pruritis. Discontinue use if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Patients treated with AHF products should be monitored for the development of factor VIII inhibitors. Inhibitors have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs).

If expected plasma factor VIII levels are not attained, or if bleeding is not controlled with an expected dose, test for the presence of inhibitors.

The most serious adverse reactions seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

The most common adverse reactions observed in clinical trials (frequency ≥2% of subjects) were factor VIII inhibitor formation (observed predominantly in PUPs) and headache.

Disposal and Recycling

After using ADVATE, dispose of the empty vial, reconstitution device and syringe in a Sharps container.

References

1. ADVATE Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; March 2010.

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