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Indications:
ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is indicated in hemophilia A (classical hemophilia) for the control and prevention of bleeding episodes and for perioperative management of adults and children with hemophilia A.
ADVATE is not indicated for the treatment of von Willebrand’s disease.
Important Safety Information:
Let your doctor know if you have had any previous allergic reactions to other factor VIII products or mouse or hamster proteins.
There is a possibility that you can have an allergic reaction to ADVATE. Symptoms of an allergic reaction may include rash, hives, itching, tightness in throat or chest, difficulty breathing, feeling dizzy or light-headed, or a weak pulse. Anaphylaxis, a severe and potentially life-threatening allergic reaction, is possible. If you experience any of these symptoms, stop the infusion immediately and promptly contact your doctor.
The formation of inhibitors has been observed with all factor VIII products, including ADVATE. Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of factor VIII therapy.
The most serious adverse reactions seen with ADVATE are chest pain and fever. The most common adverse reactions observed include nausea and vomiting, upper respiratory-type infection, fever, accident and injury, joint pain and swelling, headache, limb pain, and cough.
ADVATE Full Prescribing Information (PDF).
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