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Detailed Important Risk Information
and Full Prescribing Information (PI)

• Fit for You
  • Flexibility
  • Single-Vial Dosing
  • Mixing
  • Single Vial Dose Finder
• Safety & Efficacy
  • Efficacy
  • Safety
  • Prophylaxis
  • Significant Real-World Experience
  • Extensive Clinical Trials
• Assurance
  • Eliminates Potential Risk of Viral Transmission
  • Evolution of Factor VIII Processing
• Community Stories
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• Trial Program
• FAQs

Community StoriesIrma G. in Pixley, CA

I first learned about ADVATE at a conference I attended. I was not sure if I wanted to change products, because I didn't know much about ADVATE at the time. I talked to our doctor about it and asked for more information. As I began to read through all the material, I asked myself "what product is good for my son?" because for me, as well as the rest of the family, the most important thing is that my son/family member who has hemophilia is well.

I like ADVATE because it is free of blood-based additives.^2-4,a It comes in a very small box and it can be stored up to six months outside the refrigerator.^4,b

Irma G. Pixley, CA

^a There have been no confirmed reports of viral transmissions with recombinant factor VIII therapies.

^b Up to 86°F for up to six months not to exceed expiration date. After storage at room temperature, ADVATE must not be returned to the refrigerator.

ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is a medicine used to replace clotting factor VIII that is missing in people with hemophilia A (also called “classic” hemophilia). ADVATE is used to prevent and control bleeding in people with hemophilia A. Your healthcare provider may give you ADVATE when you have surgery.

ADVATE is not used to treat von Willebrand Disease.

Detailed Important Risk Information for ADVATE

You should not use ADVATE if you are allergic to mice or hamsters or any ingredients in ADVATE.

You should tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines and dietary supplements, have any allergies, including allergies to mice or hamsters, are nursing, are pregnant, or have been told that you have inhibitors to factor VIII.

You can have an allergic reaction to ADVATE. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.

Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

Side effects that have been reported with ADVATE include: cough, sore throat, unusual taste, abdominal pain, diarrhea, nausea/vomiting, headache, fever, dizziness, hot flashes, chills, sweating, joint swelling/aching, itching, hematoma, swelling of legs, runny nose/congestion, and rash.

Call your healthcare provider right away about any side effects that bother you or if your bleeding does not stop after taking ADVATE.

Please see ADVATE full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.