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Detailed Important Risk Information
and Full Prescribing Information (PI)

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Community StoriesVanessa S. in Pleasant Hill, MO

My name is Vanessa, and my two-and-a-half-year-old son, Jaiden, was diagnosed with severe hemophilia A from birth. It was very traumatic at first, due to all the information that is coming your way at one time. I knew that hemophilia was a bleeding disorder, but aside from that, I did not know much else. We had never known of this in our family and had to learn a lot; we are still learning a lot.

It was hard for my 9-year-old son, Jordan, to understand, but then I explained that his brother needs medicine-just like he takes medicine for different things. That was enough to explain it in the beginning; now he helps with infusions by singing songs, reading books, or just helping to get supplies together.^a

I think that we are lucky in the fact that we have a great HTC, a loving home health agency, and our family to support us through anything. My husband, Mike, and I take turns infusing. We all know that NOTHING slows down a 2-year-old. We started with ADVATE, and it does a good job when it comes to resolving bleeds.⁴

Vanessa S. Pleasant Hill, MO

^a You should be trained on how to do infusions by your hemophilia treatment center or your doctor. The maximum infusion rate is 10mL/min.

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.