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Detailed Important Risk Information
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Community StoriesElizabeth S. in Stockton, CA

Ryan was born five weeks earlier than expected. Ryan was born via C-section and was in the NICU for five weeks. Then, when he turned four months old, he suffered a seizure, and an ambulance was called. We were taken to the nearby hospital, and I was told that Ryan was bleeding internally in his head. We were transported to the UC Davis hospital immediately, and it was there where he was diagnosed with severe hemophilia type A. We were told that a blood vessel in his head had erupted, causing a severe bleed inside his head and that Ryan would most likely have problems with walking, talking, and that it would affect his vision also.

As you can imagine, we were devastated; my husband, Christian, and I were not familiar with the disorder, which made it even more overwhelming. The nurse from the UC Davis Hemophilia Clinic came and gave us an overview of hemophilia and the different treatment options. She also gave us a 250-page book to read called The Hemophilia Handbook (Hemophilia of Georgia, Inc., 2007). We learned how serious and dangerous a bleed in the brain could be. We put him on physical therapy, occupational therapy, and speech therapy. He is currently walking, his vision is strong, and we are working with a speech therapist. I bought my son a therapeutic helmet and even made him padded tights to wear underneath his clothes for when he started crawling and walking. I believe he should have a normal life as long as we take precautions. Other than that he is a healthy little boy.

Ever since Ryan was diagnosed, I have made it my goal to learn everything I can about hemophilia. One of the ways that I've tried to do this is by getting actively involved in the hemophilia community. My family has been a member of the National Hemophilia Foundation and the Central California Hemophilia Foundation for two years. Through an amazing social worker, Carmen, we founded the first bilingual group for parents who do not speak English. This group educates us about hemophilia, treatment, health, and most importantly, creates a support system among parents.

I asked the hematologist to give Ryan ADVATE but was denied because they said the hospital would not cover it. However, I was later transferred to Kaiser Permanente in Sacramento where I spoke with a different hematologist. I explained my concerns to him and he agreed to put Ryan on ADVATE.

I like ADVATE because it takes a worry off my shoulders. I don’t worry about having to store it in the refrigerator.^a I still worry that Ryan might fall, or that he will have another spontaneous bleed in his head—that alone is enough to worry about. It is still very hard for me to leave Ryan in someone else’s care. But, in terms of Ryan’s therapy, I rely on ADVATE.

Elizabeth S. Stockton, CA

^a Up to 86° F for up to six months, not to exceed printed 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.