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Detailed Important Risk Information
and Full Prescribing Information (PI)

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• FAQs

Safety & Efficacy Inhibitor Development Profile From Clinical Studies⁶

Guidelines suggest that the risk for inhibitors related to an individual product should be evaluated in PTPs.¹⁴

• One person out of 198 PTPs in clinical trials developed a low-titer inhibitor that was no longer detectable eight weeks later.^4,6,a-d
• The formation of inhibitors has been observed with all factor VIII products, including ADVATE.

Inhibitor Rates From Clinical Studies in PTPs^4,6,7

^a The rate [95% safety-and-efficacy interval] for developing an inhibitor in PTPs (factor VIII ≤2%) was 0.51% [0.03%-2.91%] based on completed study analysis.^6
b Patients with an estimated ≥150 factor VIII exposure days.
^c Some patients participated in more than one study.
^d Patients with an estimated ≥50 factor VIII exposure days.

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.