Important Safety Information for XYNTHA

• Call your healthcare provider or go to the emergency department right away if you have any of the following symptoms because these may be signs of a serious allergic reaction: wheezing, difficulty breathing, chest tightness, turning blue (look at lips and gums), fast heartbeat, swelling of the face, faintness, rash, low blood pressure, or hives. XYNTHA contains trace amounts of hamster protein. You may develop an allergic reaction to these proteins. Tell your healthcare provider if you have had an allergic reaction to hamster protein
• Call your healthcare provider right away if bleeding is not controlled after using XYNTHA; this may be a sign of an inhibitor, an antibody that may stop XYNTHA from working properly. Your healthcare provider may need to take blood tests to monitor for inhibitors
• Across all clinical studies, the most common side effects (10% or more) with XYNTHA in adult and pediatric previously treated patients (PTPs) were headache (26% of subjects), joint pain (25%), fever (21%), and cough (11%). Other side effects reported in 5% or more of patients were: diarrhea, vomiting, weakness, and nausea
• XYNTHA is an injectable medicine administered by intravenous (IV) infusion. You may experience local irritation when infusing XYNTHA after reconstitution in XYNTHA^® SOLOFUSE^®.

What is XYNTHA?

XYNTHA^® Antihemophilic Factor (Recombinant) is indicated in adults and children for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for the prevention of bleeding during surgery in patients with hemophilia A.

XYNTHA does not contain von Willebrand factor and, therefore, is not indicated for von Willebrand’s disease.

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.