What Is XYNTHA?

Xyntha® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.

XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease.

Important Safety Information for XYNTHA

  • Allergic reactions are possible with XYNTHA. Signs of an allergic reaction may include hives, rash with itching, chest tightness, difficulty breathing, faintness, or fast heartbeat. XYNTHA contains trace amounts of hamster protein. You may develop an allergic reaction to these proteins. Tell your doctor if you have had an allergic reaction to hamster protein.
  • Call your doctor right away if bleeding is not controlled after using your factor VIII replacement therapy; this may be a sign of an inhibitor. Inhibitors have been observed in patients receiving factor VIII products, including XYNTHA.
  • The most common adverse reaction in study 1 (safety and efficacy study) is headache (24% of subjects) and in study 2 (surgery study) is fever (41% of subjects). Other common side effects of XYNTHA include nausea, vomiting, diarrhea, or weakness.
  • XYNTHA is an injectable medicine administered by intravenous (IV) infusion.
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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.

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Manufactured by Wyeth Pharmaceuticals Inc.
© 2011 Pfizer Inc. All rights reserved.
Marketed by Pfizer Inc.
June 2011
RUS288549-01
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