Important Safety Information|Prescribing Information|Health Care Professionals  

Get to know XYNTHA

An albumin-free recombinant factor VIII product that uses a state-of-the-art purification process.*


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Manufactured by Wyeth Pharmaceuticals Inc.
262356-01 © 2010 Pfizer Inc. All rights reserved.
Marketed by Pfizer Inc.
March 2010
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*XYNTHA is manufactured using Chinese hamster ovary (CHO)
cells grown in an albumin-free culture. 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.

Talk to your health care provider to find out whether XYNTHA may
be right for you.

Need help paying for XYNTHA?
Learn about the Patient Assistance Program.

  

Indication for XYNTHA

XYNTHA 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.
Please see full Prescribing Information.