XYNTHA has been studied, tested, and proven to work in clinical trials. The clinical trials looked at previously treated patients (PTPs) who have severe to moderately severe hemophilia A.

When needed

Inhibitor information

There is a risk of developing inhibitors with any factor VIII product. In a clinical trial, of 89 evaluable subjects with >50 exposure days, 2 subjects experienced inhibitors. These results were consistent with the study goal that no more than 2 inhibitors could be detected in a study group that included at least 81 subjects.
  • Subjects rated first infusion outcomes as excellent or good (70.6%) or moderate (24.1%); no response (2.7%); not rated (2.7%).
  • Subjects experienced a mean of <4 bleeds per year (median annualized bleeding rate of 1.9).

Study 1: Open-label study of PTPs (mean age, 27.7 years; range 12-60 years) with severe or moderately severe hemophilia A (FVIII:C ≤2%; ≥150 previous exposure days) given XYNTHA 3 times per week (30 ± 5 IU/kg; N=94) and on demand (investigator-determined dose; n=53 [187 bleeding episodes]). Results reported here for 3 times per week administration are based on 89 patients accruing ≥50 exposure days to XYNTHA.

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