Pfizer is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted approval for the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is an injectable recombinant factor VIII product previously approved by the FDA for both the control and prevention of bleeding episodes and surgical prophylaxis in patients with hemophilia A. XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand’s disease.
The approval of the Prefilled Dual-Chamber Syringe is an important milestone for hemophilia patients due to its innovative, convenient reconstitution system that eliminates the transfer step. Pfizer is committed to the hemophilia community not only through the development of novel reconstitution systems focusing on convenience, such as the XYNTHA Prefilled Dual-Chamber Syringe, but also through early clinical research of other proteins, including Factor Xa and Factor VIIa.
“Because I strive to lead an active life, I am excited by the approval of the Prefilled Dual-Chamber Syringe that eliminates the transfer step,” said Christian, a Pfizer Lifeline’s Ambassador and hemophilia A patient. “I look forward to being able to use a device that has one less step when I reconstitute my XYNTHA.”
We encourage you to review the press release below, announcing the approval of the Prefilled Dual-Chamber Syringe, for full information. The release was issued to the general public over Business Wire on August 9, 2010.
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.
- Please see accompanying Full Prescribing Information. (6528) W10547C001 ET01 (CLEAN PHYSICIAN) FACTOR VIII AF RECOMBINANT