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New Recombinant XYNTHA Now Available for Patients with Hemophilia A
Date:9/8/2008

action in study 1 is headache (24% of subjects) and in study 2 is fever (41% of subjects). The most common adverse reactions (greater than or equal to 5% of subjects) in clinical studies were headache, fever, nausea, diarrhea, vomiting, and weakness.

-- Patients may develop hypersensitivity to hamster protein, which is present in trace amounts in XYNTHA.

-- Female patients should be advised to notify their physician if they become pregnant, intend to become pregnant, or are breastfeeding during therapy.

-- Before traveling, patients using XYNTHA should be advised to consult with their health care professional and to bring an adequate supply of XYNTHA for anticipated treatment.

Indication for ReFacto

ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.

Important Safety Information for ReFacto

-- As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions.

-- The remote possibility exists for hypersensitivity to non-human mammalian proteins. Known hypersensitivity to mouse or hamster proteins may be a contraindication to the use of ReFacto.

-- Allergic reactions such as hives, itching, difficulty breathing, rapid heart rate, light-headedness and anaphylaxis have been reported for all factor VIII products. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any of these symptoms occur.

Please see full Prescribing Information for XYNTHA and ReFacto available at http://www.wyeth.com. '/>"/>

SOURCE Wyeth Pharmaceuticals
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