Wyeth's XYNTHA Approved by FDA for Treatment of He...(a rare inherited blood-clotting disorder...),Health

Date:2/21/2008

a rare, inherited blood-clotting disorder. People with hemophilia A are deficient in a key protein -- factor VIII -- which is vital in the clotting mechanism to prevent bleeding. Hemophilia A can be characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. Most patients with hemophilia A are dependent on factor VIII replacement therapy.

Indication

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

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

Important Safety Information

-- Allergic type hypersensitivity reactions are possible. Patients should

be informed of the early signs or symptoms of hypersensitivity

reactions (including hives (rash with itching), generalized urticaria,

tightness of the chest, wheezing, and hypotension) and anaphylaxis.

Patients should be advised to discontinue use of the product and

contact their physicians if these symptoms occur.

-- Inhibitors have been detected in patients receiving factor VIII-

containing products. In a pivotal phase 3 study, two of 89 patients

(2.2 percent) who completed greater than or equal to 50 exposure days

developed factor VIII inhibitor. These results were consistent with

the pre-specified endpoint of the study. Patients using coagulation

factor VIII products, including XYNTHA, should be monitored for the

development of factor VIII inhibitors. If expected factor VIII

activity plasma levels are not attained, or if bleeding is not

controlled with an appropriate dose, an assay should be performed to

determine if
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SOURCE Wyeth Pharmaceuticals Copyright©2008 PR Newswire. All rights reserved

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