Survey of More than 600 Patients Treated with Tracleer(R) (bosentan) Reveals Actelion Sure Steps(R) Patient Support Program Provides Valuable Educational I...(wo significant safety concerns:potential...)

Date:12/18/2007

wo significant safety concerns: potential for serious liver injury (including rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring) and high potential for major birth defects. Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter. Pregnancy must be excluded and prevented by two forms of birth control; monthly pregnancy tests should be obtained. Because of these risks, Tracleer is only supplied through a controlled distribution system, the Tracleer Access Program (T.A.P.(R))

About Ventavis(R)

Ventavis(R) (iloprost) is an inhaled formulation of iloprost, a synthetic compound that is structurally similar to prostacyclins -- naturally occurring molecules that cause blood vessels to dilate. Ventavis is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with New York Heart Association (NYHA) Functional Class III or IV. In controlled trials, Ventavis improved a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration.

In clinical studies, common adverse reactions due to Ventavis included vasodilation (flushing), cough, headache, trismus, and insomnia. Serious adverse events reported at a rate of less than 3% included congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure. Vital signs should be monitored while initiating Ventavis. Ventavis should not be initiated in patients with systolic blood pressure less than 85 mm Hg. Stop Ventavis immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension.

About Actelion Pharmaceuticals

Actelion Pharmaceuticals has pioneered research and development in the pulmonary arterial hypertension (PAH) disease area. More than 40,000 PAH patients have been prescribed Actelion's product Tracleer, an orally available dual endothelin receptor ant
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SOURCE Actelion Pharmaceuticals US, Inc. Copyright©2007 PR Newswire. All rights reserved

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