TRACLEER TREATMENT

Tracleer (Bosentan) made by Actelion was one of the first available oral forms of prostacyclin. It has been made available for clinical trials and is a hopeful candidate for FDA approval for treatment of PPH.

Tracleer belongs to a class of drugs known as endothelin receptor antagonists (ERAs). Tracleer works by blocking the action of a hormone called endothelin. Endothelin exists in higher levels in people with PPH and is harmful to the lung and pulmonary arteries because it narrows blood vessels and elevates blood pressure. The damaged lung and pulmonary arteries create the blood flow resistance that results in hypertension. Tracleer was designed to offset endothelin, reversing its effects and resulting in lower arterial pressure.

The FDA with the help of the Cardiovascular and Renal Drugs Advisory Committee determined that Tracleer is an effective treatment (for pulmonary arterial hypertension, or PAH) based on the results of two randomized, placebo-controlled clinical trials involving a total of 245 patients. Patients receiving Tracleer were able to walk statistically significantly longer distances in the six-minute walk test after 16 weeks, compared to the placebo.

The use of Tracleer requires attention to two significant risks: liver toxicity and the drug's potential to damage a fetus. In order to ensure careful attention to monitoring for these risks, Tracleer will be available only through a direct distribution program from the drug's manufacturer, Actelion Pharmaceuticals US, Inc., of South San Francisco, Calif. It will not be available in commercial pharmacies.

These safety issues are highlighted in a black box warning in the drug's labeling for health professionals and explained in a Medication Guide for patients. The black box information warns that liver enzyme levels must be measured before initiation of treatment with Tracleer and monthly thereafter to avoid serious liver injury. To date, the elevation of liver enzymes caused by Tracleer has been resolved without causing permanent liver damage.

Because of its potential to cause birth defects, Tracleer must not be prescribed to pregnant women. Female patients of childbearing potential must take measures to prevent pregnancy, and monthly pregnancy testing is required. Oral, injected and implanted contraceptives may not be reliable, as Tracleer may interfere with their effectiveness. Female patients should consult with a gynecologist before use.

What are the Side effects of Tracleer?

Adverse reactions reported in clinical testing of Tracleer include (but are not limited to) the following:

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