Switzerland's Actelion has launched its orally-active endothelinreceptor antagonist Tracleer (bosentan) for the treatment of pulmonary arterial hypertension in the USA, its first market. PAH is a chronic, life-threatening disorder that can severely compromise the function of the lungs and heart. Tracleer is the first orally-active treatment for PAH, which is thought to affect around 100,000 patients in the USA and Europe, to reach the market.
Tracleer is available in bottles of 60 tablets, in strengths of 62.5mg and 125mg, and the approved dose is 125mg twice-daily.
The product is distributed through a limited group of four specialty pharmacy operators, namely Caremark, Gentiva Health Services, Nova Factor and Procare Pharmacy, and can only be prescribed by physicians participating in the Tracleer Access Program, a measure designed to ensure use of the drug in appropriate patients. Around 11% of patients taking the endothelin antagonist exhibit reversible increases in liver enzymes, so recipients require monthly liver monitoring. Moreover, Tracleer can cause birth defects so should not be taken by women who are pregnant or may become pregnant, while monthly pregnancy tests are a condition of use for all other women of childbearing potential.
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