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Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily
Date:6/9/2009

ADCIRCA is a prescription medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature.

United Therapeutics Corporation licensed the rights to develop, market, promote and commercialize ADCIRCA for pulmonary hypertension in the United States and Puerto Rico from Eli Lilly & Company in November 2008. ADCIRCA contains the same active ingredient as CIALIS(R) (tadalafil), which is marketed by Eli Lilly & Company to treat erectile dysfunction (impotence) in more than 100 countries.

Important Safety Information for ADCIRCA

ADCIRCA should not be used in patients taking medicines that contain nitrates (often used for chest pain) as the combination could cause a sudden, unsafe drop in blood pressure. If a patient experiences anginal chest pain after taking ADCIRCA they should seek immediate medical attention. Patients with a known serious hypersensitivity to tadalafil (ADCIRCA or CIALIS) should not take ADCIRCA.

PDE5 inhibitors, including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be adversely affected by such effects. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD) and administration of ADCIRCA to these patients is not recommended. Patients should discuss their medical condition and all medications with their physician before starting ADCIRCA.

The use of ADCIRCA with alpha blockers, blood pressure medications, and alcohol may cause a lowering of blood pressure. Use of ADCIRCA with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided. For patients on ADCIRCA therapy that require treatment with ritonavir, dosage adjus
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SOURCE United Therapeutics Corporation
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