*Indication

Ventavis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominately patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue disease (23%).

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Improved Exercise Capacity

AIR Pivotal Trial: Randomized, double-blind, multicenter, placebo-controlled trial to evaluate the efficacy and safety of Ventavis Inhalation Solution compared to placebo in the treatment of pulmonary arterial hypertension (PAH*) seen at 30 min post-inhalation

• At week 12, there was a 40-meter difference between Ventavis and placebo (change from baseline in 6-minute distance measured 30 min post-inhalation; p <0.01)¹
• When measured immediately prior to inhalation, the improvement compared to placebo was approximately 60% of the effect seen at 30 min post-inhalation¹

IMPORTANT SAFETY INFORMATION

Hypotension leading to syncope has been observed; Ventavis should therefore not be initiated in patients with systolic blood pressure less than 85 mmHG. Stop Ventavis immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension. Ventavis inhalation may cause brochospasm and patients with a history of hyperreactive airway disease may be more sensitive. 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. In clinical studies, common adverse reactions due to Ventavis included vasodilation (flushing), cough, headache, trismus, and insomnia. Ventavis has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants.

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