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%).
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 bronchospasm 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, the most common adverse events occurring more often (≥6%) in Ventavis-treated patients than in patients taking placebo included vasodilation (flushing) (27% vs 9%), cough (39% vs 26%), headache (30% vs 20%), trismus (12% vs 3%), and insomnia (8% vs 2%). Ventavis has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents. Ventavis also has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants.
Please see accompanying full Prescribing Information.