Full Prescribing Information
Please see full Prescribing Information for Ventavis® by clicking on the icon below.
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 predominantly 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 full Prescribing Information.