*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%).

• About Ventavis

•      Indications

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•      Efficacy

•           Improved Exercise
            Capacity

•           Functional Class
            Improvement

•           Improved
            Hemodynamics

•      Safety Profile

•      Dosage & Administration

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Clinical Improvement

Ventavis^® (iloprost) Inhalation Solution is the first PAH* therapy in which clinical improvement was the primary endpoint of study design. In a placebo-controlled, randomized, double-blind, multicenter study, patients in the Ventavis group saw a nearly 5-fold improvement in clinical endpoint versus patients in the placebo.¹

Primary endpoint of study

The primary endpoint was a combined measure of 3 factors¹:

1. Lack of clinical deterioration or death
2. Improved walking distance on the 6-minute walk test by at least 10%
3. Improvement in one (1) NYHA functional class

Significant improvement in combined clinical endpoint¹

AIR Pivotal Trial Randomized, double-blind, multicenter, placebo-controlled trial to evaluate the efficacy and safety of Ventavis in the treatment of PAH* NYHA Class III or IV (n=146).
^‡ Combined clinical endpoint defined as a) at least 10% increase vs. baseline in 6-minute walk distance with b) improvement by at least one NYHA Class vs. baseline without c) death or clinical worsening
^§ WHO Group I includes idiopathic PAH*, familial PAH*, PAH* associated with related condition (e.g., collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, HIV infection, drugs and toxins, etc.)
^|| Change from baseline to 12 weeks with measurement 30 minutes after dosing.

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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