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

•      Efficacy

•           Clinical Improvement

•           Improved Exercise
            Capacity

•           Functional Class
            Improvement

•           Improved
            Hemodynamics

•      Safety Profile

•      Dosage & Administration

•      FAQs

•      Ventavis Support

• About the I-neb AAD
  System

• Services for Your Patients

• Resources

• Prescribing Information

• For Patients and
  Caregivers

Clinical Trials

The combined primary endpoint was clinical response at 12 weeks, defined as:

1. At least 10% increase vs. baseline in 6-minute walk distance¹
2. Improvement by at least one NYHA Class vs. baseline^1,2
3. Lack of clinical deterioration or death

Studied as combination therapy

• In a small study, 34 patients treated with bosentan 125 mg bid for at least 16 weeks tolerated the addition of inhaled iloprost (up to 5 mcg 6 to 9 times per day during waking hours). The mean daily inhaled dose was 27 mcg and the mean number of inhalations per day was 5.6.²
• Safety trends in patients receiving concomitant bosentan and iloprost were consistent with those observed in the larger Phase 3 study (AIR) in patients receiving only iloprost.²

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.

Please see full Prescribing Information