Improved Exercise Capacity
Significantly improved exercise capacity as monotherapy
AIR Pivotal Trial: Randomized, double-blind, multicenter, placebo-controlled trial to evaluate the efficacy and safety of VENTAVIS® (iloprost) Inhalation Solution monotherapy compared with placebo in the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) NYHA Functional Class III or IV (n=146). Clinical improvement is a combined endpoint defined as ≥10% increase in 6MWD, improvement in NYHA Functional Class, and absence of clinical deterioration or death.1,4
- At Week 12, there was a 40-meter difference between VENTAVIS and placebo (change from baseline in 6-minute walk 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
INDICATION
VENTAVIS® (iloprost) Inhalation Solution 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
WARNINGS AND PRECAUTIONS
Risk of Syncope
- Vital signs should be monitored while initiating VENTAVIS. Hypotension leading to syncope has been observed; VENTAVIS should therefore not be initiated in patients with systolic blood pressure less than 85 mmHg.
Pulmonary Venous Hypertension
- Stop VENTAVIS immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension.
Bronchospasm
- VENTAVIS inhalation may cause bronchospasm and patients with a history of hyperreactive airway disease may be more sensitive.
ADVERSE REACTIONS
Serious Adverse Events
- Serious adverse events reported include congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.
Adverse Events
- Adverse events reported in a Phase 3 clinical trial occurring with a ≥3% difference between VENTAVIS patients and placebo patients were vasodilation (flushing) (27% vs 9%), increased cough (39% vs 26%), headache (30% vs 20%), trismus (12% vs 3%), insomnia (8% vs 2%), nausea (13% vs 8%), hypotension (11% vs 6%), vomiting (7% vs 2%), alkaline phosphatase increased (6% vs 1%), flu syndrome (14% vs 10%), back pain (7% vs 3%), tongue pain (4% vs 0%), palpitations (7% vs 4%), syncope (8% vs 5%), GGT increased (6% vs 3%), muscle cramps (6% vs 3%), hemoptysis (5% vs 2%), and pneumonia (4% vs 1%).
DRUG INTERACTIONS
Antihypertensives and Vasodilators
- VENTAVIS has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents.
Anticoagulants and Platelet Inhibitors
- VENTAVIS also has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants or platelet inhibitors.
SPECIFIC POPULATIONS
Lactation
- Advise not to breastfeed during treatment with VENTAVIS.
Please see full Prescribing Information.
cp-134777v3