VENTAVIS SUMMARY
Ventavis®
(iloprost) Inhalation Solution
Rx Only
Ventavis (iloprost) Inhalation Solution is a clear, colorless, sterile solution containing 10 mcg/mL iloprost formulated for inhalation via either of two pulmonary drug delivery devices: the I-neb™ AAD® (Adaptive Aerosol Delivery) System or the Prodose® AAD® System. Ventavis is supplied in 2 ampule configurations, a 2 mL and a 1 mL single-use glass ampule. Both ampule sizes contain 10 mcg/1 mL. Each mL of the aqueous solution contains 0.01 mg iloprost, 0.81 mg ethanol, 0.121 mg tromethamine, 9.0 mg sodium chloride, and approximately 0.51 mg hydrochloric acid (for pH adjustment to 8.1) in water for injection. The solution contains no preservatives.
Ventavis is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III or IV symptoms. In controlled trials, it improved a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration (see CLINICAL PHARMACOLOGY, Clinical Trials).
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