Recommended Dosing

VENTAVIS is intended to be inhaled using the I-neb® AAD® System. The recommended initial inhaled dose is 2.5 mcg (as delivered at the mouthpiece). If well tolerated, increase dosing to 5.0 mcg and maintain at that dose; otherwise maintain the dose at 2.5 mcg [see Warnings and Precautions (5.1)]. VENTAVIS should be taken 6 to 9 times per day (no more than once every 2 hours) during waking hours, according to individual need and tolerability. The maximum daily dose evaluated in clinical studies was 45 mcg (5 mcg 9 times per day).

Direct mixing of VENTAVIS with other medications in the I-neb® AAD® System has not been evaluated; do not mix with other medications. To avoid potential interruptions in drug delivery due to equipment malfunctions, the patient should have easy access to a back-up I-neb®AAD® System.

For each inhalation session, only a mouthpiece should be used. Avoid skin or eye contact with VENTAVIS solution. Do not orally ingest VENTAVIS solution.

VENTAVIS is supplied in 1 mL ampules in two concentrations: 10 mcg/mL and 20 mcg/mL.

The 20 mcg/mL concentration is intended for patients who are maintained at the 5 mcg dose and who have repeatedly experienced extended treatment times which could result in incomplete dosing. Transitioning patients to the 20 mcg/mL concentration using the I-neb® AAD® System will decrease treatment times to help maintain patient compliance.

For each inhalation session, the entire contents of each opened ampule of VENTAVIS should be transferred into the I-neb® AAD® System medication chamber immediately before use. Discard any solution remaining in the medication chamber after each inhalation session. Patients should follow the manufacturer's instructions for cleaning the I-neb® AAD® System components after each dose administration.