Generic name: iloprost 0.01mg in 1mL
Dosage form: inhalation solution
Medically reviewed on October 23, 2017.
Ventavis is intended to be inhaled using the I-neb® AAD® System. The first inhaled dose should be 2.5 mcg (as delivered at the mouthpiece). If this dose is well tolerated, dosing should be increased to 5.0 mcg and maintained at that dose; otherwise maintain the dose at 2.5 mcg. 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.
Ventavis is supplied in 1 mL ampules in two concentrations: 10 mcg/mL and 20 mcg/mL.
|Delivered dose from ampule of :|
|Nebulizer||10 mcg/mL||20 mcg/mL|
|I-neb® AAD®||2.5 or 5 mcg from one ampule||5 mcg from one ampule|
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 [see Patient Counseling Information (17.1)]. After each inhalation session, any solution remaining in the medication chamber should be discarded. Use of the remaining solution will result in unpredictable dosing. Patients should follow the manufacturer's instructions for cleaning the I-neb® AAD® System components after each dose administration.
Vital signs should be monitored while initiating Ventavis. [see Warnings and Precautions (5.1)].
Use in Patients with Pre-existing Hepatic Impairment
Because iloprost elimination is reduced in patients with impaired liver function [see Use in Specific Populations (8.6)], consider increasing the dosing interval (e.g., 3-4 hours between doses depending on the patient's response at the end of the dose interval) in patients with Child-Pugh Class B or C hepatic impairment.
Use in Patients with Pre-existing Renal Impairment
Dose adjustment is not required in patients who are not on dialysis. The effect of dialysis on iloprost is unknown [see Use in Specific Populations (8.7)].
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- Drug class: agents for pulmonary hypertension