In the U.S., iloprost is inhaled specifically using the I-Neb AAD or Prodose AAD delivery systems. In Europe iloprost has been approved for use with two compressed air nebulizers with AAD delivery systems as well as with two ultrasonic nebulizers Ventaneb and I-Neb. Ventavis is supplied in 1 mL single-use glass ampules containing either 10 μg/mL or 20 μg/mL. The 20 μg/mL concentration is intended for patients who are maintained at the 5 μg dose and who have repeatedly experienced extended treatment times which could result in incomplete dosing. Transitioning patients to the 20 μg/mL concentration using the I-neb AAD System will decrease treatment times to help maintain patient compliance. The approved dosing regimen for iloprost is 6 to 9 times daily during waking hours, according to individual need and tolerability. The significant clinical effects observed in the pivotal study of patients with PAH were achieved with a median dose of 30 μg per day, corresponding to 6 daily inhalations of 5 μg. The majority of patients in the pivotal study used this median dose or a higher dose with an excellent treatment compliance after 12 weeks. The first inhaled dose of iloprost should be 2.5 μg. If this dose is well tolerated, dosing should be increased to 5 μg and maintained at that dose. Any patient who cannot tolerate the 5 μg dose should be maintained at 2.5 μg. Each inhalation treatment requires one entire single-use ampule. Each single-use ampule delivers a concentration of 10 μg/mL to the medication chamber of either the I-Neb AAD or Prodose AAD System, and delivers a nominal dose of either 2.5 μg or 5.0 μg to the mouthpiece. After each inhalation session, any solution remaining in the medication chamber should be discarded. Use of the remaining solution, even if the reservoir is "topped off" with fresh medication, will result in unpredictable dosing. Patients should follow the manufacturer's instructions for cleaning the I-Neb AAD or Prodose AAD System components after each dose administration. Complete information regarding use of iloprost in specific populations, drug interactions, and overdosage can be found in full prescribing information.
Intravenous iloprost
Iloprost is also available in an intravenous form, developed and marketed by Schering AG under the trade name Ilomedine. IV iloprost is usually administered diluted, via a peripheral vein or central venous catheter. The diluted iloprost should be delivered by an accurate rate delivery system such as a syringe driver. Doses vary with individuals as side effects are better tolerated by some patients than others. The duration of the treatment is typically 3 days. This is usually repeated every 8 to 12 weeks
Important safety information
Contraindications:
unstable angina; within 6 months of myocardial infarction; decompensated cardiac failure ; severe arrhythmias; congenital or acquired heart-valve defects; within 3 months of cerebrovascular events; pulmonary veno-occlusive disease; conditions which increase risk of bleeding.
Serious adverse events reported with the use of inhaled iloprost include congestive heart failure, chest pain, supraventricular tachycardia, shortness of breath, peripheral edema, and kidney failure. Warnings:
Iloprost as Ventavis is intended for inhalation administration only via the I-Neb AAD or Prodose AAD Systems, pulmonary drug delivery devices. It has not been studied with any other nebulizers.
Vital signs should be monitored while initiating inhaled iloprost therapy. Dose adjustments or a change in therapy should be considered if exertional syncope occurs. Inhaled iloprost should not be initiated in patients with systolic blood pressure lower than 85 mm Hg. Iloprost should be stopped immediately if signs of pulmonary edema occur. This may be a sign of pulmonary venous hypertension. Iloprost has not been evaluated in patients with chronic obstructive pulmonary disease, severe asthma, or with acute pulmonary infections.
Should signs of pulmonary edema occur when inhaled iloprost is administered in patients with pulmonary hypertension, the treatment should be stopped immediately. This may be a sign of pulmonary venous hypertension.
