What it is:
Ventavis® is a solution of iloprost, a synthetic prostacyclin analogue, formulated to be inhaled with a special nebulizer programmed to ensure proper dosing. It has been approved for use in patients in functional class III or IV in the U.S., Europe and Australia.

FDA Approval:
The FDA approved Ventavis® for use in the U.S. in December of 2004. It had been used in parts of Europe and in Australia prior to this.

Distributed By:
Actelion Pharmaceuticals, US Inc., a subsidiary of Actelion Pharmaceuticals, a biopharmaceutical company headquartered in Allschwil/Basel, Switzerland. You may visit the Actelion website for more information.

About the drug and delivery systems:
Ventavis® (iloprost) Inhalation Solution is a clear, colorless, sterile solution containing 10 mcg/mL or 20 mcg/mL iloprost formulated for inhalation via either of two nebulizers. The two pulmonary drug delivery devices are the I-neb® AAD (Adaptive Aerosol Delivery) System and the Prodose® AAD® System. Each single-use glass ampule contains 1 mL of the solution to be added to the medication chamber of either pulmonary drug delivery device. Each mL of the 10mcg/mL 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. Each mL of the 20mcg/mL aqueous solution contains 0.02 mg iloprost, 1.62 mg ethanol, 0.242 mg tromethamine, 9.0 mg sodium chloride, and approximately 0.76 mg hydrochloric acid (for pH adjustment to 8.1) in water for injection. The solution contains no preservatives.

Nebulizers:

Dosing and routines:
Your doctor will determine the dose of Ventavis® you will receive. Your nebulizer will be programmed to deliver the appropriate dose for each session. Typically patients are asked to take from 10 to 20 minutes every two hours for a dosing session for a total of six sessions per day. You are not required to interrupt sleep during the night to take this drug.

In August 2009 the FDA approved Actelion's new 20 mcg/mL formulation of Ventavis. The new, increased strength formulation is said to deliver the same dose in half the volume, which is expected to reduce inhalation time and further support patient compliance.

Side Effects (data from drug trial results):
Side Effects may include one or more of the following: vasodilation (flushing, 27%), cough (39%), headache (30%), flu syndrome (14%), nausea (13%), trismus (12%), hypotension (11%), insomnia (8%), and syncope (8%); other serious adverse events reported with the use of Ventavis® included congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.

Special Monitoring:
Vital signs should be monitored while initiating Ventavis®. Dose adjustments or a change in therapy should be considered if exertional syncope occurs. Ventavis® should not be initiated in patients with systolic blood pressure lower than 85 mm Hg. Stop Ventavis® immediately if signs of pulmonary edema occur. This may be a sign of pulmonary venous hypertension. Ventavis® has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections.
 

For more complete information regarding Ventavis, you may visit the Ventavis website at http://www.4ventavis.com.

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For Additional Information Visit:

• Electronic Medicines Compendium (EMC): For patients in the U.K.
•  
• FDA Drug Search: For information about this drug and any other drug approved by the U.S. FDA – patient info sheets, label info, approval history etc.

September 2009 - Page reviewed and updated.