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.

December 29, 2004

Ventavis (iloprost) Inhalation Solution is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III or IV symptoms.

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:

Prodose AAD?System Weight: 3.19kg / 7.0lbs (including handpiece) Dimensions: 14 x 18 x 29 cm / 5.5” x 7” x 11.5” User Guide from Respironics

I-neb™ AAD® System Weight: 8 ounces (including battery) Dimensions: 1.7 x 2.55 x 5.90 inches User guide from Respironics

 

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.

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.

Clinical Studies Experience:
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.

Postapproval Experience:
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cases of bronchospasm and wheezing have been reported, particularly in patients with a history of hyperreactive airways. Cases of epistaxis and gingival bleeding have been reported within one month of starting Ventavis treatment. Cases of dizziness, diarrhea, mouth and tongue irritation, dysgeusia, hypersensitivity, and rash have also been reported with the use of Ventavis.

Because it is inhaled, Ventavis avoids the complications associated with parenteral prostacyclin therapy which may include serious bloodstream infections, pain associated with subcutaneous prostacyclin delivery, and the potential for pump and catheter-related complications associated with IV and subcutaneous prostacyclin therapies.

Prostacyclin (PGI₂) functions as a hormone, binding to receptors on smooth muscle cells, thereby affecting their function. Prostacyclin has multiple physiological effects, including vasodilation, inhibition of platelet aggregation, antiproliferation, anti-inflammation, and enhanced cardiac contractility.

The cost of iloprost is about $60,000 - $70,000 per year.

Actelion sponsors some financial assistance programs for eligible patients; others are available through alternative sources. PAH Pathways can help patients find and apply for the appropriate program or programs available to them.

Actelion Pharmaceuticals, US Inc

Electronic Medicines Compendium (EMC):  Information for patients in the U.K.

Full Prescribing Information