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What it is:
Ventavis® is a solution of Iloprost formulated to be inhaled with a special nebulizer programmed to ensure proper dosing. It has been approved for use for patients in functional class III or IV in the U.S., Europe and Australia.
FDA Approval:
Ventavis® was approved by the FDA for use in the U.S. in December of 2004. It had been used in parts of Europe and in Australia prior to this.
Produced By:
CoTherix, a pharmaceutical company headquartered in the San Francisco Bay Area, produces this drug for the U.S. market.. You may visit CoTherix website for more information.
About the drug and delivery systems:
Ventavis® (Iloprost) Inhalation Solution is a clear, colorless, sterile solution containing 10 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 2 mL (20 meg) of the solution to be added to the medication chamber of either pulmonary drug delivery device. Each mL of the 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 hdrochloric 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 seession. 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.
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.
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