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Ventavis (Iloprost Inhalation) - Summary

 
 



VENTAVIS SUMMARY

Ventavis (iloprost) Inhalation Solution is a clear, colorless, sterile solution containing 10 mcg/mL iloprost formulated for inhalation via either of two pulmonary drug delivery devices: the I-neb™ AAD® (Adaptive Aerosol Delivery) System or the Prodose® AAD® System. Ventavis is supplied in 2 ampule configurations, a 2 mL and a 1 mL single-use glass ampule. Both ampule sizes contain 10 mcg/1 mL. 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 hydrochloric acid (for pH adjustment to 8.1) in water for injection. The solution contains no preservatives.

Ventavis is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III or IV symptoms. In controlled trials, it improved a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration (see CLINICAL PHARMACOLOGY, Clinical Trials).


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NEWS HIGHLIGHTS

Published Studies Related to Ventavis (Iloprost Inhalation)

Comparison of inhaled nitric oxide with aerosolized iloprost for treatment of pulmonary hypertension in children after cardiopulmonary bypass surgery. [2011.07]
OBJECTIVES: Pilot study to compare the effect of inhaled nitric oxide (iNO) and aerosolized iloprost in preventing perioperative pulmonary hypertensive crises (PHTCs). BACKGROUND: Guidelines recommend the use of iNO to treat PHTCs, but treatment with iNO is not an ideal vasodilator. Aerosolized iloprost may be a possible alternative to iNO in this setting... CONCLUSIONS: In this pilot study, aerosolized iloprost had a favorable safety profile. Larger trials are needed to compare its efficacy to iNO for the treatment of perioperative pulmonary hypertension. However, neither treatment alone abolished the occurrence of PHTCs.

Oral iloprost improves endobronchial dysplasia in former smokers. [2011.06]
There are no established chemopreventive agents for lung cancer, the leading cause of cancer death in the United States. Prostacyclin levels are low in lung cancer and supplementation prevents lung cancer in preclinical models...

Oral iloprost improves endobronchial dysplasia in former smokers. [2011]
There are no established chemopreventive agents for lung cancer, the leading cause of cancer death in the United States. Prostacyclin levels are low in lung cancer and supplementation prevents lung cancer in preclinical models...

Long-term therapy with inhaled iloprost in patients with pulmonary hypertension. [2010.05]
CONCLUSION: Inhaled iloprost is well tolerated as long-term therapy and no substantial dose increase is required. Although uncontrolled, the data suggest a long-term clinical benefit from continued therapy with inhaled iloprost.

Acute and long-term effects of inhaled iloprost in portopulmonary hypertension. [2010.03]
Portopulmonary hypertension (PoPH) is a serious condition without an established treatment.A randomized, controlled trial is warranted to establish its clinical role in this serious condition.

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Clinical Trials Related to Ventavis (Iloprost Inhalation)

The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting [Terminated]
A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"

Ventavis´┐Ż Registry Protocol [Terminated]
The Ventavis« (iloprost) Registry is a multicenter, observational, U. S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis« for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis« will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis« adherence data.

Iloprost Power Disc-15 in Pulmonary Arterial Hypertension [Terminated]
A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb« Adaptive Aerosol Delivery« System (I-neb« AAD«)

Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension [Completed]
Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or currently being treated with a stable dose of either bosentan or sildenafil and who complete PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12 week), randomized study to compare the safety and tolerability of inhaled iloprost power disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (PAH). After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.

Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease [Completed]
The objective of this study was to assess the efficacy and appropriate dose of iloprost for inhalation in the treatment of postoperative pulmonary hypertension in children with congenital heart defects.

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Reports of Suspected Ventavis (Iloprost Inhalation) Side Effects

Death (285)Dyspnoea (181)Dizziness (79)Pulmonary Arterial Hypertension (72)Oedema Peripheral (68)Pneumonia (60)Headache (59)Cough (57)Nausea (50)Condition Aggravated (50)more >>


Page last updated: 2013-02-10

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