What is Ventavis?
Ventavis is a clear solution for inhalation use with a nebulizer. Ventavis contains the active ingredient iloprost.
What is Ventavis used for?
Ventavis is used for the treatment of adult patients with primary pulmonary hypertension of functional class III, with the aim of improving symptoms and the ability to exercise. Pulmonary hypertension is an abnormally high pressure in the pulmonary arteries. The term "primary" means that the heart or lungs are not affected by other diseases that cause high blood pressure, while the class reflects the severity of the disease: class III involves a significant limitation of physical activity. Considering the low number of patients suffering from primary pulmonary hypertension, this disease is rare and Ventavis has been called an "orphan medicine" (a medicine used to treat rare diseases) on 29 December 2000. The medicine can only be obtained with a prescription.
How is Ventavis used?
Ventavis is administered by inhalation using a nebulizer (a special device that turns the solution into an aerosol that is breathed by the patient). Treatment with Ventavis should be started and monitored by a doctor who has experience in the treatment of pulmonary hypertension. The recommended dose is 2.5 micrograms or 5.0 micrograms. The patient should start with the reduced dose of 2.5 micrograms for the first inhalation, followed by 5.0 micrograms for the second. The dose may then be reduced again to 2.5 micrograms if the patient is unable to tolerate the higher dose. The medicine is administered by a nebuliser called "dosimetric", which stops automatically after the pre-established dose has been delivered. The dose should be given six to nine times a day and the doses are lower if the patient has liver problems.
How does Ventavis work?
Pulmonary hypertension is a debilitating disease in which there is a strong constriction (narrowing) of the blood vessels of the lungs, which causes a very high pressure in the vessels that carry blood from the right side of the heart to the lungs. Ventavis is an inhalation formulation of iloprost, a substance very similar to prostacyclin, a naturally occurring molecule that causes dilation (expansion) of blood vessels. By dilating these blood vessels, the blood pressure is reduced and the symptoms improve.
What studies have been carried out on Ventavis?
Ventavis was compared with placebo (a dummy treatment) in a study involving 203 adult patients with stable pulmonary hypertension in class III or IV, both primary and induced by another disease. The main measure of effectiveness was the number of patients who responded to treatment after 12 weeks. By response we mean the combination of a 10% improvement in the ability to exercise (by measuring the distance the patient is able to walk while walking 6 minutes) and to improve the pathology (reduction of at least one class) without there being worsening pulmonary hypertension or death.
What benefit has Ventavis shown during the studies?
Ventavis demonstrated significant efficacy superior to placebo: 17% of patients taking Ventavis responded to therapy (17 of 101), compared with 5% of patients treated with placebo (5 out of 102). However, considering the different groups of patients in this study, the benefits of Vnetvis were only relevant for subjects with primary pulmonary hypertension of functional class III.
What is the risk associated with Ventavis?
The most common side effects (seen in more than one patient in 10) are vasodilation (the blood vessels dilate causing facial flushing), hypotension (low blood pressure) and cough. For the full list of all side effects reported with Ventavis, see the Package Leaflet. Ventavis should not be used in people who are hypersensitive (allergic) to iloprost or any of the other substances. Ventavis should not be used in patients at risk of bleeding, suffering from a heart problem, who have recently suffered a stroke or who suffer from pulmonary hypertension caused by occlusion or venous constriction. Furthermore, the medicindale should not be administered during pregnancy or breastfeeding.
Why has Ventavis been approved?
Despite the lack of available data, the Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of Ventavis outweigh the risks in the treatment of patients with primary pulmonary hypertension in NYHA functional class III, to improve symptoms and ability to exercise. The committee therefore recommended that Ventavis be given marketing authorization "in exceptional circumstances" because, since it is used to treat a rare disease, it was not possible to obtain more detailed information on the medicine. The European Medicines Agency (EMEA) reviews new available information every year and, where appropriate, updates this summary.
What information is still awaited for Ventavis?
The company that makes Ventavis will conduct other studies to gather information on the long-term use of the medicine.
More information on Ventavis
On 16 September 2003, the European Commission granted Ventavis a marketing authorization valid throughout the European Union to Bayer Schering Pharma AG. The marketing authorization was renewed on 16 September 2008.
Registration of the designation of Ventavis as an orphan medicinal product is available here.
For the full EPAR version of Ventavis, click here.
Last update of this summary: 09-2008
