Author: Bayer Schering Pharma AG


Long information

What is it?

Ventavis is a solution for inhalation using a nebuliser. It contains the active substance iloprost.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Ventavis is used for the treatment of patients with class III primary pulmonary hypertension to improve exercise capacity (the ability to carry out physical activity) and symptoms. Pulmonary hypertension is abnormally high blood pressure in the arteries of the lungs. ?Primary? means that there are no other diseases of the heart or lungs causing the high blood pressure, and the ?class? reflects the severity of the symptoms caused by the disease: ?class III? involves marked limitation of physical activity.

Because the number of patients with primary pulmonary hypertension is low, the disease is considered ?rare?, and Ventavis was designated an ?orphan medicine? (a medicine used in rare diseases) on 29 December 2000.

The medicine can only be obtained with a prescription.

How is it used?

Treatment with Ventavis should be started and monitored by a doctor experienced in the treatment of pulmonary hypertension. Ventavis is given by inhalation using a nebuliser (a special machine that changes the solution into an aerosol that the patient can breathe in).

The recommended dose is 2.5 or 5.0 micrograms. Patients should start with the low dose of 2.5 micrograms for the first inhalation, followed by 5.0 micrograms for the second. The dose can then be reduced to 2.5 micrograms again if the patient cannot tolerate the higher dose. The medicine must be given using a type of nebuliser known as a ?dosimetric? nebuliser, which stops automatically when the correct dose has been delivered. It is given six to nine times a day. If the patient has liver or kidney problems, the time between doses should be at least 3 hours.

How does it work?

Pulmonary hypertension is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs that causes high blood pressure in the vessels taking blood from the right side of the heart to the lungs. Ventavis is an inhaled formulation of iloprost, a substance that is very similar to prostacyclin, a naturally occurring molecule that causes blood vessels to dilate (expand). By dilating these blood vessels, the blood pressure is reduced and symptoms are improved.

How has it been studied?

Ventavis has been compared with placebo (a dummy treatment) in one study involving 203 adults with stable class III or IV pulmonary hypertension that was either primary or caused by another condition. The main measure of effectiveness was the number of patients who had responded to treatment after 12 weeks. A ?response? was defined as a combination of a 10% improvement in exercise capacity (measured by looking at how far the patient could walk in six minutes) and an improvement of the patient?s condition (the severity of the disease going down by at least one class), without a worsening of pulmonary hypertension or death.

What benefits has it shown during the studies?

Ventavis was significantly more effective than placebo: 17% of the patients taking Ventavis responded to treatment (17 out of 101), compared with 5% of the patients taking placebo (5 out of 102). However, when looking at different groups of patients in this study, a benefit of Ventavis that would be relevant for patients was only shown in patients with class III primary pulmonary hypertension.

What is the risk associated?

The most common side effects with Ventavis (seen in more than 1 patient in 10) are headache, vasodilation (blood vessels becoming wider causing flushing or reddening of the face), bleeding, chest pain and discomfort, nausea (feeling sick), pain in the jaw and contraction of the jaw muscles, and increase in coughing. For the full list of all side effects reported with Ventavis, see the package leaflet.

Ventavis should not be used in people who may be hypersensitive (allergic) to iloprost or any of the other ingredients. It must not be used in patients who are at risk of bleeding, who have certain heart problems, who have recently had a stroke, or whose pulmonary hypertension is caused by a blocked or narrow vein. It must also not be used in women who are pregnant or breast-feeding.

Why has it been approved?

The CHMP decided that, despite the limited data available, Ventavis?s benefits are greater than its risks and recommended that it be given marketing authorisation.

Ventavis has been authorised under ?exceptional circumstances?, because, as the disease is rare, it has not been possible to obtain complete information on the medicine. Every year, the European Medicines

Agency will review any new information that may become available and this summary will be updated as necessary.

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