Ambrisentan Mylan

Ambrisentan Mylan can only be obtained with a prescription and treatment must be started by a doctor who has experience in the treatment of PAH.

Ambrisentan Mylan is available as tablets (5 and 10 mg). Treatment is started at a dose of 5 mg daily and the doctor may increase it to 10 mg daily depending on response and any side effects experienced by the patient. The dose is increased to 10 mg daily when the medicine is used with tadalafil (another medicine for PAH). When taken with ciclosporin (a medicine that reduces the activity of the immune system) the dose of Ambrisentan Mylan should be 5 mg daily and the patient should be closely monitored by their doctor.

For more information about using Ambrisentan Mylan, see the package leaflet or contact your doctor or pharmacist.

PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs. It causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the flow of blood to the lungs. As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult. The active substance in Ambrisentan Mylan, ambrisentan, blocks the receptors (targets) for a hormone called endothelin, which causes blood vessels to become narrow. By blocking the effect of endothelin, Ambrisentan Mylan prevents the vessels becoming too narrow helping to lower the blood pressure and improving symptoms.

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Volibris, and do not need to be repeated for Ambrisentan Mylan.

As for every medicine, the company provided studies on the quality of Ambrisentan Mylan. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
 

Because Ambrisentan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Ambrisentan Mylan has been shown to have comparable quality and to be bioequivalent to Volibris. Therefore, the Agency’s view was that, as for Volibris, the benefit of Ambrisentan Mylan outweighs the identified risk and it can be authorised for use in the EU.

The company that markets Ambrisentan Mylan will provide a patient card containing important information on the medicine’s side effects and the need to avoid pregnancy during treatment.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ambrisentan Mylan have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Ambrisentan Mylan are continuously monitored. Side effects reported with Ambrisentan Mylan are carefully evaluated and any necessary action taken to protect patients.