What is Darunavir Mylan used for and what is it used for?
Darunavir Mylan is an antiviral medicine used in combination with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is given in combination with low doses of ritonavir or, in adults, with cobicistat. Darunavir Mylan can be given to adults or children from the age of three years up to 15 kg.
Darunavir Mylan contains the active substance darunavir.
Darunavir Mylan is a "generic medicine". This means that Darunavir Mylan contains the same active substance and acts in the same way as a 'reference medicine' already authorized in the European Union (EU) called Prezista. For more information on generic medicines, see the questions and answers by clicking here.
How is Darunavir Mylan used?
Darunavir Mylan can only be obtained with a prescription. Treatment should be started by a healthcare professional with experience in managing HIV infection.
Darunavir Mylan is available as tablets (75, 150, 300, 400, 600 and 800 mg). The medicine is always given in combination with cobicistat (in adults) or ritonavir at low doses (in adults and children) plus other HIV medicines and should be taken with food.
For adults not previously treated, the recommended dose is 800 mg once a day. For previously treated adults, the dose is 600 mg twice a day. Previously treated patients may also take a dose of 800 mg once a day, provided that HIV infection is adequately controlled and no resistance to darunavir is expected.
For children and teenagers from three to 17 years of age and weighing not less than 15 kg not previously treated, the recommended dose ranges from 600 to 800 mg once a day, based on weight. For children and young people treated previously the usual recommended dose is 375 to 600 mg twice a day, depending on weight.
For more information, see the package leaflet.
How does Darunavir Mylan work?
The active substance in Darunavir Mylan, darunavir, is a protease inhibitor, which means that it blocks an enzyme called protease, which contributes to the reproduction of HIV. Once the enzyme is blocked, the virus ceases to reproduce normally, so that its proliferation in the body slows down. Darunavir Mylan is always given in combination with ritonavir or cobicistat, the action of which slows down the assimilation of darunavir, thereby increasing blood levels. This action allows an effective treatment while avoiding the administration of higher doses of darunavir.
Taken in combination with other HIV medicines, Darunavir Mylan reduces the amount of these viruses in the blood and keeps it at a low level. Darunavir Mylan does not cure HIV infection or AIDS, but as an HIV treatment it can delay the damage to the immune system and the development of infections and diseases associated with AIDS.
What benefit has Darunavir Mylan shown during the studies?
With the reference medicine (Prezista), studies have already been carried out on the benefits and risks of the active ingredient for the approved use, which therefore should not be repeated for Darunavir Mylan. As with any medicine, the company has made available studies on the quality of Darunavir Mylan.
In addition, he performed studies that showed that Darunavir Mylan is "bioequivalent" to the reference medicine. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body, so they are expected to have the same effect.
Because Darunavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
What are the risks associated with Darunavir Mylan?
Because Darunavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Darunavir Mylan been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Darunavir Mylan has been shown to have comparable quality and to be bioequivalent to Prezista. Therefore, the CHMP considered that, as in the case of Prezista, the benefits outweigh the identified risks and recommended to approve the use of Darunavir Mylan in the EU.
What measures are being taken to ensure the safe and effective use of Darunavir Mylan?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Mylan have been included in the summary of product characteristics and the package leaflet.
More information on Darunavir Mylan
For the full EPAR of Darunavir Mylan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Darunavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can also be found on the Agency's website.
