What is Emtricitabine / Tenofovir disoproxil Mylan and what is it used for?
Emtricitabine / Tenofovir disoproxil Mylan is an HIV medicine used in combination with at least one other medicine of the same type for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Emtricitabine / Tenofovir disoproxil Mylan is also used to prevent sexually transmitted HIV-1 infection in adults exposed to a high risk of contracting it (pre-exposure prophylaxis). It should be associated with safer sexual practices, such as condom use.
Emtricitabine / Tenofovir disoproxil Mylan contains two active substances: emtricitabine and tenofovir disoproxil. It is a "generic medicine". This means that it contains the same active substance and acts in the same way as a "reference medicine" already authorized in the European Union (EU) called Truvada. For more information on generic medicines, see the questions and answers by clicking here.
How is Emtricitabine / Tenofovir disoproxil Mylan used?
Emtricitabine / Tenofovir disoproxil Mylan can only be obtained with a prescription. Treatment should be started by a doctor with experience in the field of HIV infection.
Emtricitabine / Tenofovir disoproxil Mylan is available as tablets (200 mg of emtricitabine and 245 mg of tenofovir disoproxil). The recommended dose for treatment or prevention of HIV-1 infection is one tablet once a day, preferably taken with food. If patients need to stop taking emtricitabine or tenofovir or take different doses, they will need to use medicines containing emtricitabine or tenofovir disoproxil separately.
For more information, see the package leaflet
How does Emtricitabine / Tenofovir disoproxil Mylan work?
Emtricitabine / Tenofovir disoproxil Mylan contains two active ingredients: emtricitabine, a nucleoside reverse transcriptase inhibitor, and tenofovir disoproxil, a tenofovir "prodrug", which is transformed into tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor. Emtricitabine and tenofovir act in a similar way, blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to reproduce in the cells it has infected.
For the treatment of HIV infection, Emtricitabine / Tenofovir disoproxil Mylan, taken in combination with at least one other HIV medicine, reduces the amount of HIV present in the blood and keeps it at a low level. Emtricitabine / Tenofovir disoproxil Mylan does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
In the pre-exposure prophylaxis of HIV-1 infection, in the event of exposure to the virus the presence of Emtricitabine / Tenofovir disoproxil Mylan in the blood should block the proliferation and spread of the virus from the site of infection.
What benefit has Emtricitabine / Tenofovir disoproxil Mylan shown during the studies?
Studies on the benefits and risks of the active ingredients have already been carried out for the reference medicine, Truvada, and should not be repeated for Emtricitabine / Tenofovir disoproxil Mylan.
As with any medicine, the company has provided studies on the quality of Emtricitabine / Tenofovir disoproxil Mylan. In addition, he performed a study that showed his "bioequivalence" with 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 Emtricitabine / Tenofovir disoproxil 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 Emtricitabine / Tenofovir disoproxil Mylan?
Because Emtricitabine / Tenofovir disoproxil 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 Emtricitabine / Tenofovir disoproxil Mylan been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Emtricitabine / Tenofovir disoproxil Mylan has been shown to have comparable quality and to be bioequivalent to Truvada. Therefore, the CHMP considered that, as in the case of Truvada, the benefits outweigh the identified risks and recommended to approve the use of Emtricitabine / Tenofovir disoproxil Mylan in the EU.
What measures are being taken to ensure the safe and effective use of Emtricitabine / Tenofovir disoproxil Mylan?
The company that markets Emtricitabine / Tenofovir disoproxil Mylan will provide physicians with information on the risk of kidney disease related to Emtricitabine / Tenofovir disoproxil Mylan and use in pre-exposure prophylaxis. In addition, healthcare professionals will receive a brochure and a reminder sheet to distribute to those taking the medicine for pre-exposure prophylaxis.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtricitabine / Tenofovir disoproxil Mylan have also been included in the summary of product characteristics and the package leaflet.
Further information on Emtricitabine / Tenofovir disoproxil Mylan
On 16 December 2016, the European Commission granted a marketing authorization for Emtricitabine / Tenofovir disoproxil Mylan, valid throughout the European Union.
For the full EPAR version of Emtricitabine / Tenofovir disoproxil Mylan, see the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Emtricitabine / Tenofovir disoproxil 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.
Last update of this summary: 06-2017.
