What is Emtricitabine - Tenofovir disoproxil Krka and what is it used for?
Emtricitabine / tenofovir disoproxil Krka is an antiviral medicine used in combination with at least one other antiviral medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome ( AIDS).
Emtricitabine / tenofovir disoproxil Krka is also used to prevent sexually transmitted HIV-1 infection in adults at high risk for such an infection (pre-exposure prophylaxis). It should be used in combination with safer sexual practices, such as condom use.
Emtricitabine / tenofovir disoproxil Krka 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 Krka used?
Emtricitabine / tenofovir disoproxil Krka can only be obtained with a prescription. Treatment should be started by a doctor who has experience in managing HIV infection.
Emtricitabine / tenofovir disoproxil Krka is available as tablets (200 mg of emtricitabine and 245 mg of tenofovir disoproxil). The recommended dose for treatment or prevention of HIV infection is one tablet once a day, preferably taken with food. If patients have to stop taking emtricitabine or tenofovir or have to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.
For more information, see the package leaflet.
How does Emtricitabine - Tenofovir disoproxil Krka work?
Emtricitabine / tenofovir disoproxil Krka contains two active substances: emtricitabine, a nucleoside reverse transcriptase inhibitor, and tenofovir disoproxil, a tenofovir "prodrug", in the sense that it converts to tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor. Emtricitabine and tenofovir act similarly by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to reproduce in the cells it has infected.
Emtricitabine / tenofovir disoproxil Krka, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level. Emtricitabine / tenofovir disoproxil Krka 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 infection, it is expected that, in the event of exposure to the virus, the presence of Emtricitabine / tenofovir disoproxil Krka in the blood will block its proliferation and spread from the site of infection.
What benefit has Emtricitabine - Tenofovir disoproxil Krka shown during the studies?
Studies on the benefits and risks of the active substance for approved uses have already been carried out for the reference medicine, Truvada, and should not be repeated for Emtricitabine / tenofovir disoproxil Krka.
As with any medicine, the company has provided studies on the quality of Emtricitabine / tenofovir disoproxil Krka. In addition, it performed a study that showed its "bioequivalence" compared 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 Emtricitabine / tenofovir disoproxil Krka 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 Krka?
Because Emtricitabine / tenofovir disoproxil Krka 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 Krka been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Emtricitabine / tenofovir disoproxil Krka 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 Krka in the EU.
What measures are being taken to ensure the safe and effective use of Emtricitabine - Tenofovir disoproxil Krka?
The company that markets Emtricitabine / tenofovir disoproxil Krka will provide doctors with an information pack that illustrates the risk of kidney disease related to Emtricitabine / tenofovir disoproxil Krka in pre-exposure prophylaxis. In addition, healthcare professionals will receive a leaflet and reminder card to distribute to those taking Emtricitabine / tenofovir disoproxil Krka 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 Krka have also been included in the summary of product characteristics and the package leaflet.
More information on Emtricitabine - Tenofovir disoproxil Krka
On 9 December 2016, the European Commission granted a marketing authorization for Emtricitabine / tenofovir disoproxil Krka, valid throughout the European Union.
For the full EPAR version of Emtricitabine / tenofovir disoproxil Krka, 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 Krka, 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: 04-2017.
