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 immunodeficiency syndrome ( AIDS).
Emtricitabine / Tenofovir disoproxil Krka is also used to prevent sexually transmitted HIV-1 infection in adults at high risk of getting this infection (pre-exposure prophylaxis). It should be used in conjunction with safer sexual practices such as sexually transmitted HIV-1 infection. use of condoms.
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 works 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 used - Tenofovir disoproxil Krka?
Emtricitabine / Tenofovir disoproxil Krka can only be obtained with a prescription. Treatment should be started by a doctor with experience in the management of HIV infection.
Emtricitabine / Tenofovir disoproxil Krka is available as tablets (200 mg of emtricitabine and 245 mg of tenofovir disoproxil). The recommended dose for the 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 dosages, 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 'prodrug' of tenofovir, meaning that it converts to tenofovir in the body. Tenofovir is a nucleoside reverse transcriptase inhibitor. Emtricitabine and tenofovir work 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 can delay damage to the immune system and the development of AIDS-associated infections and diseases.
In pre-exposure prophylaxis of HIV infection, the presence of Emtricitabine / tenofovir disoproxil Krka in the blood is expected to block its proliferation and spread from the site of infection in the event of exposure to the virus.
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 performed for the reference medicine, Truvada, and should not be repeated for Emtricitabine / Tenofovir disoproxil Krka.
As with any medicine, the company provided quality studies for Emtricitabine / tenofovir disoproxil Krka. It also carried out a study which showed that it was 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance 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 taken as being the same as the reference medicine's.
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 taken as being the same as the reference medicine's.
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 that Emtricitabine / Tenofovir disoproxil Krka be approved for use 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 explaining the risk of kidney disease linked to Emtricitabine / tenofovir disoproxil Krka in pre-exposure prophylaxis. Additionally, healthcare professionals will receive a leaflet and reminder card to be distributed to those taking Emtricitabine / Tenofovir disoproxil Krka for pre-exposure prophylaxis.
The recommendations and precautions to be observed by healthcare professionals and patients for Emtricitabine / Tenofovir disoproxil Krka to be used safely and effectively have also been reported in the summary of product characteristics and package leaflet.
More information about Emtricitabine - Tenofovir disoproxil Krka
On 9 December 2016, the European Commission issued 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 Emtricitabine / Tenofovir disoproxil Krka therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 04-2017.
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