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Emtricitabine/Tenofovir disoproxil Krka

Active Substance: emtricitabine / tenofovir disoproxil succinate
Common Name: emtricitabine / tenofovir disoproxil
ATC Code: J05AR03
Marketing Authorisation Holder: KRKA, d.d., Novo mesto
Active Substance: emtricitabine / tenofovir disoproxil succinate
Status: Authorised
Authorisation Date: 2016-12-09
Therapeutic Area: HIV Infections
Pharmacotherapeutic Group: Antivirals for systemic use

Therapeutic Indication

Treatment of HIV-1 infection

Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Emtricitabine/Tenofovir disoproxil Krka is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years (see section 5.1

Pre-exposure prophylaxis (PrEP)

Emtricitabine/Tenofovir disoproxil Krka is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

What is Emtricitabine/Tenofovir disoproxil Krka and what is it used for?

Emtricitabine/Tenofovir disoproxil Krka is an antiviral medicine that is 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). In addition, it may be used from the age of 12 years in adolescents with HIV that is resistant to first-line treatments or who cannot take them because of side effects.

Emtricitabine/Tenofovir disoproxil Krka is also used to help prevent sexually transmitted HIV-1 infection in adults who are at high risk of being infected (‘pre-exposure prophylaxis’). It should be used in combination with safer sex practices, such as 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 substances and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Truvada.

How is Emtricitabine/Tenofovir disoproxil Krka used?

Emtricitabine/Tenofovir disoproxil Krka can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.

Emtricitabine/Tenofovir disoproxil Krka is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil). The recommended dose for treating or preventing HIV-1 infection is one tablet once a day, preferably taken with food. If patients need to stop taking emtricitabine or tenofovir, or need 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, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug’ of tenofovir. This means that it is converted into tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor. Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself 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 hold off the damage to the immune system and the development of infections and diseases associated with AIDS.

For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Krka in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.

How has Emtricitabine/Tenofovir disoproxil Krka been studied?

Studies on the benefits and risks of the active substances in the approved uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Krka. As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Krka.

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.

What are the benefits and risks of 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 is Emtricitabine/Tenofovir disoproxil Krka approved?

The European Medicines Agency 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 Agency’s view was that, as for Truvada, the benefit outweighs the identified risk. The Agency 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 an information pack to doctors which covers the risk of reduced kidney function with Emtricitabine/Tenofovir disoproxil Krka, and information about use in adults for pre-exposure prophylaxis. Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving 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 Krka have also been included in the summary of product characteristics and the package leaflet.

Other information about Emtricitabine/Tenofovir disoproxil Krka

The European Commission granted a marketing authorisation valid throughout the European Union for Emtricitabine/Tenofovir disoproxil Krka on 9 December 2016.

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.