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Emtricitabine/Tenofovir disoproxil Zentiva

Active Substance: emtricitabine, tenofovir disoproxil phosphate
Common Name: emtricitabine / tenofovir disoproxil
ATC Code: J05AR03
Marketing Authorisation Holder: Zentiva k.s.
Active Substance: emtricitabine, tenofovir disoproxil phosphate
Status: Authorised
Authorisation Date: 2016-11-09
Therapeutic Area: HIV Infections
Pharmacotherapeutic Group: Antivirals for systemic use

Therapeutic Indication

Emtricitabine/Tenofovir disoproxil Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).

Emtricitabine/Tenofovir disoproxil Zentiva 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).

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

Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva 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 Zentiva used?

Emtricitabine/Tenofovir disoproxil Zentiva can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.

Emtricitabine/Tenofovir disoproxil Zentiva is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil). The recommended dose is one tablet a day, 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 Zentiva work?

Emtricitabine/Tenofovir disoproxil Zentiva 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.

When taken in combination with at least one other antiviral medicine, Emtricitabine/Tenofovir disoproxil Zentiva reduces the amount of HIV in the blood and keeps it at a low level. Emtricitabine/Tenofovir disoproxil Zentiva does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.

How has Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva.

As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Zentiva. 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 Zentiva?

Because Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Emtricitabine/Tenofovir disoproxil Zentiva?

The company that markets Emtricitabine/Tenofovir disoproxil Zentiva will provide an information pack to doctors, which covers the risk of reduced kidney function with Emtricitabine/Tenofovir disoproxil Zentiva in adults and children.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtricitabine/Tenofovir disoproxil Zentiva have also been included in the summary of product characteristics and the package leaflet.

Other information about Emtricitabine/Tenofovir disoproxil Zentiva

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

For more information about treatment with Emtricitabine/Tenofovir disoproxil Zentiva, 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.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.