Emtricitabine/Tenofovir disoproxil Krka | European Medicines Agency (EMA)

[ad_1]

Overview

Emtricitabine/Tenofovir disoproxil Krka is an HIV medicine that is used in combination with at least one other HIV 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 in adolescents with HIV who are 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 and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP). 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 EU called Truvada.

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 about using Emtricitabine/Tenofovir disoproxil Krka, see the package leaflet or contact your doctor or pharmacist.

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.

For the treatment of HIV-1 infection, 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 holds 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.

Studies on the benefits and risks of the active substances in the authorised 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.

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.

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 of Emtricitabine/Tenofovir disoproxil Krka outweighs the identified risk and it can be authorised for use in the EU.

The company that markets Emtricitabine/Tenofovir disoproxil Krka will provide an information pack to doctors which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Krka on kidney function, and information about use 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.

As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Krka are continuously monitored. Side effects reported with Emtricitabine/Tenofovir disoproxil Krka are carefully evaluated and any necessary action taken to protect patients.

Emtricitabine/Tenofovir disoproxil Krka received a marketing authorisation valid throughout the EU on 9 December 2016.

English (EN)
(97.02 KB – PDF)

First published: 04/04/2017Last updated: 19/02/2019

View

English (EN)
(233.87 KB – PDF)

First published: 13/02/2020

View

Product information

English (EN)
(340.6 KB – PDF)

First published: 04/04/2017Last updated: 31/01/2025

View

Latest procedure affecting product information:
N/0000242560

31/01/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(33.78 KB – PDF)

First published: 04/04/2017Last updated: 29/10/2021

View

Product details

Name of medicine

Emtricitabine/Tenofovir disoproxil Krka

Active substance

emtricitabine
tenofovir disoproxil succinate

International non-proprietary name (INN) or common name

emtricitabine
tenofovir disoproxil

Therapeutic area (MeSH)

HIV Infections

Anatomical therapeutic chemical (ATC) code

J05AR03

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.

More information on Emtricitabine/Tenofovir disoproxil Krka

English (EN)
(66.45 KB – PDF)

First published: 09/07/2007Last updated: 07/12/2012

View

[ad_2]

Source link

Subscribe now

To access premium content

Ubisoft To Develop Blockchain Games, Enjin’s $100 Million Fund

All About Play to Earn With Crypto Games (P2E)

Blockchain Gaming Industry & 5 Crypto Games to Watch

Ethereum Still Leads The Way in Blockchain Gaming

What is Binamon? Ready For Launch On August 28

Binapet Review: Breeding BSC Play-to-Earn Game

The Galaxy of Lemuria Review – Play To Earn MMORPG

BLAST Premier 2022 – Betting Tips and Schedule

Zendodo Party Review: Where NFTs Meets DeFi on WAX

BLAST Premier 2022 – Betting Tips and Schedule

Is Overwatch League Getting Outsourced A Good Thing?

Genesis Worlds Interview With CEO Jason Cassidy

Dreamverse NFT Festival: Interview With Twobadour

Inside Axie Infinity With Jihoz – Growth Lead