Intelence

etravirine

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This is a summary of the European public assessment report (EPAR) for Intelence. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Intelence.

For practical information about using Intelence, patients should read the package leaflet or contact their doctor or pharmacist.

What is Intelence and what is it used for?

Intelence is a medicine for treating human immunodeficiency virus type 1 (HIV‑1) in adults and children from 6 years of age. HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).

Intelence is only used in patients who have been treated for their HIV infection before and it must be used together with other HIV medicines that include a ‘boosted protease inhibitor’.

It contains the active substance etravirine.

How is Intelence used?

Intelence is available as tablets (25, 100 and 200 mg) to be swallowed whole with a glass of water. Patients who cannot swallow can disperse the tablets in a glass of water and then drink the solution immediately.

In adults, the recommended dose of Intelence is 200 mg twice a day after a meal while in children the dose depends on body weight and ranges from 100 mg twice a day to 200 mg twice a day.

This medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection. For further information, see the package leaflet.

How does Intelence work?

The active substance in Intelence, etravirine, is a non‑nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses. By blocking this enzyme, Intelence, taken in combination with other anti-HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level. Intelence does not cure HIV infection or AIDS, but it may delay damage to the immune system and the development of infections and diseases associated with AIDS.

What benefits of Intelence have been shown in studies?

Studies have shown that Intelence, in combination with other medicines, is effective at reducing the level of HIV in the blood (viral load) to undetectable levels (below 50 copies/ml) in many patients with HIV-1 infection.

In two main studies in a total of 1,203 adults, the average viral load was 70,000 copies/ml at the start of treatment. After 24 weeks, 59% of the patients taking Intelence together with other HIV medicines had undetectable levels of HIV, compared with 41% of those taking placebo (a dummy treatment) plus the other HIV medicines. These findings were maintained at 48 weeks.

In a main study of 101 children aged between 6 and 17 years, about half of them had undetectable levels of HIV after 24 weeks of taking Intelence in combination with other medicines, and the proportion of children with undetectable levels of HIV increased slightly after 48 weeks.

What are the risks associated with Intelence?

The most common side effect with Intelence (seen in more than 1 patient in 10) is rash.

Intelence should not be used together with elbasvir/grazoprevir, a medicine to treat hepatitis C infection. For the full list of all side effects and restrictions with Intelence, see the package leaflet.

Why is Intelence approved?

Intelence is effective at reducing viral load to undetectable levels in both adults and children and its side effects are considered manageable. The European Medicines Agency therefore concluded that its benefits outweigh its risks and recommended that it be approved in the EU.

What measures are being taken to ensure the safe and effective use of Intelence?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intelence have been included in the summary of product characteristics and the package leaflet.

Other information about Intelence

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Intelence on 28 August 2008. This was switched to a full marketing authorisation on 20 November 2013.

For more information about treatment with Intelence, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Intelence : EPAR - Summary for the public BG = bălgarski 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public ES = español 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public CS = čeština 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public DA = dansk 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public DE = Deutsch 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public ET = eesti keel 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public EL = elliniká 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public EN = English 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public FR = français 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public IT = italiano 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public LV = latviešu valoda 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public LT = lietuvių kalba 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public HU = magyar 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public MT = Malti 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public NL = Nederlands 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public PL = polski 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public PT = português 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public RO = română 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public SK = slovenčina 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public SL = slovenščina 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public FI = suomi 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public SV = svenska 2009-08-07 2017-10-27
Intelence : EPAR - Summary for the public HR = Hrvatski 2009-08-07 2017-10-27

This EPAR was last updated on 27/10/2017 .

Authorisation details

Product details

Product details for Intelence
NameIntelence
Agency product numberEMEA/H/C/000900
Active substance

etravirine

International non-proprietary name (INN) or common name

etravirine

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AG04

Publication details

Publication details for Intelence
Marketing-authorisation holder

Janssen-Cilag International NV

Revision22
Date of issue of marketing authorisation valid throughout the European Union28/08/2008

Contact address:

Janssen-Cilag International NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

Product information

13/07/2017  Intelence -EMEA/H/C/000900 -II/0050

Name Language First published Last updated
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18
Intelence : EPAR - Product Information HR = Hrvatski 2009-08-07 2017-08-18

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10
Intelence: EPAR - All Authorised presentations HR = Hrvatski 2008-09-04 2013-04-10

Pharmacotherapeutic group

Non-nucleoside reverse-transcriptase inhibitors

Therapeutic indication

Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.

This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Intelence: EPAR - Public assessment report HR = Hrvatski 2008-09-04  
Committee for medicinal products for human use, summary of positive opinion for Intelence HR = Hrvatski 2008-06-26