Intelence

etravirine

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This is a summary of the European Public Assessment Report (EPAR) for Intelence. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Intelence.

What is Intelence?

Intelence is a medicine that contains the active substance etravirine. It is available as tablets (25, 100 and 200 mg).

What is Intelence used for?

Intelence is used to treat adults and children from six years of age who are infected with human immunodeficiency virus type 1 (HIV‑1), a virus that causes acquired immune deficiency syndrome (AIDS). Intelence is only used in patients who have been treated for their HIV infection before. Intelence must be used together with other anti-HIV medicines that include a ‘boosted protease inhibitor’.

The medicine can only be obtained with a prescription.

How is Intelence used?

Treatment with Intelence should be started by a doctor who has experience in the treatment of HIV infection.

In adults, the recommended dose of Intelence is 200 mg (as two 100-mg tablets or one 200-mg tablet) twice a day after a meal. In children, the dose depends on body weight and ranges from 100 mg twice a day to 200 mg twice a day. For patients who are unable to swallow the tablets, Intelence tablets can be dispersed by stirring them in a glass of water to form a milky solution. This solution has to be drunk immediately.

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 the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Intelence been studied?

Intelence has been studied in two main studies in adults, involving a total of 1,203 HIV-infected adults who had been taking anti‑HIV therapy that was not working any longer and who had few or no treatment options remaining. Both studies compared Intelence with placebo (a dummy treatment), when they were taken with boosted darunavir (a protease inhibitor) and at least two other anti-HIV medicines that were chosen for each patient as they had the best chances of reducing the levels of HIV in the blood. Intelence has also been studied in one main study involving 101 children aged between six and 17 years old who were infected with HIV and were already taking anti-HIV medicines. In this study, Intelence was not compared with another treatment and the children also took at least two other anti-HIV medicines. The main measure of effectiveness in all the studies was the number of patients with a level of HIV in the blood (viral load) that was below 50 copies/ml after 24 weeks of treatment.

What benefit has Intelence shown during the studies?

Intelence was more effective than placebo at reducing viral load in adults. Looking at the two studies in adults together, the average viral load was 70,000 copies/ml at the start of the studies. After 24 weeks, 59% of the patients taking Intelence (353 out of 599) had a viral load below 50 copies/ml, compared with 41% of those taking placebo (248 out of 604). These findings were maintained at 48 weeks. In children, 51.5% (52 out of 101) of the study participants had a viral load below 50 copies/ml after 24 weeks of taking Intelence, and this was slightly increased after 48 weeks.

What is the risk associated with Intelence?

The most common side effect with Intelence (seen in more than 1 patient in 10) is rash. For the full list of all side effects reported with Intelence, see the package leaflet.

Why has Intelence been approved?

The CHMP decided that Intelence’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Intelence was originally given ‘conditional approval’ because there was more evidence to come about the medicine, in particular regarding its use in combination with protease inhibitors other than darunavir. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.

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

A risk management plan has been developed to ensure that Intelence is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Intelence, including the appropriate precautions to be followed by healthcare professionals and patients.

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 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public ES = español 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public CS = čeština 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public DA = dansk 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public DE = Deutsch 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public ET = eesti keel 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public EL = elliniká 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public EN = English 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public FR = français 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public IT = italiano 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public LV = latviešu valoda 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public LT = lietuvių kalba 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public HU = magyar 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public MT = Malti 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public NL = Nederlands 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public PL = polski 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public PT = português 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public RO = română 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public SK = slovenčina 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public SL = slovenščina 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public FI = suomi 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public SV = svenska 07/08/2009 10/12/2013
Intelence : EPAR - Summary for the public HR = Hrvatski 07/08/2009 10/12/2013

This EPAR was last updated on 11/05/2016 .

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

Revision20
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

22/04/2016  Intelence -EMEA/H/C/000900 -N/0045

Name Language First published Last updated
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016
Intelence : EPAR - Product Information HR = Hrvatski 07/08/2009 11/05/2016

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 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013
Intelence: EPAR - All Authorised presentations HR = Hrvatski 04/09/2008 10/04/2013

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 04/09/2008  
Committee for medicinal products for human use, summary of positive opinion for Intelence HR = Hrvatski 26/06/2008