Celsentri

maraviroc

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About

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Celsentri?

Celsentri is a medicine that contains the active substance maraviroc. It is available as blue, oval tablets (150 or 300 mg).

What is Celsentri used for?

Celsentri is used to treat adults who are infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).

Celsentri is used in combination with other anti-HIV medicines, and only in patients who have been treated for HIV infection before and only when the HIV 1 they are infected with is ‘CCR5-tropic’, which is determined by a blood test. This means that the virus, when infecting a cell, attaches to a specific protein called CCR5 on the surface of the cell.

The medicine can only be obtained with a prescription.

How is Celsentri used?

Treatment with Celsentri should be started by a doctor who has experience in the management of HIV infection. Before treatment, the doctor must check that the patient’s blood only shows infection with CCR5-tropic virus, using a newly drawn blood sample and a reliable ‘tropism test’.

The recommended dose is 150, 300 or 600 mg twice a day, depending on the other medicines that the patient is taking. Patients who have kidney problems may need to take Celsentri less frequently if they are taking other medicines that are broken down in the body (metabolised) in the same way as Celsentri, and their response to treatment should be closely monitored. For more information, see the summary of product characteristics (also part of the EPAR).

There is no information on switching to Celsentri from another type of medicine for HIV infection in patients whose HIV is being treated successfully, when no virus can be detected in their blood. There is also no information on the re-use of Celsentri in patients who have taken it in the past, but in whom it stopped working. Other treatments should be considered in these cases.

How does Celsentri work?

The active substance in Celsentri, maraviroc, is a ‘CCR5 antagonist’. It blocks a protein called CCR5, which is found on the surface of the cells in the body that HIV infects. The CCR5-tropic HIV uses this protein to enter the cells. By attaching itself to the protein, maraviroc prevents it from entering the cells. Maraviroc cannot work when the virus that the patient is infected with attaches to another protein called CXCR4 to enter the cells, or when it can attach to both CCR5 and CXCR4. As HIV can only reproduce itself within cells, Celsentri, taken in combination with other anti-HIV medicines, reduces the level of CCR5-tropic HIV in the blood of patients, and keeps it at a low level.

Celsentri 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 Celsentri been studied?

Celsentri, taken once or twice a day, has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,076 patients with CCR5-tropic HIV infection. The patients had previously taken other treatments for HIV for at least six months, but these had stopped working. The effects of Celsentri, taken once or twice a day, were compared with those of placebo (a dummy treatment). All of the patients also took ‘optimised background therapy’ (a combination of other anti-HIV medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood). The main measure of effectiveness was the reduction in the levels of HIV in the blood (viral load) after 24 weeks.

What benefit has Celsentri shown during the studies?

Celsentri was more effective than placebo in reducing viral loads, when taken in combination with optimised background therapy. Looking at the results of the two studies taken together, viral loads had fallen by an average of 99% after 24 weeks in the patients adding Celsentri to optimised background therapy, compared with 90% in those adding placebo. The proportion of patients who had undetectable levels of HIV in their blood was about 45% when Celsentri was added to optimised background therapy compared with 23% of the patients receiving optimised background therapy only. Similar results were also seen when looking at the patients who continued treatment with Celsentri 300 mg twice a day for 48 weeks.

The effects of once- and twice-daily doses of Celsentri were similar. However, the twice-daily dose was slightly more effective in patients who were at risk of a reduced response to HIV treatment, due to high viral load, low levels of immunity or few available treatment options.

What is the risk associated with Celsentri?

The most common side effects with Celsentri (seen in between one and 10 patient in 100) are nausea (feeling sick), diarrhoea, fatigue (tiredness) and headache. For the full list of all side effects reported with Celsentri, see the package leaflet.

Celsentri should not be used in patients who may be hypersensitive (allergic) to maraviroc, peanut, soya or any of the other ingredients.

Why has Celsentri been approved?

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

Other information about Celsentri

The European Commission granted a marketing authorisation valid throughout the European Union for Celsentri on 18 September 2007. The marketing-authorisation holder is ViiV Healthcare UK Ltd. The marketing authorisation is valid for five years, after which it can be renewed.

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

Name Language First published Last updated
Celsentri : EPAR - Summary for the public BG = bălgarski 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public ES = español 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public CS = čeština 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public DA = dansk 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public DE = Deutsch 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public ET = eesti keel 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public EL = elliniká 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public EN = English 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public FR = français 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public IT = italiano 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public LV = latviešu valoda 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public LT = lietuvių kalba 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public HU = magyar 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public MT = Malti 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public NL = Nederlands 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public PL = polski 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public PT = português 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public RO = română 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public SK = slovenčina 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public SL = slovenščina 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public FI = suomi 15/10/2007 28/01/2011
Celsentri : EPAR - Summary for the public SV = svenska 15/10/2007 28/01/2011

This EPAR was last updated on 08/08/2014 .

Authorisation details

Product details

Product details for Celsentri
NameCelsentri
Agency product numberEMEA/H/C/000811
Active substance

maraviroc

International non-proprietary name (INN) or common name

maraviroc

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AX09

Publication details

Publication details for Celsentri
Marketing-authorisation holder

ViiV Healthcare UK Limited

Revision15
Date of issue of marketing authorisation valid throughout the European Union18/09/2007

Contact address:

ViiV Healthcare UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Product information

Product information

25/04/2014  Celsentri -EMEA/H/C/000811 -WS/0544

Name Language First published Last updated
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014
Celsentri : EPAR - Product Information SV = svenska 11/08/2009 08/08/2014

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
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  
Celsentri : EPAR - All Authorised presentations SV = svenska 15/10/2007  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable.

This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials in treatment-experienced patients.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Celsentri : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 11/08/2009 08/08/2014
Celsentri-H-C-811-P46-35 : EPAR - Assessment Report SV = svenska 27/03/2013  
Celsentri-H-C-811-II-06 : EPAR - Assessment Report - Variation SV = svenska 07/01/2010  

Initial marketing-authorisation documents

Name Language First published Last updated
Celsentri : EPAR - Scientific Discussion SV = svenska 18/12/2007  
Celsentri : EPAR - Procedural steps taken before authorisation SV = svenska 15/10/2007  

Authorised

This medicine is approved for use in the European Union