Prezista

darunavir

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This is a summary of the European public assessment report (EPAR) for Prezista. 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 Prezista.

What is Prezista?

Prezista is a medicine that contains the active substance darunavir. It is available as tablets (75, 150, 300, 400, 600, and 800 mg) and as an oral suspension (100 mg/ml).

What is Prezista used for?

Prezista is used together with low-dose ritonavir and other antiviral medicines to treat adults and children aged three years or over who are infected with human immunodeficiency virus (HIV‑1), a virus that causes acquired immune deficiency syndrome (AIDS).

The medicine can only be obtained with a prescription.

How is Prezista used?

Treatment with Prezista should be started by a healthcare professional who has experience in the management of HIV infection. The medicine is always taken with ritonavir and other anti-HIV medicines and should be taken with food.

For adults who have not been treated before, the recommended dose is 800 mg once a day. For adults who have been treated before, the dose is 600 mg twice a day. A dose of 800 mg once a day can also be taken by previously treated patients, provided that the patients are healthy enough and that the HIV virus causing their infection has been shown not to be resistant to Prezista.

For previously treated children (ages 3 years and above) the dose varies between 380 and 600 mg twice a day depending on their weight. Depending on the levels of white blood cells and the HIV virus in the blood,some previously treated children aged 12 to 17 and weighing at least 40 kg may be given 800 mg once a day, if their infection is not resistant to Prezista.

For previously untreated children aged from 12 to 17 years and weighing at least 40 kg, the recommended dose is 800 mg once a day.

The oral suspension is available for patients unable to swallow the tablets.

How does Prezista work?

The active substance in Prezista, darunavir, is a protease inhibitor. It blocks an enzyme called protease, which is involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally, slowing down the rate of replication. Ritonavir is another protease inhibitor that is used as a ‘booster’. It slows down the rate at which darunavir is broken down, increasing the levels of darunavir in the blood. This allows a lower dose of darunavir to be used for the same antiviral effect.

Prezista, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Prezista does not cure HIV infection or AIDS, but it may delay or reverse the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Prezista been studied?

In adults, Prezista has been studied in five main studies. One study compared ritonavir-boosted Prezista 800 mg once a day with ritonavir-boosted lopinavir (another protease inhibitor) in 691 adults who had not been treated for HIV before.

Three studies involved adults who had been treated before who received 600 mg Prezista twice a day. One study compared ritonavir-boosted Prezista with ritonavir-boosted lopinavir in 604 patients who had taken some anti‑HIV medicines in the past. The other two studies compared ritonavir-boosted Prezista with other protease inhibitors chosen on the basis of the patient’s previous treatments and predicted response, in a total of 628 patients who had taken many anti‑HIV medicines in the past.

The fifth study involved 590 adults who had been treated before and compared Prezista 800 mg once a day with Prezista 600 mg twice a day.

Ritonavir-boosted Prezista has also been studied in 101 previously treated children aged between three and 18 years and 12 previously untreated children aged between 12 to 18 years who weighed at least 40 kg

In all of the studies, the patients also took other anti‑HIV medicines. The main measures of effectiveness were based on the change in HIV levels in the blood (viral load).

What benefit has Prezista shown during the studies?

In adults who had not been treated before, Prezista was as effective as lopinavir. After 48 weeks, 84% of the patients taking ritonavir-boosted Prezista had viral loads below 50 copies/ml (287 out of 343) compared with 78% of those taking ritonavir-boosted lopinavir (271 out of 346).

In adults who had been treated before, those taking Prezista achieved lower viral loads than those taking the comparator protease inhibitors. In patients who had taken some anti‑HIV medicines in the past, 77% of those taking ritonavir-boosted Prezista had viral loads below 400 copies/ml after 48 weeks, compared with 68% of those taking ritonavir-boosted lopinavir. In adults who had received many anti‑HIV medicines in the past, 70% of those taking the approved dose of ritonavir-boosted Prezista (92 out of 131) had at least a 90% reduction in viral load after 24 weeks, compared with 21% of those taking the comparator protease inhibitors (26 out of 124).

Prezista 800 mg once a day was as effective as Prezista 600 mg twice a day in patients who had been treated before: after 48 weeks, 72% of the patients taking Prezista 800 mg once day had viral loads below 50 copies/ml (212 out of 294) compared with 71% of those taking Prezista 600 mg twice a day (210 out of 296).

Prezista was also effective in previously treated children: 74% of the previously treated children aged above six years (59 out of 80) had at least a 90% reduction in viral loads after 24 weeks of treatment; 81% of those aged between three and six (17 out of 21) had viral loads below 50 copies/ml after 48 weeks.

In the study of previously untreated children, 83% (10 out of 12) had viral loads below 50 copies/ml after 48 weeks of treatment.

What is the risk associated with Prezista?

In adults, the most common side effects with Prezista are diarrhoea, ‘immune reconstitution syndrome’, nausea (feeling sick), pyrexia (fever) and rash. Immune reconstitution syndrome happens when the patient’s immune system starts working again and fights existing infections, causing inflammation at the site of the infection. Side effects are similar in children and adolescents. For the full list of all side effects reported with Prezista, see the package leaflet.

Prezista must not be taken by patients who are hypersensitive (allergic) to darunavir or any of the other ingredients. It must not be taken by patients who have severe problems with their liver, or who are taking the following medicines:

  • rifampicin (used to treat tuberculosis);
  • ritonavir-boosted lopinavir;
  • St John’s wort (a herbal preparation used to treat depression);
  • medicines that are broken down in the same way as Prezista and are harmful at high levels in the blood. See the package leaflet for the full list of these medicines.

The 300‑ and 600‑mg tablets contain a colouring agent called sunset yellow (E110), which can cause allergies. Patients who are allergic to this agent may need to take the lower strength tablets, which do not contain sunset yellow.

Why has Prezista been approved?

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

Other information about Prezista

The European Commission granted a marketing authorisation valid throughout the European Union for Prezista on 12 February 2007.

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

Name Language First published Last updated
Prezista : EPAR - Summary for the public BG = bălgarski 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public ES = español 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public CS = čeština 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public DA = dansk 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public DE = Deutsch 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public ET = eesti keel 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public EL = elliniká 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public EN = English 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public FR = français 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public IT = italiano 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public LV = latviešu valoda 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public LT = lietuvių kalba 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public HU = magyar 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public MT = Malti 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public NL = Nederlands 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public PL = polski 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public PT = português 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public RO = română 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public SK = slovenčina 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public SL = slovenščina 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public FI = suomi 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public SV = svenska 10/07/2009 28/11/2014
Prezista : EPAR - Summary for the public HR = Hrvatski 10/07/2009 28/11/2014

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

Authorisation details

Product details

Product details for Prezista
NamePrezista
Agency product numberEMEA/H/C/000707
Active substance

darunavir

International non-proprietary name (INN) or common name

darunavir

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AE10

Publication details

Publication details for Prezista
Marketing-authorisation holder

Janssen-Cilag International NV

Revision38
Date of issue of marketing authorisation valid throughout the European Union12/02/2007

Contact address:

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

Product information

Product information

22/04/2016  Prezista -EMEA/H/C/000707 -N/0080

Name Language First published Last updated
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 11/05/2016
Prezista : EPAR - Product Information HR = Hrvatski 05/11/2009 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
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013
Prezista : EPAR - All Authorised presentations HR = Hrvatski 10/07/2009 19/06/2013

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Prezista filLondon (LGW)m-coated tablets co-administered with low-dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human-immunodeficiency-virus (HIV-1) infection.

Prezista 75/150/300/600 mg tablets may be used to provide suitable dose regimens: 

  • for the treatment of HIV-1 infection in antiretroviral-treatment (ART)-experienced adult patients, including those that have been highly pretreated;
  • for the treatment of HIV‑1 infection in paediatric patients from the age of three years and at least 15 kg body weight.

Prezista 400/800 mg tablets co‑administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adult patients.

Prezista 400/800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV‑1 infection in adult and paediatric patients from the age of 12 years and at least 40 kg body weight who are:

  • antiretroviral therapy (ART)‑naïve;
  • ART‑experienced with no darunavir resistance associated mutations (DRV‑RAMs) and who have plasma HIV‑1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with Prezista in such ART‑experienced patients, genotypic testing should guide the use of Prezista.

Prezista 100-mg/ml oral suspension co‑administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.

Prezista 100-mg/ml oral suspension co‑administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adult patients.

In deciding to initiate treatment with Prezista co‑administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Prezista.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Prezista : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 05/11/2009 11/05/2016
Prezista-H-C-707-P46-071 : EPAR - Assessment report HR = Hrvatski 05/01/2016  
Prezista-H-C-707-P46-0064 : EPAR - Assessment Report HR = Hrvatski 07/04/2015  
Prezista-H-C-707-P46-0066 : EPAR - Assessment Report HR = Hrvatski 07/04/2015  
CHMP post-authorisation summary of positive opinion for Prezista HR = Hrvatski 26/09/2014 09/02/2015
CHMP post-authorisation summary of positive opinion for Prezista HR = Hrvatski 26/09/2014 09/02/2015
Prezista-H-C-707-II-0063 : EPAR - Assessment Report - Variation HR = Hrvatski 01/12/2014  
Prezista-H-C-707-II-0064 : EPAR - Assessment Report - Variation HR = Hrvatski 28/11/2014  
Prezista-H-C-707-II-0054 : EPAR - Assessment Report - Variation HR = Hrvatski 29/10/2013  
Prezista : EPAR - Paediatric investigation plan compliance statement HR = Hrvatski 29/10/2013  
Prezista-H-C-707-PSU-0059 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation HR = Hrvatski 29/10/2013  
Prezista-H-C-707-X-0046 : EPAR - Assessment Report - Extension HR = Hrvatski 20/09/2013  
CHMP post-authorisation summary of positive opinion for Prezista HR = Hrvatski 26/07/2013  
Prezista-H-C-707-P46-0063 : EPAR - Assessment Report HR = Hrvatski 27/03/2013  
Prezista-H-C-707-X-0041-G : EPAR - Assessment Report - Extension HR = Hrvatski 14/11/2012  
CHMP post-authorisation summary of positive opinion for Prezista HR = Hrvatski 20/07/2012  
Prezista-H-C-707-II-0032 : EPAR - Assessment Report - Variation HR = Hrvatski 22/03/2011  
CHMP post-authorisation summary of positive opinion for Prezista HR = Hrvatski 21/01/2011  
Prezista-H-C-707-X-0020-0021 : EPAR - Assessment Report - Extension HR = Hrvatski 10/07/2009  
CHMP post-authorisation summary of positive opinion for Prezista on 23 April 2009 HR = Hrvatski 23/04/2009  
Prezista-H-C-707-X-0016 : EPAR - Assessment Report - Extension HR = Hrvatski 12/02/2009  
Prezista-H-C-707-II-0014 : EPAR - Assessment Report - Variation HR = Hrvatski 16/12/2008  
CHMP post-authorisation summary of positive opinion for Prezista on 20 November 2008 HR = Hrvatski 20/11/2008  
CHMP post-authorisation summary of positive opinion for Prezista on 23 October 2008 HR = Hrvatski 23/10/2008  

Initial marketing-authorisation documents

Name Language First published Last updated
Prezista : EPAR - Procedural steps taken before authorisation HR = Hrvatski 25/11/2008  
Prezista : EPAR - Scientific Discussion HR = Hrvatski 25/11/2008