Symtuza

darunavir / cobicistat / emtricitabine / tenofovir alafenamide

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

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

What is Symtuza and what is it used for?

Symtuza is an antiviral medicine used to treat human immunodeficiency virus type 1 (HIV-1) in adults and adolescents (aged over 12 years and weighing at least 40 kg). HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).

Symtuza contains the active substances darunavir, cobicistat, emtricitabine and tenofovir alafenamide.

How is Symtuza used?

Symtuza can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.

Symtuza is available as tablets, each containing 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide. The recommended dose is one tablet a day, taken with food.

For further information, see the package leaflet.

How does Symtuza work?

Symtuza contains four active substances which work in different ways against HIV:

  • Darunavir is a type of antiviral agent called a ‘protease inhibitor’. It blocks protease, an enzyme of the virus that allows it to reproduce itself in the cells it has infected. By blocking protease, Symtuza reduces the amount of HIV-1 in the blood and keeps it at a low level.
  • Cobicistat acts as a ‘booster’ to enhance the effects of darunavir, by slowing down the breakdown of darunavir and therefore prolonging the time it acts in the body.
  • Tenofovir alafenamide is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a reverse transcriptase inhibitor, which means that it blocks the activity of reverse transcriptase, another enzyme of the virus that allows it to reproduce itself.
  • Emtricitabine is a reverse transcriptase inhibitor and it works in the same way as tenofovir.

Symtuza does not cure HIV-1 infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.

Darunavir and cobicistat are authorised as Rezolsta. Emtricitabine and tenofovir alafenamide are authorised as Descovy.

What benefits of Symtuza have been shown in studies?

Because the individual active substances of Symtuza have previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Symtuza produced similar levels of active substances in the blood to the active substances given separately.

In addition, one main study was carried out to compare Symtuza with another antiviral medicine containing darunavir, cobicistat, emtricitabine and tenofovir disoproxil in 153 adult patients with HIV who had not been previously treated. Effectiveness was measured by a reduction in viral load (the amount of HIV-1 in the blood) to less than 50 copies/ml. Overall, 75% of patients taking Symtuza (77 patients out of 103) achieved this reduction after 24 weeks of treatment, which was comparable to the 74% (37 of 50) of patients who achieved it with the comparator.

What are the risks associated with Symtuza?

The most common side effects with Symtuza (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), tiredness, headache and rash. For the full list of side effects reported with Symtuza, see the package leaflet.

Symtuza must not be taken by patients with severely reduced liver function. It must also not be taken with certain medicines that may reduce the effectiveness of Symtuza, as well as medicines that may increase the risk of serious side effects. For more information on the medicines that should not be taken with Symtuza, see the package leaflet.

Why is Symtuza approved?

The active substances in Symtuza have already been shown to be effective when used individually, and combining them in a single tablet simplifies treatment. Symtuza has also been shown to be as effective as a similar combination medicine containing tenofovir disoproxil in place of tenofovir alafenamide. Because tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil, Symtuza offers the possibility of reduced side effects.

The Agency decided that Symtuza’s benefits are greater than its risks and recommended that it be approved for use in the EU.

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

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

Other information about Symtuza

The European Commission granted a marketing authorisation valid throughout the European Union for Symtuza on 21 September 2017.

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

Name Language First published Last updated
Symtuza : EPAR - Summary for the public BG = bălgarski 2017-09-26  
Symtuza : EPAR - Summary for the public ES = español 2017-09-26  
Symtuza : EPAR - Summary for the public CS = čeština 2017-09-26  
Symtuza : EPAR - Summary for the public DA = dansk 2017-09-26  
Symtuza : EPAR - Summary for the public DE = Deutsch 2017-09-26  
Symtuza : EPAR - Summary for the public ET = eesti keel 2017-09-26  
Symtuza : EPAR - Summary for the public EL = elliniká 2017-09-26  
Symtuza : EPAR - Summary for the public EN = English 2017-09-26  
Symtuza : EPAR - Summary for the public FR = français 2017-09-26  
Symtuza : EPAR - Summary for the public IT = italiano 2017-09-26  
Symtuza : EPAR - Summary for the public LV = latviešu valoda 2017-09-26  
Symtuza : EPAR - Summary for the public LT = lietuvių kalba 2017-09-26  
Symtuza : EPAR - Summary for the public HU = magyar 2017-09-26  
Symtuza : EPAR - Summary for the public MT = Malti 2017-09-26  
Symtuza : EPAR - Summary for the public NL = Nederlands 2017-09-26  
Symtuza : EPAR - Summary for the public PL = polski 2017-09-26  
Symtuza : EPAR - Summary for the public PT = português 2017-09-26  
Symtuza : EPAR - Summary for the public RO = română 2017-09-26  
Symtuza : EPAR - Summary for the public SK = slovenčina 2017-09-26  
Symtuza : EPAR - Summary for the public SL = slovenščina 2017-09-26  
Symtuza : EPAR - Summary for the public FI = suomi 2017-09-26  
Symtuza : EPAR - Summary for the public SV = svenska 2017-09-26  
Symtuza : EPAR - Summary for the public HR = Hrvatski 2017-09-26  

This EPAR was last updated on 26/09/2017 .

Authorisation details

Product details

Product details for Symtuza
NameSymtuza
Agency product numberEMEA/H/C/004391
Active substance

darunavir / cobicistat / emtricitabine / tenofovir alafenamide

International non-proprietary name (INN) or common name

darunavir / cobicistat / emtricitabine / tenofovir alafenamide

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Symtuza
Marketing-authorisation holder

Janssen-Cilag International N.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union21/09/2017

Contact address:

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse 
Belgium

Product information

Product information

21/09/2017  Symtuza -EMEA/H/C/004391 --

Name Language First published Last updated
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03
Symtuza : EPAR - Product Information HR = Hrvatski 2017-09-26 2017-10-03

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
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  
Symtuza : EPAR - All Authorised presentations HR = Hrvatski 2017-09-26  

Pharmacotherapeutic group

Antivirals for systemic use, antivirals for treatment of HIV infection, combinations

Therapeutic indication

Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg).

Genotypic testing should guide the use of Symtuza (see sections 4.2 and 5.1).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Symtuza : EPAR - Public assessment report HR = Hrvatski 2017-09-26  
CHMP summary of positive opinion for Symtuza HR = Hrvatski 2017-07-21  

Authorised

This medicine is approved for use in the European Union