Odefsey

emtricitabine / rilpivirine / tenofovir alafenamide

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

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

What is Odefsey and what is it used for?

Odefsey is an antiviral medicine used to treat adults and adolescents (aged over 12 years and weighing at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

Odefsey contains the active substances emtricitabine, rilpivirine and tenofovir alafenamide. It is only used in patients where the virus has not developed resistance to a class of HIV medicines called non-nucleoside reverse transcriptase inhibitors, tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.

How is Odefsey used?

The medicine can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection. Odefsey is available as tablets, each containing 200 mg emtricitabine, 25 mg rilpivirine, and 25 mg tenofovir alafenamide. The recommended dose is one tablet a day, taken with food.

How does Odefsey work?

Odefsey contains three active substances. Tenofovir alafenamide is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors. Rilpivirine is an antiviral agent called non-nucleoside reverse transcriptase inhibitor.

All three active substances block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected. By blocking this enzyme, Odefsey reduces the amount of HIV-1 in the blood and keeps it at a low level.

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

What benefits of Odefsey have been shown in studies?

The combination of active substances in Odefsey (emtricitabine, rilpivirine and tenofovir) is already approved in the EU as Eviplera to treat HIV-1 infection, although in Eviplera tenofovir is present as tenofovir disoproxil whereas in Odefsey it is present as tenofovir alafenamide.

To support the use of tenofovir alafenamide, the company provided data from studies showing that combination medicines containing tenofovir alafenamide are as effective in reducing the amount of HIV-1 in the blood as those containing tenofovir disoproxil.

In addition, to support its application, the company performed a ‘bioequivalence’ study comparing Odefsey with two other HIV medicines: Edurant (rilpivirine) and Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide). This study showed that Odefsey produces the same levels of rilpivirine in the body as Edurant, and the same levels of emtricitabine and tenofovir alafenamide as Genvoya. This means that the effects of these components in Odefsey should be similar to their effects in other medicines.

What are the risks associated with Odefsey?

The most common side effects seen with the active substance rilpivirine and with the combination of emtricitabine and tenofovir alafenamide (which may affect more than 1 in 10 people) are headache, dizziness and nausea (feeling sick). Very common side effects with rilpivirine also include increased cholesterol levels (total cholesterol and LDL-cholesterol), insomnia (difficulty sleeping) and increased liver and pancreas enzymes. For the full list of all side effects, see the package leaflet.

Odefsey must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Odefsey:

  • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);
  • rifabutin, rifampicin, rifapentine (antibiotics);
  • omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole (medicines for reducing stomach acid);
  • dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) except when used as a single dose treatment;
  • St John’s wort (a herbal preparation used for depression and anxiety).

For the full list of restrictions, see the package leaflet.

Why is Odefsey approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that Odefsey is an alternative treatment option to Eviplera with similar effectiveness. In terms of safety, tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil and may lead to reduced side effects in the kidneys and bones. The CHMP therefore decided that Odefsey’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 Odefsey?

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

Other information about Odefsey

The European Commission granted a marketing authorisation valid throughout the European Union for Odefsey on 21. June 2016.

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

Name Language First published Last updated
Odefsey : EPAR - Summary for the public BG = bălgarski 2016-07-08  
Odefsey : EPAR - Summary for the public ES = español 2016-07-08  
Odefsey : EPAR - Summary for the public CS = čeština 2016-07-08  
Odefsey : EPAR - Summary for the public DA = dansk 2016-07-08  
Odefsey : EPAR - Summary for the public DE = Deutsch 2016-07-08  
Odefsey : EPAR - Summary for the public ET = eesti keel 2016-07-08  
Odefsey : EPAR - Summary for the public EL = elliniká 2016-07-08  
Odefsey : EPAR - Summary for the public EN = English 2016-07-08  
Odefsey : EPAR - Summary for the public FR = français 2016-07-08  
Odefsey : EPAR - Summary for the public IT = italiano 2016-07-08  
Odefsey : EPAR - Summary for the public LV = latviešu valoda 2016-07-08  
Odefsey : EPAR - Summary for the public LT = lietuvių kalba 2016-07-08  
Odefsey : EPAR - Summary for the public HU = magyar 2016-07-08  
Odefsey : EPAR - Summary for the public NL = Nederlands 2016-07-08  
Odefsey : EPAR - Summary for the public PL = polski 2016-07-08  
Odefsey : EPAR - Summary for the public PT = português 2016-07-08  
Odefsey : EPAR - Summary for the public RO = română 2016-07-08  
Odefsey : EPAR - Summary for the public SK = slovenčina 2016-07-08  
Odefsey : EPAR - Summary for the public SL = slovenščina 2016-07-08  
Odefsey : EPAR - Summary for the public FI = suomi 2016-07-08  
Odefsey : EPAR - Summary for the public SV = svenska 2016-07-08  
Odefsey : EPAR - Summary for the public HR = Hrvatski 2016-07-08  

This EPAR was last updated on 22/08/2017 .

Authorisation details

Product details

Product details for Odefsey
NameOdefsey
Agency product numberEMEA/H/C/004156
Active substance

emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide

International non-proprietary name (INN) or common name

emtricitabine / rilpivirine / tenofovir alafenamide

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR19
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 Odefsey
Marketing-authorisation holder

Gilead Sciences International Ltd 

Revision7
Date of issue of marketing authorisation valid throughout the European Union21/06/2016

Contact address:

Gilead Sciences International Ltd
Granta Park
Abington
Cambridge
CB21 6GT
United Kingdom

Product information

Product information

06/07/2017  Odefsey -EMEA/H/C/004156 -WS/1136

Name Language First published Last updated
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22
Odefsey : EPAR - Product Information HR = Hrvatski 2016-07-08 2017-08-22

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
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  
Odefsey : EPAR - All Authorised presentations HR = Hrvatski 2016-07-08  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (HIV 1) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 HIV 1 RNA copies/mL.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Odefsey : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-11-29 2017-08-22

Initial marketing-authorisation documents

Name Language First published Last updated
Odefsey : EPAR - Public assessment report HR = Hrvatski 2016-07-08  
CHMP summary of opinion for Odefsey HR = Hrvatski 2016-04-29  

Authorised

This medicine is approved for use in the European Union