Juluca

dolutegravir / rilpivirine

  • Email
  • Help

About

An overview of Juluca and why it is authorised in the EU

Juluca is a HIV medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

Juluca is only used for patients whose levels of HIV-1 in the blood (viral load) have been below 50 copies/ml for at least 6 months on their current HIV treatment combination. It is not suitable for patients in whom any HIV medicine has stopped working or who are infected with HIV that is resistant to medicines that work in the same way as Juluca's active substances.

The active substances in Juluca are dolutegravir and rilpivirine.

How is Juluca used?

Juluca can only be obtained with a prescription and it should be prescribed by doctors experienced in managing HIV infection.

The recommended dose is one tablet once daily with a meal. For more information about using Juluca, see the package leaflet or contact your doctor or pharmacist.

How does Juluca work?

The two active substances in Juluca, dolutegravir and rilpivirine, block the actions of enzymes that the HIV needs to make copies of itself in the cells it has infected. Dolutegravir, an integrase inhibitor, blocks an enzyme called integrase while rilpivirine, a non-nucleoside reverse-transcriptase inhibitor, blocks the activity of another enzyme called reverse transcriptase.

In this way, Juluca helps to prevent the spread of HIV-1 and keep the amount of the virus in the blood at a low level. It does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.

Both active substances are already available in the European Union: dolutegravir has been authorised since 2014 and rilpivirine has been authorised since 2011.

What benefits of Juluca have been shown in studies?

Two main studies found that the combination of dolutegravir and rilpivirine (the active substances in Juluca) was effective for keeping HIV infection under control. The studies involved a total of 1,028 patients whose HIV infection was well controlled for at least 6 months on a combination of three HIV medicines that included a class of HIV medicines called nucleoside (or nucleotide) reverse transcriptase inhibitors (NRTIs). The studies compared the effectiveness of switching to the combination of dolutegravir and rilpivirine with that of remaining on the current combination of HIV medicines. The proportion of patients whose viral load was below 50 copies/ml after 48 weeks was the same for patients switching compared with those remaining on the current medicines (95% in both cases).

What are the risks associated with Juluca?

The most common side effects with Juluca are diarrhoea and headache. The most serious side effects (which may affect up to 1 in 100) include allergic reactions that include rash or liver damage.

Juluca must not be used with the following medicines because they may reduce its effectiveness:

  • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);
  • rifampicin, rifapentine (antibiotics);
  • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
  • dexamethasone given by mouth or by injection (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single-dose treatment;
  • St John’s wort (a herbal medicine used for treating depression).

For the full list of restrictions and side effects of Juluca, see the package leaflet.

Why is Juluca authorised in the EU?

The European Medicines Agency considered that Juluca’s effectiveness was comparable to that of combination treatment with three HIV medicines that include NRTIs. Because Juluca does not contain an NRTI, it is free of long-term side effects caused by NRTIs. The side effects of Juluca are well known and manageable.

The Agency decided that Juluca’s benefits are greater than its risks and it can be authorised for use in the EU.

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

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

As for all medicines, data on the use of Juluca are continuously monitored. Side effects reported with Juluca are carefully evaluated and any necessary action taken to protect patients.

Other information about JulucaFurther information on Juluca can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.

Further information on Juluca can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.

Name Language First published Last updated
Juluca : EPAR - Medicine overview BG = bălgarski 2018-05-24  
Juluca : EPAR - Medicine overview ES = español 2018-05-24  
Juluca : EPAR - Medicine overview CS = čeština 2018-05-24  
Juluca : EPAR - Medicine overview DA = dansk 2018-05-24  
Juluca : EPAR - Medicine overview DE = Deutsch 2018-05-24  
Juluca : EPAR - Medicine overview ET = eesti keel 2018-05-24  
Juluca : EPAR - Medicine overview EL = elliniká 2018-05-24  
Juluca : EPAR - Medicine overview EN = English 2018-05-24  
Juluca : EPAR - Medicine overview FR = français 2018-05-24  
Juluca : EPAR - Medicine overview IT = italiano 2018-05-24  
Juluca : EPAR - Medicine overview LV = latviešu valoda 2018-05-24  
Juluca : EPAR - Medicine overview LT = lietuvių kalba 2018-05-24  
Juluca : EPAR - Medicine overview HU = magyar 2018-05-24  
Juluca : EPAR - Medicine overview MT = Malti 2018-05-24  
Juluca : EPAR - Medicine overview NL = Nederlands 2018-05-24  
Juluca : EPAR - Medicine overview PL = polski 2018-05-24  
Juluca : EPAR - Medicine overview PT = português 2018-05-24  
Juluca : EPAR - Medicine overview RO = română 2018-05-24  
Juluca : EPAR - Medicine overview SK = slovenčina 2018-05-24  
Juluca : EPAR - Medicine overview SL = slovenščina 2018-05-24  
Juluca : EPAR - Medicine overview FI = suomi 2018-05-24  
Juluca : EPAR - Medicine overview SV = svenska 2018-05-24  
Juluca : EPAR - Medicine overview HR = Hrvatski 2018-05-24  
Name Language First published Last updated
Juluca : EPAR - Risk-management-plan summary (English only) 2018-05-24  

This EPAR was last updated on 24/05/2018 .

Authorisation details

Product details

Product details for Juluca
NameJuluca
Agency product numberEMEA/H/C/004427
Active substance

 dolutegravir sodium,rilpivirine hydrochloride

International non-proprietary name (INN) or common name

dolutegravir / rilpivirine

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR
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 Juluca
Marketing-authorisation holder

ViiV Healthcare UK Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union16/05/2018

Contact address:

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

Product information

Product information

16/05/2018  Juluca -EMEA/H/C/004427 --

Name Language First published Last updated
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  
Juluca : EPAR - Product Information EN = English 2018-05-24  

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
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  
Juluca : EPAR - All Authorised presentations EN = English 2018-05-24  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Juluca : EPAR - Public assessment report EN = English 2018-05-24  
CHMP summary of positive opinion for Juluca EN = English 2018-03-23