JULUCA®

Juluca is ViiV Healthcare’s first 2-drug regimen, once-daily, single-pill that combines the integrase inhibitor (IN) dolutegravir, with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine.

Juluca was approved by the US Food and Drug Administration (FDA) on 21st November 2017 as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.1

On 16th May 2018, the European Commission (EC) approved Juluca 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.2 Marketing authorisation was also granted by Health Canada on 18th May 2018.3

Regulatory applications are on-going in other markets worldwide.

[1] Juluca US label information

[2] Juluca European label information

[3] Juluca Canadian label information

 

Prescribing information

Please refer to your country-specific information below:

Canada

Product Monograph for Juluca/

Monographie de Juluca

Safety Information / Renseignements sur
l’innocuité

Healthcare Professional Letter for Juluca /
Lettre aux professionnels de la santé surJuluca

Europe

European Summary of Product Information

United States

Prescribing Information and Patient
Information Leaflet for Juluca®

 

▼ This medicine is subject to additional monitoring. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.