You are now leaving GSK’s website

This link will take you to a non-GSK website. GSK does not recommend, endorse or accept liability for sites controlled by third-parties.

Continue

Go back

Safety & Tolerability

JULUCA—2 Agents With the Tolerability You Expect

  • Patients switched to JULUCA had a median time on ART of 4.25 years1
  • 87% of subjects were new to both DTG and RPV2

Juluca is contraindicated for patients with hypersensitivity to the active substances or to any of the excipients.3

Co-administration with the following medicinal products is contraindicated:3

  • dofetilide;
  • carbamazepine, oxcarbazepine, phenobarbital, phenytoin;
  • rifampicin, rifapentine;
  • proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole;
  • systemic dexamethasone, except as a single dose treatment;
  • St John's wort (Hypericum perforatum).

Adverse events (AEs) with onset through Week 52 (pooled) (data from SWORD 1 and 2 studies)1

Juluca Safety & Tolerability Table

*Two deaths in the study, both unrelated to study drug. DTG + RPV: Kaposi's sarcoma (n=1), continued 3-drug regimen: lung cancer (n=1).1

Most common adverse events for Juluca:3

Based on data from Phase III clinical studies, the most frequently reported adverse reactions considered possibly or probably related to the combined administration of dolutegravir and rilpivirine were:
Diarrhoea (2%)
Headache (2%)

For further information, please see the Juluca Prescribing Information

References:

  1. Llibre JM, Hung C-C, Brinson C, et al. Lancet 2018;391:839–849.
  2. Oglesby A, Punekar Y, Angelis K, et al. EACS 2017; Milan, Italy. Poster BPD1/2.
  3. Juluca Summary of Product Characteristics.  Available from: www.medicines.ie. Last accessed: May 2018.

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@hpra.ie . Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Trade marks are owned by or licensed to the ViiV Healthcare group of companies.