Dolutegravir/rilpivirine explained

Type:combo
Component1:Dolutegravir
Class1:HIV integrase strand transfer inhibitor (INSTI)
Component2:Rilpivirine
Class2:HIV non-nucleoside reverse-transcriptase inhibitor (NNRTI)
Tradename:Juluca
Dailymedid:Juluca
Pregnancy Au:B1
Pregnancy Au Comment:[1]
Routes Of Administration:By mouth
Atc Prefix:J05
Atc Suffix:AR21
Legal Au:S4
Legal Au Comment:[2] [3]
Legal Ca:Rx-only
Legal Ca Comment:[4] [5]
Legal Uk:POM
Legal Uk Comment:[6]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Status:Rx-only
Kegg:D11282

Dolutegravir/rilpivirine, sold under the brand name Juluca, is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS.[7] It contains the medicines dolutegravir and rilpivirine. It is taken by mouth.

The most common adverse reactions (of all severity grades) are diarrhea and headache.

Dolutegravir/rilpivirine was approved for use in the United States in November 2017,[8] [9] [10] and for use in the European Union in May 2018.[11] __TOC__

Medical uses

Dolutegravir/rilpivirine 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.

Notes and References

  1. Web site: Dolutegravir / rilpivirine (Juluca) Use During Pregnancy . Drugs.com . 7 January 2020 . 25 March 2020 . 25 March 2020 . https://web.archive.org/web/20200325190543/https://www.drugs.com/pregnancy/dolutegravir-rilpivirine.html . live .
  2. Web site: Juluca . NPS MedicineWise . 15 July 2021 . 13 February 2022 . 14 February 2022 . https://web.archive.org/web/20220214020912/https://www.nps.org.au/medicine-finder/juluca#full-pi . live .
  3. Web site: TGA eBS - Product and Consumer Medicine Information Licence . 14 February 2022 . 14 February 2022 . https://web.archive.org/web/20220214015418/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-PI-01956-1 . live .
  4. Web site: Regulatory Decision Summary for Juluca . Drug and Health Product Register . 23 October 2014 . 7 June 2022 . 7 June 2022 . https://web.archive.org/web/20220607071913/https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00438 . live .
  5. Web site: Drug and medical device highlights 2018: Helping you maintain and improve your health . . 14 October 2020 . 17 April 2024 . 17 April 2024 . https://web.archive.org/web/20240417063539/https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2018.html . live .
  6. Web site: Juluca 50 mg/25 mg film-coated tablets - Summary of Product Characteristics (SmPC) . (emc) . 25 February 2020 . 25 March 2020 . 25 March 2020 . https://web.archive.org/web/20200325190542/https://www.medicines.org.uk/emc/product/9246/smpc . live .
  7. Hester EK, Astle K . Dolutegravir-Rilpivirine, Dual Antiretroviral Therapy for the Treatment of HIV-1 Infection . The Annals of Pharmacotherapy . 53 . 8 . 860–866 . August 2019 . 30758229 . 10.1177/1060028019831674 . 73429093 .
  8. Web site: Juluca- dolutegravir sodium and rilpivirine hydrochloride tablet, film coated . DailyMed . 24 October 2019 . 25 March 2020 . 12 June 2020 . https://web.archive.org/web/20200612235833/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=806653d1-bf35-4924-b999-ad5d21821cc1 . live .
  9. Web site: Drug Approval Package: Juluca (dolutegravir and rilpivirine) . U.S. Food and Drug Administration (FDA) . 29 June 2018 . 25 March 2020 . 25 March 2020 . https://web.archive.org/web/20200325190543/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/210192Orig1s000TOC.cfm . live .
  10. Web site: Juluca: FDA-Approved Drugs . U.S. Food and Drug Administration (FDA) . 25 March 2020 . 15 August 2020 . https://web.archive.org/web/20200815020710/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210192 . live .
  11. Web site: Juluca EPAR . European Medicines Agency (EMA) . 11 February 2019 . 25 March 2020 . 25 March 2020 . https://web.archive.org/web/20200325190542/https://www.ema.europa.eu/en/medicines/human/EPAR/juluca . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Dolutegravir/rilpivirine".

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