Dolutegravir/rilpivirine

Last updated

Dolutegravir/rilpivirine
Combination of
Dolutegravir HIV integrase strand transfer inhibitor (INSTI)
Rilpivirine HIV non-nucleoside reverse-transcriptase inhibitor (NNRTI)
Clinical data
Trade names Juluca
AHFS/Drugs.com Monograph
License data
Pregnancy
category
Routes of
administration 		By mouth
ATC code
Legal status
Legal status
Identifiers
KEGG

Dolutegravir/rilpivirine, sold under the brand name Juluca, is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS. [9] [7] It contains the medicines dolutegravir and rilpivirine. [7] It is taken by mouth. [7]

The most common adverse reactions (of all severity grades) are diarrhea and headache. [7]

Dolutegravir/rilpivirine was approved for use in the United States in November 2017, [7] [10] [11] and for use in the European Union in May 2018. [8]

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. [8]

References

  1. ↑ "Dolutegravir / rilpivirine (Juluca) Use During Pregnancy". Drugs.com. 7 January 2020. Archived from the original on 25 March 2020. Retrieved 25 March 2020.
  2. 1 2 "TGA eBS - Product and Consumer Medicine Information Licence". Archived from the original on 14 February 2022. Retrieved 14 February 2022.
  3. ↑ "Juluca". NPS MedicineWise. 15 July 2021. Archived from the original on 14 February 2022. Retrieved 13 February 2022.
  4. ↑ "Regulatory Decision Summary for Juluca". Drug and Health Product Register. 23 October 2014. Archived from the original on 7 June 2022. Retrieved 7 June 2022.
  5. ↑ "Drug and medical device highlights 2018: Helping you maintain and improve your health". Health Canada . 14 October 2020. Archived from the original on 17 April 2024. Retrieved 17 April 2024.
  6. ↑ "Juluca 50 mg/25 mg film-coated tablets - Summary of Product Characteristics (SmPC)". (emc). 25 February 2020. Archived from the original on 25 March 2020. Retrieved 25 March 2020.
  7. 1 2 3 4 5 6 "Juluca- dolutegravir sodium and rilpivirine hydrochloride tablet, film coated". DailyMed. 24 October 2019. Archived from the original on 12 June 2020. Retrieved 25 March 2020.
  8. 1 2 3 "Juluca EPAR". European Medicines Agency (EMA). 11 February 2019. Archived from the original on 25 March 2020. Retrieved 25 March 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. ↑ Hester EK, Astle K (August 2019). "Dolutegravir-Rilpivirine, Dual Antiretroviral Therapy for the Treatment of HIV-1 Infection". The Annals of Pharmacotherapy. 53 (8): 860–866. doi:10.1177/1060028019831674. PMID   30758229. S2CID   73429093.
  10. ↑ "Drug Approval Package: Juluca (dolutegravir and rilpivirine)". U.S. Food and Drug Administration (FDA). 29 June 2018. Archived from the original on 25 March 2020. Retrieved 25 March 2020.
  11. ↑ "Juluca: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 15 August 2020. Retrieved 25 March 2020.
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