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dolutegravir

Tivicay · ATC code J05AX12

Key facts
Active substance
dolutegravir
Drug class
Enisamium iodide
ATC code
J05AX12
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Tivicay 10 mg film-coated tablets / Tivicay 25 mg film-coated tablets / Tivicay 50 mg film-coated tablets · Tivicay 5 mg dispersible tablets
Marketing authorisation holder
ViiV Healthcare BV
Information as of
2026-10-28

Key facts

Dolutegravir (Tivicay) is an HIV integrase inhibitor used in combination with other antiretroviral medicines to treat HIV infection.

What it is used for

  • HIV infection in combination with other antiretrovirals: film-coated tablets in adults, adolescents and children aged at least 6 years and weighing at least 14 kg; 5 mg dispersible tablets from 4 weeks of age and at least 3 kg.

Dosing

  • Film-coated tablets, adults without integrase resistance: 50 mg once daily; twice daily when co-administered with e.g. efavirenz, nevirapine, tipranavir/ritonavir or rifampicin.
  • Film-coated tablets, adults with (suspected) integrase class resistance: 50 mg twice daily.
  • Film-coated tablets, adolescents aged 12 and above weighing at least 20 kg: 50 mg once daily (or 25 mg twice daily); children aged 6 and above: 14 to less than 20 kg 40 mg, 20 kg or greater 50 mg once daily.
  • Dispersible tablets: adults 30 mg (six 5 mg dispersible tablets) once daily, twice daily with resistance; infants and children by weight and age (see the full text).
  • Film-coated and dispersible tablets are not interchangeable on a milligram per milligram basis.
  • No dose adjustment in renal impairment or mild to moderate hepatic impairment; caution in severe hepatic impairment.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Co-administration with OCT2 substrates with narrow therapeutic windows, e.g. fampridine (dalfampridine).

Important warnings

  • Hypersensitivity reactions with rash, constitutional findings and sometimes organ dysfunction including severe liver reactions; discontinue immediately if signs develop.
  • Activity is considerably compromised for viruses with Q148 plus two secondary mutations.
  • Dolutegravir increases metformin concentrations; consider metformin dose adjustment and monitor renal function (lactic acidosis risk in moderate renal impairment).
  • Immune reactivation syndrome and osteonecrosis have been reported.

Side effects

  • Most common: diarrhoea (18%), nausea (13%) and headache (13%).
  • Common: insomnia, abnormal dreams, depression, anxiety, dizziness, vomiting, flatulence, upper abdominal pain.
  • Uncommon: hypersensitivity, suicidal ideation (particularly with a psychiatric history); the most severe reaction was a hypersensitivity reaction with severe liver effects.

Interactions

  • Magnesium/aluminium-containing antacids should be taken at least 2 hours after or 6 hours before dolutegravir; calcium, iron and magnesium supplements likewise when fasting, or together with dolutegravir and food.
  • Inducers such as rifampicin, efavirenz or St John's wort lower dolutegravir levels.
  • Metformin levels rise (AUC by 79% with 50 mg once daily).

Pregnancy and breastfeeding

  • Can be used during pregnancy if clinically needed; large datasets do not indicate an increased risk of neural tube defects.
  • Women living with HIV are recommended not to breast-feed to avoid transmission.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • TivicayViiV Healthcare BV · EMEA/H/C/002753

Source: European Medicines Agency (EMA), product information

Turkey

  • DolusevHUMANİS SAĞLIK A.Ş. · 1 register entry
  • TivicayGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 6 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 6 more European countries
Cyprus
Dogrivio
Greece
Dogrivio
Iceland
Tivicay
Liechtenstein
Tivicay
Norway
Dolutegravir Teva, Tivicay
Sweden
Dogrivio, Dolutegravir Elpen, Dolutegravir Win Medica

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Tivicay – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/tivicay-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC J05AX.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.