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Integrase strand-transfer inhibitor (INSTI) — antiretroviral Pregnancy: Tivicay can be used during pregnancy if clinically needed. A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity. Two large birth outcome surveillance studies (over 14,000 pregnancy outcomes) in Botswana (Tsepamo) and Eswatini, and other sources, do not indicate an increased risk for neural tube defects after dolutegravir exposure. The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births (0.05-0.1%). Data from the Tsepamo study show no significant difference in the prevalence of neural tube defects (0.11%) in infants whose mothers were taking dolutegravir at conception (over 9,400 exposures) compared to those taking non-dolutegravir containing antiretroviral regimens at conception (0.11%), or compared to women without HIV (0.07%). Data from the Eswatini study show the same prevalence of neural tube defects (0.08%) in infants whose mothers were taking dolutegravir at conception (over 4,800 exposures), as infants of women without HIV (0.08%). Data analysed from the Antiretroviral Pregnancy Registry (APR) of more than 1000 pregnancies with first trimester dolutegravir treatment do not indicate an increased risk of major birth defects compared to the background rate or women with HIV. In animal reproductive toxicity studies, no adverse development outcomes, including neural tube defects, were identified (see section 5.3). Dolutegravir crosses the placenta in humans. In pregnant women living with HIV, the median foetal umbilical cord concentration of dolutegravir was approximately 1.3-fold greater compared with the maternal peripheral plasma concentration. There is insufficient information on the effects of dolutegravir on neonates. Breast-feeding: Dolutegravir is excreted in human milk in small amounts (a median dolutegravir breast milk to maternal plasma ratio of 0.033 has been shown). There is insufficient information on the effects of dolutegravir in neonates/infants. It is recommended that women living with HIV do not breast-feed their infants in order to avoid transmission of HIV. Fertility: There are no data on the effects of dolutegravir on human male or female fertility. Animal studies indicate no effects of dolutegravir on male or female fertility (see section 5.3).

Dolutegravir

Brand names: Tivicay, Triumeq (with abacavir + lamivudine), Juluca (with rilpivirine), Dovato (with lamivudine)

Dolutegravir is an HIV integrase strand transfer inhibitor used as part of combination antiretroviral therapy for HIV infection.

Adult dose

Dose: Adults, HIV-1 infection in combination with other antiretroviral medicinal products — without documented or clinically suspected resistance to the integrase class: 50 mg orally once daily. The label says dolutegravir should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin); no per-dose figure is printed in that sentence (see section 4.5, not retrieved). With documented or clinically suspected resistance to the integrase class: 50 mg twice daily.
Route: Oral (film-coated tablets)
Frequency: Once daily; twice daily if integrase-class resistance (documented or clinically suspected) or when co-administered with efavirenz, nevirapine, tipranavir/ritonavir or rifampicin
The pinned product 'Tivicay 50 mg Film-Coated Tablets' §4.1 covers HIV-infected adults, adolescents and children of at least 6 years and at least 14 kg, in combination with other antiretrovirals; oral route and adult population match, so a dose is written. SCOPE: this card is the single-agent dolutegravir film-coated tablet (Tivicay). The fixed-dose combination brands on the page (Triumeq, Juluca, Dovato) are separate products with their own labels and are NOT covered. NO MAXIMUM DOSE is written: none is printed. For documented Q148 + >=2 secondary mutations (G140A/C/S, E138A/K/T, L74I) the label says only that "an increased dose may be considered for patients with limited treatment options (less than 2 active agents)" and prints no figure. ELDERLY: "There is no evidence that elderly patients require a different dose than younger adult patients". ADMINISTRATION: "Tivicay can be taken with or without food"; "In the presence of integrase class resistance, Tivicay should preferably be taken with food to enhance exposure". MISSED DOSE: take as soon as possible, providing the next dose is not due within 4 hours; if it is due within 4 hours, skip the missed dose. CATIONS (§4.4): when taken with food, Tivicay and supplements or multivitamins containing calcium, iron or magnesium can be taken at the same time; under fasting conditions take such supplements 2 hours after or 6 hours before Tivicay. FORMULATION: dispersible tablets are a different formulation, "not interchangeable on a milligram per milligram basis" with film-coated tablets, and are not covered by this card. "To reduce the risk of choking, patients should not swallow more than one tablet at a time". Prescribe by a physician experienced in the management of HIV infection. Section 4.5 was not retrieved, so the drug-interaction detail behind the twice-daily rule is not available here.

Paediatric dose

Dose: Film-coated tablets, HIV-1 without integrase-class resistance. Adolescents aged 12 and above to less than 18 years, weighing at least 20 kg: 50 mg once daily; alternatively, if preferred, 25 mg twice daily. Children aged 6 and above to less than 12 years, weighing at least 14 kg: 14 to less than 20 kg — 40 mg once daily (alternatively 20 mg twice daily); 20 kg or greater — 50 mg once daily (alternatively 25 mg twice daily). With integrase-class resistance: insufficient data to recommend a dose in adolescents or children.
Route: Oral (film-coated tablets)
Frequency: Once daily (or the label's alternative divided twice-daily doses, one morning and one evening)
These are the label's own printed figures (Table 1 and Table 2 for children; the adolescent paragraph), not scaled from the adult dose, and they apply to film-coated tablets only. The retrieved text does not state which tablet strengths make up the 40 mg and 20 mg doses. Dispersible tablets (for patients aged 4 weeks and above and weighing at least 3 kg, or where film-coated tablets are not appropriate) have their own dosing and are not interchangeable mg for mg; where possible children weighing 14 to less than 20 kg "should preferentially take the dispersible tablet formulation". Safety and efficacy in children aged less than 4 weeks or weighing less than 3 kg have not been established. Use a children's formulary for any figure not printed here.

Dose adjustments

Renal

SPC §4.2: "No dosage adjustment is required in patients with mild, moderate or severe (CrCl <30 mL/min, not on dialysis) renal impairment. No data are available in subjects receiving dialysis although differences in pharmacokinetics are not expected in this population" (see section 5.2). §4.4: dolutegravir increases metformin concentrations; metformin is eliminated renally, so renal function should be monitored, and the combination may increase the risk of lactic acidosis in moderate renal impairment (CrCl 45-59 mL/min) where a cautious approach and a reduced metformin dose are advised. §4.8: serum creatinine increases within the first week of treatment (mean 9.96 μmol/L at 48 weeks) are "not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate".

Hepatic

SPC §4.2: "No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh grade A or B). No data are available in patients with severe hepatic impairment (Child-Pugh grade C); therefore dolutegravir should be used with caution in these patients" (see section 5.2).

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (§4.3).
  • Medicinal products with narrow therapeutic windows that are substrates of organic cation transporter 2 (OCT2), including but not limited to fampridine (also known as dalfampridine) (§4.3).
  • Hypersensitivity reaction on dolutegravir (rash, constitutional findings, sometimes organ dysfunction including severe liver reactions): discontinue dolutegravir and other suspect medicinal products immediately (§4.4, a warning rather than a §4.3 contraindication).

Side effects

  • Very common: headache, nausea, diarrhoea (§4.8).
  • Common: insomnia, abnormal dreams, depression, anxiety, dizziness, vomiting, flatulence, upper abdominal pain, abdominal pain, abdominal discomfort, ALT and/or AST elevations, rash, pruritus, fatigue, creatine phosphokinase (CPK) elevations, weight increased (§4.8).
  • Uncommon: hypersensitivity, immune reconstitution syndrome, panic attack, suicidal ideation and suicide attempt (particularly in patients with a pre-existing history of depression or psychiatric illness), hepatitis, arthralgia, myalgia (§4.8).
  • Rare: completed suicide (particularly in patients with a pre-existing history of depression or psychiatric illness), acute hepatic failure, increased bilirubin (in combination with increased transaminases) (§4.8).
  • Very rare: sideroblastic anaemia (§4.8).
  • The most severe reaction seen in an individual patient was a hypersensitivity reaction that included rash and severe liver effects (§4.8).
  • Serum creatinine rises within the first week of treatment and remains stable; not considered clinically relevant (§4.8).
  • §4.8 is truncated at the source-fetch limit (the description of selected adverse reactions after the hepatitis B/C co-infection heading was not retrieved).

Interactions

  • Fampridine (dalfampridine) and other narrow-therapeutic-window OCT2 substrates: contraindicated (§4.3).
  • Efavirenz, nevirapine, tipranavir/ritonavir, rifampicin: dolutegravir should be administered twice daily (§4.2).
  • Medicinal products that reduce dolutegravir exposure — magnesium/aluminium-containing antacids, iron and calcium supplements, multivitamins, inducing agents, etravirine (without boosted protease inhibitors), tipranavir/ritonavir, rifampicin, St. John's wort and certain anti-epileptic medicinal products — should be avoided in the presence of integrase class resistance (§4.4).
  • Calcium, iron or magnesium supplements and multivitamins: with food they can be taken at the same time; under fasting conditions take them 2 hours after or 6 hours before Tivicay (§4.4).
  • Metformin: dolutegravir increased metformin concentrations; consider a metformin dose adjustment when starting and stopping co-administration; monitor renal function (§4.4).
  • The §4.5 interaction section was not retrieved (the fetched block is cut off at its heading).

Monitoring

  • Liver biochemistries in patients with hepatitis B and/or C co-infection; particular diligence in initiating or maintaining effective hepatitis B therapy when starting dolutegravir (§4.4).
  • If a hypersensitivity reaction is suspected: monitor clinical status including liver aminotransferases and bilirubin (§4.4).
  • Renal function when co-treated with metformin (§4.4).
  • Weight and blood lipids and glucose per established HIV treatment guidelines (§4.4).
  • Inflammatory symptoms of immune reactivation in the first weeks or months of combination antiretroviral therapy should be evaluated (§4.4).
  • Patients should remain under close clinical observation by physicians experienced in HIV disease (§4.4).

Clinical monograph

How it works

It inhibits HIV integrase, preventing integration of viral DNA into the host cell genome and thereby blocking viral replication.

Prescribing in practice

  • Follow current MHRA and specialist advice on use around conception and in pregnancy, as a possible signal of neural tube defects with early exposure has been kept under review; weigh the benefits of effective HIV control accordingly.
  • Dolutegravir can raise serum creatinine by inhibiting its tubular secretion without reducing true renal function.
  • Absorption is reduced by polyvalent cation-containing products, so separate dosing from antacids, and iron or calcium supplements.

Monitoring

Monitor HIV viral load and CD4 count to confirm response, with liver function checks particularly in those with hepatitis co-infection.

Counselling the patient

  • Take indigestion remedies, or iron and calcium supplements, well apart from your dose to avoid reducing its absorption.
  • If you could become pregnant or are planning pregnancy, discuss this with your HIV team.
  • Take the medicine consistently every day to keep the virus suppressed.

Evidence & guidelines

Dolutegravir-based regimens are recommended in UK and international HIV guidelines, supported by large randomised controlled trials.

Reference: SmPC Tivicay / Triumeq / Dovato; BHIVA Adult HIV Guidelines 2022; EACS Guidelines 12.0 (2024); WHO Consolidated ART Guidelines 2021; Tsepamo NEJM 2019; 381:827; SINGLE / SPRING-2 / FLAMINGO trials; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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