Alternate Name(s):
DTG, Tivicay®
Classification:
Integrase (Strand Transfer) Inhibitor (INSTI), Antiretroviral Agent
Original Date:
Sept 2026
Indications:
- HIV treatment: in combination with other antiretroviral agents for term infants (≥37 weeks gestation) [or preterm infants with a postmenstrual age ≥37 weeks at the time of treatment initiation] weighing ≥2 kg
- HIV prophylaxis: as alternative to nevirapine as recommended by Infectious Disease Specialist
Administration:
PO Soluble tablets: may be administered dispersed in water as an oral suspension.
- Add the tablet to ~ 5 mL water in a medication cup, and swirl the suspension gently for 1 to 2 minutes so that no lumps remain (will have cloudy appearance); draw up and administer using an oral syringe. To ensure the full dose is received, add another ~5 mL of water to the cup, swirl, and pull up remaining liquid into the oral syringe. Administer within 30 minutes of mixing.
- May be administered without regard to feeds
-
Cation-containing medications (such as calcium, iron, magnesium, zinc) and buffered medications may decrease concentrations of dolutegravir.
However, they may be given at the same time as dolutegravir safely if ingested with a meal. On an empty stomach, dolutegravir must be given 2 hours before or 6 hours after these minerals
Dosage:
| PNA | Weight | Dose |
| Birth to <14 days of age |
> 2 kg |
5 mg PO every other day |
| > 14 days of age to <4 weeks | > 2 kg | 5 mg PO once daily |
| > 4 weeks of age | > 2 kg to <6 kg | 5 mg PO once daily |
| > 6 kg to <10 kg | 15 mg PO once daily |
Side Effects:
- GI/GU: diarrhea, nausea, vomiting, gassiness, increases in LFT and bilirubin, hepatotoxicity
- CVS: fever
- CNS: insomnia, headache
- Derm: rash, pruritus; rare hypersensitivity reactions
- MSK: joint/muscle pain
Parameters to Monitor:
- Management of HIV infection requires extensive monitoring; refer to current clinical guidelines and experts for guidance
- Dolutegravir-specific recommendations:
- LFTs, creatinine, bilirubin
- Monitor for signs of hypersensitivity or immune reactions (e.g. IRIS or DRESS)
Notes:
- Dolutegravir decreases tubular secretion of creatinine and increases measured serum creatinine, without necessarily affecting glomerular filtration.
- Dolutegravir is a substrate for UGT1A1 and CYP3A; as well as UGT1A3, UGT1A9, breast cancer resistance protein, and P-glycoprotein in vitro. Drugs that induce these enzymes and transporters may decrease plasma concentrations of dolutegravir.; drugs that inhibit these enzymes or transporters may increase plasma concentrations
References:
- Bekker A, Salvadori N, Rabie H, du Toit S, Than-In-At K, Groenewald M, Barnabas S, Ganger L, Luangcharoenkul T, Pingkarawat S, Capparelli EV, Owen A, Cressey R, Fry S, Le Roux G, Tawon Y, Kaewmalee J, Phitak T, Lallemant M, Cotton MF, Cressey TR. Safety and pharmacokinetics of dolutegravir dispersible tablets and oral films in term neonates exposed to HIV in South Africa (PETITE-DTG study): an open-label, randomised, phase 1/2 trial. Lancet HIV. 2025 Nov;12(11):e753-e762.
- WHO updated recommendations on HIV clinical management: recommendations for a public health approach. World Health Organization 2025
-
Antiretroviral Management of Infants with In Utero, Intrapartum or Breastfeeding Exposure to HIV. National Institutes of Health- HIV.gov. June 2026
- PrTIVICAY Product Monograph
- Lexi-Drugs Online Database
- https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/dolutegravir