INDICATIONS AND USAGE

Dolutegravir indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg.

Dolutegravir is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.

DOSAGE

Recommended Dosage in Adults

Dolutegravir tablets may be taken with or without food. The recommended dosage is:

Treatment-naïve or treatment-experienced INSTI-naïve or virologically suppressed (HIV-1 RNA <50 copies per mL) adults switching to dolutegravir plus rilpivirine: 50 mg once daily

Treatment-naïve or treatment-experienced INSTI-naïve when coadministered with certain uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A) or cytochrome P450 (CYP)3A inducers: 50 mg twice daily

INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50 mg twice daily

Recommended Dosage in Pediatric Patients Weighing 3 to 14 kg

The recommended weight-based dosage of Dolutegravir PD tablets for oral suspension in pediatric patients weighing 3 to 14 kg (4 weeks and older, treatment-naïve or treatment-experienced but naïve to INSTI treatment) is:

3 kg to less than 6 kg: 5 mg once daily

6 kg to less than 10 kg: 15 mg once daily

10 kg to less than 14 kg: 20 mg once daily

Recommended Dosage in Pediatric Patients Weighing 14 kg or Greater

For pediatric patients weighing 14 kg or greater (4 weeks and older, treatment-naïve or treatment-experienced but naïve to INSTI treatment) administer either:

Dolutegravir PD tablets for oral suspension (preferred in pediatric patients weighing less than 20 kg) (Table 3), or

Dolutegravir tablets for oral use.

ADVERSE REACTIONS

Hypersensitivity reactions

Hepatotoxicity

Immune Reconstitution Syndrome

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/63df5af3-b8ac-4e76-9830-2dbb340af922/spl-doc?hl=Tivicay

Instgrainformation