Dolutegravir Sodium (7 brand names, 2 dosage forms, 2 routes)
Available dosage forms: TABLET, TABLET, FOR SUSPENSION.
Routes of administration: ORAL, ORAL SUSPENSION.
Brand Names
- DOLUTEGRAVIR SODIUM
- DOVATO
- JULUCA
- TIVICAY
- TIVICAY PD
- TRIUMEQ
- TRIUMEQ PD
Related Health Topics
Indications and Usage
TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of 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 [see Microbiology ( 12.4)]. TIVICAY 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/ 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.
Contraindications
TIVICAY and TIVICAY PD are contraindicated in patients: with previous hypersensitivity reaction to dolutegravir [see Warnings and Precautions ( 5.1)]. receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see Drug Interactions ( 7)] .
Adverse Reactions
The following serious adverse drug reactions are discussed in other sections of the labeling: Hypersensitivity reactions [see Warnings and Precautions ( 5.1)] . Hepatotoxicity [see Warnings and Precautions ( 5.2)]. Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.4)] .
Mechanism of Action
Dolutegravir is an HIV-1 antiretroviral agent [see Microbiology ( 12.4)].
Overdosage
There is no known specific treatment for overdose with TIVICAY or TIVICAY PD. If overdose occurs, the patient should be monitored, and standard supportive treatment applied as required. As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.