dolutegravir sodium

FDA Drug Profile — Tivicay, Tivicay PD

Drug Details

Generic Name
dolutegravir sodium
Brand Names
Tivicay, Tivicay PD
Application Number
NDA204790
Sponsor
Glaxo Operations UK Ltd
NDC Codes
10
Dosage Forms
TABLET, FILM COATED, TABLET, FOR SUSPENSION, POWDER
Routes
ORAL
Active Ingredients
DOLUTEGRAVIR SODIUM

Indications and Usage

1 INDICATIONS AND USAGE DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or 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 with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO. DOVATO, a two-drug combination of dolutegravir (integrase strand transfer inhibitor [INSTI]) and lamivudine (nucleoside analogue reverse transcriptase inhibitor [NRTI]) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or 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 with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO. ( 1 )