What is the generic name?

DOLUTEGRAVIR SODIUM

What is the Trade Name for DOLUTEGRAVIR SODIUM?

Tivicay

What are the Indications for DOLUTEGRAVIR SODIUM?

• 1 INDICATIONS AND USAGE TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‚Äë1) infection in adults (treatment-na√Øve or -experienced) and in pediatric patients (treatment-na√Øve or -experienced but integrase strand transfer inhibitor [INSTI]-na√Øve) 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 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. TIVICAY and TIVICAY PD are a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-na√Øve or -experienced) and in pediatric patients (treatment-na√Øve or -experienced but INSTI- na√Øve) aged at least 4 weeks and weighing at least 3 kg. ( 1 ) 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 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. ( 1 )

References: https://open.fda.gov/