abacavir sulfate, dolutegravir sodium, lamivudine

FDA Drug Profile — Triumeq PD, Triumeq

Drug Details

Generic Name
abacavir sulfate, dolutegravir sodium, lamivudine
Brand Names
Triumeq PD, Triumeq
Application Number
NDA215413
Sponsor
ViiV Healthcare Company
NDC Codes
2
Dosage Forms
KIT, TABLET, FILM COATED
Routes
ORAL
Active Ingredients
ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE

Indications and Usage

1 INDICATIONS AND USAGE TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg. Limitations of Use: TRIUMEQ and TRIUMEQ PD alone are not recommended in patients with resistance‑associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (INSTI) resistance because the dose of dolutegravir in TRIUMEQ and TRIUMEQ PD is insufficient in these subpopulations. See full prescribing information for TIVICAY (dolutegravir). TRIUMEQ and TRIUMEQ PD are a combination of dolutegravir (integrase strand transfer inhibitor [INSTI]), abacavir, and lamivudine (both nucleoside analogue reverse transcriptase inhibitors) indicated for the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg. ( 1 ) Limitations of Use: TRIUMEQ and TRIUMEQ PD alone are not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in TRIUMEQ and TRIUMEQ PD is insufficient in these subpopulations. See the dolutegravir prescribing information. ( 1 )