abacavir sulfate, dolutegravir sodium, lamivudine
abacavir sulfate, dolutegravir sodium, lamivudine is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Triumeq, Triumeq PD. Available dosage forms: tablet, film coated, kit.
Drug Details
- Generic Name
- abacavir sulfate, dolutegravir sodium, lamivudine
- Brand Names
- Triumeq, Triumeq PD
- Application Number
- NDA205551
- Sponsor
- ViiV Healthcare Company
- NDC Codes
- 2
- Dosage Forms
- TABLET, FILM COATED, KIT
- 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 )