Abacavir, Dolutegravir and Lamivudine

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.

TRIUMEQ and TRIUMEQ PD are a fixed-dose combination of the HIV‑1 antiretroviral agents abacavir, dolutegravir, and lamivudine.

• Before initiating TRIUMEQ or TRIUMEQ PD, screen for the HLA‑B*5701 allele because TRIUMEQ and TRIUMEQ PD contain abacavir. • Prior to or when initiating TRIUMEQ or TRIUMEQ PD, test patients for HBV infection. • TRIUMEQ and TRIUMEQ PD may be taken with or without food. • Adults: One tablet of TRIUMEQ daily. ABC = abacavir, DTG = dolutegravir, 3TC = lamivudine. Pediatric Population Body Weight Number of Tablets (once daily) Recommended Daily Dose TRIUMEQ PD Tablets (6 kg to <25 kg) 6 kg to <10 kg 3 180 mg ABC, 15 mg DTG, and 90 mg 3TC 10 kg to <14 kg 4 240 mg ABC, 20 mg DTG, and 120 mg 3TC 14 kg to <20 kg 5 300 mg ABC, 25 mg DTG, and 150 mg 3TC 20 kg to <25 kg 6 360 mg ABC, 30 mg DTG, and 180 mg 3TC TRIUMEQ Tablets (≥25 kg) ≥25 kg 1 600 mg ABC, 50 mg DTG, and 300 mg 3TC • Do not substitute TRIUMEQ and TRIUMEQ PD on a milligram-per-milligram basis.

TRIUMEQ and TRIUMEQ PD are contraindicated in patients: • who have the HLA-B*5701 allele. • with prior hypersensitivity reaction to abacavir, dolutegravir, or lamivudine. • receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events with concomitant use of dolutegravir. • with moderate or severe hepatic impairment. • Presence of HLA-B*5701 allele. • Prior hypersensitivity reaction to abacavir, dolutegravir, or lamivudine. • Coadministration with dofetilide. • Moderate or severe hepatic impairment.

Boxed warning (hypersensitivity reactions, and exacerbations of hepatitis b): Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of TRIUMEQ and TRIUMEQ PD (abacavir, dolutegravir, and lamivudine). • Hepatotoxicity has been reported in patients receiving a dolutegravir-containing regimen. Monitoring for hepatotoxicity is recommended. • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. • TRIUMEQ tablets and TRIUMEQ PD tablets for oral suspension are not substitutable.

The following adverse reactions are discussed in other sections of the labeling: • Serious and sometimes fatal hypersensitivity reaction. • Exacerbations of hepatitis B. • Hepatotoxicity. • Lactic acidosis and severe hepatomegaly with steatosis. • Immune reconstitution syndrome. • Myocardial infarction. The most commonly reported adverse reactions of at least moderate intensity and incidence at least 2% (in those receiving TRIUMEQ) were insomnia, headache, and fatigue.

Coadministration of TRIUMEQ or TRIUMEQ PD with other drugs can alter the concentration of other drugs and other drugs may alter the concentrations of TRIUMEQ or TRIUMEQ PD. The potential drug-drug interactions must be considered prior to and during therapy.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F). Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed.