Abacavir/Dolutegravir/Lamivudine (4 brand names, 1 dosage form, 0 routes)
Available dosage forms: TABLET.
Brand Names
- ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE
- ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE
- ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE
- DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE
Boxed Warning
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). Patients who carry the HLA‑B5701 allele are at a higher risk of a hypersensitivity reaction to abacavir, although hypersensitivity reactions have occurred in patients who do not carry the HLA‑B5701 allele [see Warnings and Precautions (5.1)]. TRIUMEQ and TRIUMEQ PD are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA‑B5701-positive patients [see Contraindications (4), Warnings and Precautions (5.1)]. All patients should be screened for the HLA‑B5701 allele prior to initiating therapy with TRIUMEQ or TRIUMEQ PD or reinitiation of therapy with TRIUMEQ or TRIUMEQ PD, unless patients have a previously documented HLA‑B5701 allele assessment. Discontinue TRIUMEQ or TRIUMEQ PD immediately if a hypersensitivity reaction is suspected, regardless of HLA‑B5701 status and even when other diagnoses are possible [see Contraindications (4), Warnings and Precautions (5.1)]. Following a hypersensitivity reaction to TRIUMEQ or TRIUMEQ PD, NEVER restart TRIUMEQ or TRIUMEQ PD or any other abacavir‑containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity [see Warnings and Precautions (5.1)]. Exacerbations of Hepatitis B All patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) prior to or when initiating TRIUMEQ or TRIUMEQ PD. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If TRIUMEQ or TRIUMEQ PD is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatme
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).
Contraindications
TRIUMEQ and TRIUMEQ PD are contraindicated in patients: •who have the HLA-B*5701 allele [see Warnings and Precautions (5.1)]. •with prior hypersensitivity reaction to abacavir, dolutegravir [see Warnings and Precautions (5.1)], 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 [see Drug Interactions (7)]. •with moderate or severe hepatic impairment [see Use in Specific Populations (8.7)].
Adverse Reactions
The following adverse reactions are discussed in other sections of the labeling: •Serious and sometimes fatal hypersensitivity reaction [see Boxed Warning, Warnings and Precautions (5.1)]. •Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions (5.3)]. •Hepatotoxicity [see Warnings and Precautions (5.3)]. •Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.4)]. •Immune reconstitution syndrome [see Warnings and Precautions (5.6)]. •Myocardial infarction [see Warnings and Precautions (5.8)].
Mechanism of Action
TRIUMEQ and TRIUMEQ PD are a fixed-dose combination of the HIV‑1 antiretroviral agents abacavir, dolutegravir, and lamivudine [see Microbiology (12.4)].
Overdosage
There is no known specific treatment for overdose with TRIUMEQ or TRIUMEQ PD. If overdose occurs, the patient should be monitored, and standard supportive treatment applied as required. Dolutegravir As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis. Abacavir It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis. Lamivudine Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.