Generic Name and Formulations:
Abacavir 600mg, dolutegravir 50mg, lamivudine 300mg; tabs.

Company:
ViiV Healthcare
Indications for TRIUMEQ:
HIV-1 infection.

Limitations Of use:
Not recommended alone in patients with current or history of resistance to any of the components; or alone in resistance-associated integrase substitutions or INSTI resistance due to insufficient dolutegravir dose in Triumeq in these subpopulations.

Adult:
1 tab daily. Concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, rifampin: give additional dolutegravir 50mg separated by 12hrs from Triumeq.

Children:
Not established.

Contraindications:
Presence of HLA-B*5701 allele. Previous hypersensitivity reaction to any of the components. Concomitant dofetilide. Moderate or severe hepatic impairment.

Warnings/Precautions:
See full labeling re: fatal hypersensitivity reactions with abacavir; discontinue as soon as suspected; do not restart. eva luate for presence of HLA-B*5701 allele prior to starting therapy or reinitiation; if (+), abacavir is contraindicated; discontinue permanently if hypersensitivity cannot be ruled out even if other diagnoses are possible, regardless of HLA-B*5701 status. If stopped for reasons other than hypersensitivity, restart only if medical care can be readily accessed; monitor. Suspend if lactic acidosis or hepatotoxicity occurs. Increased risk for worsening/development of elevated transaminases in patients with hepatitis B or C; monitor LFTs prior to starting, during therapy, and for at least several months after stopping treatment (discontinuing may exacerbate HBV infection). Myocardial infarction: consider CHD risk before starting therapy and minimize modifiable risk factors (eg, HTN). Renal impairment (CrCl <50mL/min): not recommended. Mild hepatic impairment: use individual components if lamivudine or abacavir dose reductions are required. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Concomitant other abacavir- or lamivudine-containing products: not recommended. Ethanol may increase abacavir levels. Abacavir may increase clearance of methadone. Dolutegravir may be affected by drugs that induce or inhibit UGT1A1, CYP3A, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. Avoid concomitant nevirapine, oxcarbazepine, phenytoin, phenobarbital, carbamazepine, St. John’s wort. Potentiates metformin (limit metformin dose to 1g/day). Concomitant etravirine without atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir: not recommended. Concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, rifampin: requires extra dolutegravir dose (see Adults). Concomitant cation-containing antacids or laxatives, sucralfate, buffered drugs, oral calcium/iron supplements, multivitamins; give Triumeq 2hrs before or 6hrs after; alternatively, oral calcium/iron can be used at the same time when taken with food. Monitor for toxicities (eg, hepatic decompensation) with IFN-α ± ribavirin (consider reducing dose or discontinue one or both drugs).

Pharmacological Class:
Nucleoside reverse transcriptase inhibitors (NRTIs) + integrase strand transfer inhibitor (INSTI).

Adverse Reactions:
Insomnia, headache, fatigue; immune reconstitution syndrome, fat redistribution; serious: hypersensitivity reactions, lactic acidosis, hepatotoxicity.

Generic Availability:
NO

How Supplied:
Tabs—30