Indications for: TRIUMEQ PD
HIV-1 infection in patients aged ≥3 months and weighing ≥6kg.
Limitations of Use:
Not recommended alone in patients with resistance-associated integrase substitutions or suspected INSTI resistance due to insufficient dolutegravir dose in Triumeq and Triumeq PD in these subpopulations.
<3mos or <6kg: not established. Fully disperse the tabs for oral susp in 20mL of drinking water. After dispersion, administer susp within 30mins of mixing. 6–<10kg: 3 tabs once daily (180mg/15mg/90mg total dose); 10–<14kg: 4 tabs once daily (240mg/20mg/120mg total dose); 14–<20kg: 5 tabs once daily (300mg/25mg/150mg total dose); 20–<25kg: 6 tabs once daily (360mg/30mg/180mg total dose); ≥25kg: not recommended (use Triumeq tabs only). Concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, rifampin (6–<10kg): give additional dolutegravir 15mg in 12hrs after Triumeq PD; (10–<14kg): give additional dolutegravir 20mg in 12hrs after Triumeq PD; (14–<20kg): give additional dolutegravir 25mg in 12hrs after Triumeq PD; (20–<25kg): give additional dolutegravir 30mg in 12hrs after Triumeq PD.
TRIUMEQ PD Contraindications:
Presence of HLA-B*5701 allele. Previous hypersensitivity reaction to any of the components. Concomitant dofetilide. Moderate or severe hepatic impairment.
Hypersensitivity reactions. Exacerbation of hepatitis B.
TRIUMEQ PD Warnings/Precautions:
Tabs and tabs for oral susp are not interchangeable on a mg per mg basis. Screen for presence of HLA-B*5701 allele prior to starting therapy or reinitiation; if (+), abacavir is contraindicated. Discontinue immediately if hypersensitivity is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible. If hypersensitivity cannot be ruled out, do not restart. If stopped for reasons other than hypersensitivity, restart only if medical care can be readily accessed. Test for the presence of HBV infection in all patients prior to or when initiating therapy. Lamivudine not established for chronic HBV infection; if treatment is initiated in patients co-infected with HIV and HBV, additional treatment should be considered for chronic HBV (if not, use alternative regimen). Monitor closely for severe acute exacerbations of HBV in patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, initiate anti-hepatitis B therapy may be warranted. Increased risk for worsening/development of elevated transaminases in patients with underlying hepatitis B or C; monitor for hepatotoxicity. Suspend if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Underlying risk of coronary heart disease (eg, hypertension, hyperlipidemia, diabetes, smoking). Renal impairment (CrCl <30mL/min): not recommended; if lamivudine dose reduction is required, use individual components; (CrCl 30–49mL/min): monitor for hematologic toxicities; if new or worsening neutropenia or anemia develop, adjust lamivudine dose. Mild hepatic impairment: not recommended; if abacavir dose reduction is required, use individual components. Women. Obesity. Elderly. Embryo-fetal toxicity: increased risk of neural tube defects (assess risks/benefits; consider alternative treatment at time of conception through 1st trimester or if pregnancy is confirmed). Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception. Nursing mothers: not recommended.
TRIUMEQ PD Classification:
Nucleoside reverse transcriptase inhibitors (NRTIs) + integrase strand transfer inhibitor (INSTI).
TRIUMEQ PD Interactions:
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, St. John’s wort. 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 and Children). May potentiate drugs eliminated via OCT2 or MATE1 (eg, dofetilide, dalfampridine, metformin). Avoid concomitant sorbitol-containing products. Concomitant cation-containing antacids, laxatives, sucralfate, buffered drugs, or oral iron/calcium supplements (also can give together with a meal): give Triumeq or Triumeq PD 2hrs before or 6hrs after. Ethanol may increase abacavir levels. Abacavir may antagonize methadone. Potentiates riociguat; may need to reduce riociguat dose.
Insomnia, headache, fatigue; hypersensitivity reactions (may be fatal), hepatotoxicity, immune reconstitution syndrome.
Abacavir: alcohol dehydrogenase, glucuronyl transferase. Dolutegravir: UGT1A1 (primarily), CYP3A.
Renal. Half-life: 1.54 ± 0.63 hours (abacavir); ~14 hours (dolutegravir); 13–19 hours (lamivudine). Total clearance: 0.80 ± 0.24 L/h/kg (abacavir); 1.0 L/h (dolutegravir); 398.5 ± 69.1 mL per min (lamivudine).
Generic Drug Availability:
Tabs—30; PD—90 (w. dosing cup)