Triumeq Pd

— THERAPEUTIC CATEGORIES —
  • Viral infections

Triumeq Pd Generic Name & Formulations

General Description

Abacavir 60mg, dolutegravir 5mg, lamivudine 30mg; tabs for oral susp; strawberry cream flavored.

Pharmacological Class

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

See Also

How Supplied

Tabs—30; PD—90 (w. dosing cup)

Manufacturer

Generic Availability

NO

Mechanism of Action

Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration which is essential for the HIV replication cycle. Abacavir is converted to the active metabolite, carbovir triphosphate, which inhibits the activity of HIV-1 reverse transcriptase both by competing with the natural substrate dGTP and by its incorporation into viral DNA. Lamivudine is converted to its active metabolite, lamivudine triphosphate, which inhibits reverse transcriptase via DNA chain termination after incorporation of the nucleotide analogue.

Triumeq Pd Indications

Indications

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.

Triumeq Pd Dosage and Administration

Adult

Not recommended.

Children

<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

Contraindications

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

Triumeq Pd Boxed Warnings

Boxed Warning

Hypersensitivity reactions. Exacerbation of hepatitis B.

Triumeq Pd Warnings/Precautions

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. Pregnancy. Nursing mothers: see full labeling for potential risks in infants.

Triumeq Pd Pharmacokinetics

Absorption

Peak plasma concentrations are reached at 2–3 hours postdose (dolutegravir). 

Distribution

Plasma protein bound: ~50% (abacavir); ≥98.9% (dolutegravir); low (lamivudine). Volume of distribution: 17.4 L (dolutegravir).

Metabolism

Abacavir: alcohol dehydrogenase, glucuronyl transferase. Dolutegravir: UGT1A1 (primarily), CYP3A.

Elimination

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).

 

Triumeq Pd Interactions

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.

Triumeq Pd Adverse Reactions

Adverse Reactions

Insomnia, headache, fatigue; hypersensitivity reactions (may be fatal), hepatotoxicity, immune reconstitution syndrome.

Triumeq Pd Clinical Trials

See Literature

Triumeq Pd Note

Not Applicable

Triumeq Pd Patient Counseling

See Literature