Dovato Generic Name & Formulations
Dolutegravir 50mg, lamivudine 300mg; tabs.
HIV-1 integrase strand transfer inhibitor (INSTI) + nucleoside analog reverse transcriptase inhibitors (NRTIs).
As a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.
Dovato Dosage and Administration
Test for HBV infection prior to initiation. Take with or without food. 1 tab daily. Concomitant carbamazepine, rifampin: give additional dolutegravir 50mg separated by 12hrs from Dovato. Renal impairment (CrCl <30mL/min) or severe hepatic impairment (Child-Pugh C): not recommended.
Dovato Boxed Warnings
Patients co-infected with HBV and HIV-1: Emergence of lamivudine-resistant HBV and exacerbations of HBV.
Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens. Discontinuation of lamivudine-containing products and possibly Dovato may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in advanced liver disease or cirrhosis). Discontinue immediately if hypersensitivity reactions develop. 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. Renal impairment (CrCl <30mL/min): if lamivudine dose reduction is required, use individual components; (CrCl 30–49mL/min): monitor for hematologic toxicities; may need dose adjustment. Severe hepatic impairment (see Adult dose). Elderly. Embryo-fetal toxicity: increased risk of neural tube defects (consider alternative treatment at time of conception through 1st trimester or if pregnancy is confirmed). Pregnancy: exclude status prior to initiation. Advise individuals of reproductive potential to use effective contraception. Nursing mothers: not recommended.
Median time to maximum concentration: 2.5 hours (dolutegravir); 1 hour (lamivudine).
Plasma protein binding: ~99% (dolutegravir); 36% (lamivudine).
Dolutegravir: UGT1A1 (primary), CYP3A4 (minor). Lamivudine: not significantly metabolized.
Dolutegravir: renal (31%), fecal (64%). Lamivudine: renal (~70%). Half-life: ~14 hours (dolutegravir); 13–19hrs (lamivudine).
See Contraindications. Concomitant other antiretrovirals: not recommended. Dolutegravir may be affected by drugs that induce or inhibit UGT1A1, CYP3A, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. May potentiate drugs eliminated via OCT2 or MATE1 (eg, dofetilide, dalfampridine, metformin). Avoid concomitant oxcarbazepine, phenytoin, phenobarbital, St. John’s wort. Antagonized by carbamazepine, rifampin; see Adults. 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 Dovato 2hrs before or 6hrs after.
Dovato Adverse Reactions
Headache, nausea, diarrhea, insomnia, fatigue, anxiety; hypersensitivity reactions, hepatotoxicity, immune reconstitution syndrome.
Dovato Clinical Trials
To enroll pregnant patients exposed to Dovato in the Antiretroviral Pregnancy Registry (APR), call (800) 258-4263.
Dovato Patient Counseling