Viral infections:
Indications for DOVATO:
As a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components of Dovato.
Adult:
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 <50mL/min) or severe hepatic impairment (Child-Pugh C): not recommended.
Children:
Not established.
Contraindications:
Concomitant dofetilide.
Boxed Warning:
Patients co-infected with HBV and HIV-1: Emergence of lamivudine-resistant HBV and exacerbations of HBV.
Warnings/Precautions:
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 (see Adults); if lamivudine dose reduction is required, use individual components. Severe hepatic impairment (see Adults). Elderly. Embryo-fetal toxicity: increased risk of neural tube defects (avoid use at time of conception through 1st trimester). Pregnancy: exclude status prior to initiation; if confirmed in 1st trimester, consider switching to alternative HIV regimen. Advise females of reproductive potential to use effective contraception. Nursing mothers: not recommended.
Pharmacologic Class:
HIV-1 integrase strand transfer inhibitor (INSTI) + nucleoside analog reverse transcriptase inhibitors (NRTIs).
Interactions:
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. Avoid concomitant oxcarbazepine, phenytoin, phenobarbital, St. John’s wort. Antagonized by carbamazepine, rifampin; see Adults. Potentiates 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 Dovato 2hrs before or 6hrs after.
Adverse Reactions:
Headache, diarrhea, nausea, insomnia, fatigue, dizziness; hypersensitivity reactions, hepatotoxicity, immune reconstitution syndrome.
Note:
To enroll pregnant patients exposed to Dovato in the Antiretroviral Pregnancy Registry (APR), call (800) 258-4263.
Generic Availability:
NO
How Supplied:
Tabs—30
