Viral infections:
Indications for DOVATO:
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.
Adult Dosage:
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.
Children Dosage:
Not established.
DOVATO Contraindications:
Concomitant dofetilide.
Boxed Warning:
Patients co-infected with HBV and HIV-1: Emergence of lamivudine-resistant HBV and exacerbations of HBV.
DOVATO 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 (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 (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 individuals of reproductive potential to use effective contraception. Nursing mothers: not recommended.
DOVATO Classification:
HIV-1 integrase strand transfer inhibitor (INSTI) + nucleoside analog reverse transcriptase inhibitors (NRTIs).
DOVATO 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 (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.
Adverse Reactions:
Headache, nausea, diarrhea, insomnia, fatigue, anxiety; 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 Drug Availability:
NO
How Supplied:
Tabs—30
