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:

Previous hypersensitivity reaction to dolutegravir or lamivudine. 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. Immune reconstitution syndrome. Renal impairment (see Adults); if lamivudine dose reduction is required, use individual components. Severe hepatic impairment (see Adults). Women. Obesity. 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, switch to alternative HIV therapy. 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: requires extra dolutegravir dose (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 (may be fatal), hepatotoxicity (monitor).

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

Pricing for DOVATO

50mg/300mg tablet (Qty: 30)
Appx. price $2280
GoodRx