Dolutegravir and Lamivudine

DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 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 is a fixed-dose combination of the HIV‑1 antiretroviral agents, dolutegravir and lamivudine.

• Prior to or when initiating DOVATO, test patients for hepatitis B virus (HBV) infection. • One tablet taken orally once daily with or without food. • The dolutegravir dose (50 mg) in DOVATO is insufficient when coadministered with carbamazepine or rifampin. If DOVATO is coadministered with carbamazepine or rifampin, take one tablet of DOVATO once daily, followed by an additional dolutegravir 50-mg tablet, approximately 12 hours from the dose of DOVATO.

DOVATO is contraindicated in patients: • with prior hypersensitivity reaction to dolutegravir or lamivudine. • receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events. • Prior hypersensitivity reaction to dolutegravir or lamivudine. • Coadministration with dofetilide.

Boxed warning: All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV, otherwise, consider an alternative regimen. • Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with dolutegravir. Discontinue DOVATO immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. • Hepatotoxicity has been reported in patients receiving a dolutegravir-containing regimen.

The following adverse reactions are discussed in other sections of the labeling: • Patients co-infected with HIV-1 and HBV • Hypersensitivity reactions • Hepatotoxicity • Lactic acidosis and severe hepatomegaly with steatosis • Immune reconstitution syndrome The most common adverse reactions (all grades) observed in ≥2% (in those receiving DOVATO) were headache, nausea, diarrhea, insomnia, fatigue, and anxiety.

• DOVATO is a complete regimen for the treatment of HIV-1 infection, therefore, coadministration with other antiretroviral drugs for the treatment of HIV-1 infection is not recommended. • Refer to the full prescribing information for important drug interactions with DOVATO.

Store below 30°C (86°F).