HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useDOVATO safely and effectively.
See full prescribing information forDOVATO.
DOVATO(dolutegravir and lamivudine)tablets, for oral use
Initial U.S. Approval: 2019
WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS(HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1):
EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND
EXACERBATIONS OF HBV
See full prescribing information for complete boxed warning.
All patients with HIV-1 should be tested for the presence of HBV prior toor when initiating DOVATO. Emergence of lamivudine-resistant HBVvariants associated with lamivudine-containing antiretroviral regimens hasbeen reported. If DOVATO is used in patients co-infected with HIV-1 andHBV, additional treatment should be considered for appropriate treatmentof chronic HBV; otherwise, consider an alternative regimen.
Severe acute exacerbations of HBV have been reported in patients who areco-infected with HIV-1 and HBV and have discontinued lamivudine, acomponent of DOVATO. Closely monitor hepatic function in these patientsand, if appropriate, initiate anti-HBV treatment. (5.1)
INDICATIONS AND USAGE
DOVATO, a two-drug combination of dolutegravir (integrase strand transferinhibitor [INSTI]) and lamivudine (nucleoside analogue reverse transcriptaseinhibitor [NRTI]) is indicated as a complete regimen for the treatment ofhuman immunodeficiency virus type 1 (HIV-1) infection in adults with noantiretroviral treatment history and with no known substitutions associatedwith resistance to the individual components of DOVATO. (1)
DOSAGE AND ADMINISTRATION
• Prior to or when initiating DOVATO, test patients for HBV infection.(2.1)
• Pregnancy Testing: Perform pregnancy testing before initiation ofDOVATO in individuals of childbearing potential. (2.1, 5.4)
• One tablet taken orally once daily with or without food. (2.2)
• The dolutegravir dose (50 mg) in DOVATO is insufficient whencoadministered with carbamazepine or rifampin. If DOVATO iscoadministered with carbamazepine or rifampin, take one tablet ofDOVATO once daily, followed by an additional dolutegravir 50-mgtablet, approximately 12 hours from the dose of DOVATO. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg of dolutegravir and 300 mg of lamivudine. (3)
 CONTRAINDICATIONS
• Prior hypersensitivity reaction to dolutegravir or lamivudine. (4)
• Coadministration with dofetilide. (4)
WARNINGS AND PRECAUTIONS
• Hypersensitivity reactions characterized by rash, constitutional findings,and sometimes organ dysfunction, including liver injury, have been reported with dolutegravir. Discontinue DOVATO immediately if signsor symptoms of hypersensitivity reactions develop, as a delay in stoppingtreatment may result in a life-threatening reaction. (5.2)
• Hepatotoxicity has been reported in patients receiving a dolutegravircontainingregimen. Patients with underlying hepatitis B or C may be atincreased risk for worsening or development of transaminase elevationswith DOVATO. Monitoring for hepatotoxicity is recommended. (5.3)
• Embryo-fetal toxicity may occur when used at the time of conception andin early pregnancy. Avoid use of DOVATO at the time of conceptionthrough the first trimester of pregnancy due to the risk of neural tubedefects. Advise in