HIV Infection
Dovato (dolutegravir and lamivudine) is a once-daily, single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and lamivudine (Epivir) indicated for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either dolutegravir or lamivudine. Each DOVATO tablet contains 50 mg of dolutegravir as dolutegravir sodium and 300 mg lamivudine and is an oval, biconvex, white, film-coated tablet, debossed with "SV 137" on one face.
Bottle of 30 tablets with child-resistant closure NDC 49702-246-13.
Store below 30�C (86�F). These highlights do not include all the information needed to use DOVATO safely and effectively. See full prescribing information for DOVATO.
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 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.
Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity (5.4)
10/2019
INDICATIONS AND USAGE
DOVATO, a two-drug combination of dolutegravir (integrase strand transfer inhibitor [INSTI]) and lamivudine (nucleoside analogue reverse transcriptase inhibitor [NRTI]) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components of DOVATO. (1)
DOSAGE AND ADMINISTRATION
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Prior to or when initiating DOVATO, test patients for HBV infection. (2.1)
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Pregnancy Testing: Perform pregnancy testing before initiation of DOVATO in individuals of childbearing potential. (2.1, 5.4)
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One tablet taken orally once daily with or without food. (2.2)
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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. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg of dolutegravir and 300 mg of lamivudine. (3)
CONTRAINDICATIONS
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Prior hypersensitivity reaction to dolutegravir or lamivudine. (4)
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Coadministration with dofetilide. (4)
WARNINGS AND PRECAUTIONS
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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. (5.2)
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Hepatotoxicity has been reported in patients receiving a dolutegravir-containing regimen. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with DOVATO. Monitoring for hepatotoxicity is recommended. (5.3)
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Embryo-fetal toxicity may occur when used at the time of conception and in early pregnancy. An alternative treatment to DOVATO should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects. Counsel individuals of childbearing potential to use effective contraception. (2.1, 5.4, 8.1, 8.3)
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Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. (5.5)
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Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. (5.7)
ADVERSE REACTIONS
The most common adverse reactions (all grades) observed in ?2% (in those receiving DOVATO) were headache, diarrhea, nausea, insomnia, and fatigue. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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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. (7.1)
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Refer to the full prescribing information for important drug interactions with DOVATO. (4, 5.6, 7)
USE IN SPECIFIC POPULATIONS
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Pregnancy: An alternative treatment to DOVATO should be considered at the time of conception through the first trimester due to the risk of neural tube defects. (2.1, 5.4, 8.1)
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Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. (8.2)
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Females and males of reproductive potential: Pregnancy testing and contraception are recommended in individuals of childbearing potential. (8.3)
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Renal Impairment: DOVATO is not recommended in patients with creatinine clearance less than 50 mL/min. (8.6)
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Hepatic Impairment: DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C). (8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2019
