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FULL PRESCRIBING INFORMATION
WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) ANDHUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINERESISTANTHBV AND EXACERBATIONS OF HBV
All patients with HIV-1 should be tested for the presence of HBV prior to or wheninitiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with
lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used inpatients co-infected with HIV-1 and HBV, additional treatment should be considered forappropriate treatment of chronic HBV; otherwise, consider an alternative regimen.
Severe acute exacerbations of HBV have been reported in patients who are co-infected withHIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closelymonitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment
[see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
DOVATO is indicated as a complete regimen for the treatment of human immunodeficiencyvirus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with noknown substitutions associated with resistance to the individual components of DOVATO.
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to or When Initiating Treatment with DOVATO
Prior to or when initiating DOVATO, test patients for HBV infection [see Warnings andPrecautions (5.1)].
Perform pregnancy testing before initiation of DOVATO in individuals of childbearing potential[see Warnings and Precautions (5.4), Use in Specific Populations (8.1, 8.3)].
2.2 Recommended Dosage
DOVATO is a fixed-dose combination product containing 50 mg of dolutegravir and 300 mg oflamivudine. The recommended dosage regimen of DOVATO in adults is one tablet taken orallyonce daily with or without food [see Clinical Pharmacology (12.3)].
2.3 Recommended Dosage with Certain Coadministered Drugs
The dolutegravir dose (50 mg) in DOVATO is insufficient when coadministered with drugslisted in Table 1 that may decrease dolutegravir concentrations; the following dolutegravirdosage regimen is recommended.
Table 1. Dosing Recommendations for DOVATO with Coadministered DrugsCoadministered Drug Dosing RecommendationCarbamazepine, rifampin An additional dolutegravir 50-mg tablet,separated by 12 hours from DOVATO,should be taken.
2.4 Not Recommended in Patients with Renal Impairment
Because DOVATO is a fixed-dose tablet and cannot be dose adjusted, DOVATO is notrecommended in patients with creatinine clearance less than 50 mL per minute [see Use inSpecific Populations (8.6)].
2.5 Not Recommended in Patients with Severe Hepatic Impairment
DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C)[see Use in Specific Populations (8.7)].
3 DOSAGE FORMS AND STRENGTHS
DOVATO tablets are