Testing Prior to or When Initiating Treatment with DOVATO

Prior to or when initiating DOVATO, test patients for HBV infection [see Warnings and Precautions (5.1)].

Pregnancy testing is recommended before initiation of DOVATO in individuals of childbearing potential [see Warnings and Precautions (5.4), Use in Specific Populations (8.1, 8.3)].

Recommended Dosage

DOVATO is a fixed-dose combination product containing 50 mg of dolutegravir and 300 mg of lamivudine. The recommended dosage regimen of DOVATO in adults is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3)].

Recommended Dosage with Certain Coadministered Drugs

The dolutegravir dose (50 mg) in DOVATO is insufficient when coadministered with drugs listed in Table 1 that may decrease dolutegravir concentrations; the following dolutegravir dosage regimen is recommended.

Not Recommended in Patients with Renal Impairment

Because DOVATO is a fixed-dose tablet and cannot be dose adjusted, DOVATO is not recommended in patients with creatinine clearance less than 30 mL per minute [see Use in Specific Populations (8.6)].

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)].