Medically reviewed by Drugs.com. Last updated on Jan 20, 2022.
Generic name: DOLUTEGRAVIR SODIUM 50mg, LAMIVUDINE 300mg
Dosage form: tablet, film coated
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)].
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.
An additional dolutegravir 50-mg tablet, separated by 12 hours from DOVATO, should be taken.
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)].
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