Dovato Dosage/Direction for Use

Therapy should be initiated by a physician experienced in the management of HIV infection.
DOVATO can be taken with or without food.
DOVATO is a fixed-dose tablet and should not be prescribed for patients requiring dosage adjustments, such as those with creatinine clearance less than 30 mL/min.
A separate preparation of dolutegravir (TIVICAY) is available where a dose adjustment is required due to drug-drug interactions (See Interactions).
For patients with integrase inhibitor resistance DOVATO is not recommended. In this case the physician should refer to the TIVICAY product information.
Adults and Adolescents: The recommended dose of DOVATO in adults and adolescents weighing at least 40 kg is one tablet once daily.
Children: DOVATO is not currently recommended for the treatment of children less than 12 years of age as the necessary dose adjustment cannot be made. Clinical data is currently not available for this combination. Physicians should refer to the individual product information for dolutegravir and lamivudine.
Elderly: There are limited data available on the use of dolutegravir and lamivudine in patients aged 65 years and over. However, there is no evidence that elderly patients require a different dose than younger adult patients (see PHARMACOLOGY: Pharmacokinetics: Special patient populations under Actions). When treating elderly patients, consideration needs to be given to the greater frequency of decreased hepatic and renal function, haematological abnormalities, and concomitant medicinal products or disease.
Renal impairment: Whilst no dosage adjustment of dolutegravir is necessary in patients with renal impairment, a dose reduction of lamivudine is required due to decreased clearance. Therefore DOVATO is not recommended for use in patients with a creatinine clearance less than 30 mL/min (see PHARMACOLOGY: Pharmacokinetics: Special patient populations under Actions).
Hepatic impairment: No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh grade A or B). No data are available for dolutegravir in patients with severe hepatic impairment (Child-Pugh grade C) (see PHARMACOLOGY: Pharmacokinetics: Special patient populations under Actions).