DOVATO FILM-COATED TABLET 50MG/300MG

Indications

DOVATO is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age weighing at least 40 kg, who have no known or suspected resistance to either antiretroviral component.

Contraindications

• DOVATO is contraindicated in patients with known hypersensitivity to dolutegravir or lamivudine, or to any of the excipients.

• DOVATO must not be administered concurrently with medicinal products with narrow therapeutic windows, that are substrates of organic cation transporter 2 (OCT2), including but not limited to dofetilide, pilsicainide or fampridine (also known as dalfampridine; see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage and Administration

Pharmaceutical form: Film-coated tablet

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For patients with integrase inhibitor resistance, DOVATO is not recommended. In this case, the physician should refer to the dolutegravir ( 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 Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).