TIVICAY TABLET 50MG [SIN14579P]

Product Info

TIVICAY TABLET 50MG

[SIN14579P]

Indications

TIVICAY is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children aged 6 years and older and weighing at least 15 kg (see Warnings and Precautions – Dual regimens – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The following should be considered prior to initiating treatment with TIVICAY:

• Poor virologic response was observed in subjects treated with TIVICAY 50 mg twice daily with an integrase strand transfer inhibitor (INI)-resistance Q148H/K/R substitution plus 2 or more additional INI-resistance substitutions, including, but not limited to L74I, E138A/K/T and G140A/C/S.

Dosage and Administration

Pharmaceutical form:

Film-coated tablets.

Posology

TIVICAY therapy should be initiated by a physician experienced in the management of HIV infection.

TIVICAY can be taken with or without food.

Method of Administration

Adults

Patients infected with HIV-1 without documented or clinically suspected resistance to the integrase class

The recommended dose of TIVICAY is 50 mg once daily.

TIVICAY should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin) (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients infected with HIV-1 with resistance to the integrase class (documented or clinically suspected)

The recommended dose of TIVICAY is 50 mg twice daily. The decision to use TIVICAY for such patients should be informed by the integrase resistance pattern (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Co-administration of TIVICAY with some medicines should be avoided in this population (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin) (see Warnings and Precautions and Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adolescents

In patients who have not previously been treated with an integrase inhibitor (12 to less than 18 years of age and weighing greater than or equal to 40 kg), the recommended dose of TIVICAY is 50 mg once daily.

TIVICAY should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin) (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

There are insufficient data to recommend a dose for TIVICAY in integrase inhibitor resistant adolescents under 18 years of age.

Children

In patients infected with HIV-1 who have not previously been treated with an integrase inhibitor, the recommended dose of TIVICAY in children (6 to less than 12 years of age) is determined according to the weight of the child. Dose recommendations according to weight are presented in the table below.

The weight-based once daily dose of TIVICAY should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin) (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

There are insufficient safety and efficacy data available to recommend a dose for TIVICAY in children below age 6 or weighing less than 15 kg.

There are insufficient data to recommend a dose for TIVICAY in integrase inhibitor resistant children.

Elderly

There are limited data available on the use of TIVICAY 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).

Renal impairment

No dosage adjustment is required in patients with mild, moderate or severe (creatinine clearance (CrCl) <30 mL/min, not on dialysis) renal impairment. Limited data are available in subjects receiving dialysis, although differences in pharmacokinetics are not expected in this population (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 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).

Contraindications

TIVICAY 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).

TIVICAY is contraindicated in patients with known hypersensitivity to dolutegravir or to any of the excipients.