TIVICAY TABLET 50MG

GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS) - UNITED KINGDOMDELPHARM POZNAŃ S.A. (POLAND)🇸🇬 Health Sciences Authority

Approval Date: Jul 31, 2014
Approval ID: a3c83bb9e44f7636
Company: GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS) - UNITED KINGDOMDELPHARM POZNAŃ S.A. (POLAND)
Type: Therapeutic

Approval Details

Approval Id: a3c83bb9e44f7636
Drug Name: TIVICAY TABLET 50MG
Product Name: TIVICAY TABLET 50MG
Approval Number: SIN14579P
Approval Date: 2014-07-31
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 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 is available as film-coated tablets for patients aged at least 6 years and weighing at least 20 kg. TIVICAY is also available as dispersible tablets for patients aged at least 4 weeks and weighing at least 3 kg, or for patients in whom film-coated tablets are not appropriate. The bioavailability of film-coated tablets and dispersible tablets is not comparable therefore they must not be used as direct replacements (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For example, the recommended adult dose for film-coated tablets is 50 mg versus 30 mg for dispersible tablets. Patients changing between film-coated and dispersible tablets should follow the dosing recommendations that are specific for the formulation. 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 and Children aged at least 6 years and weighing at least 20 kg In patients who have not previously been treated with an integrase inhibitor (6 to less than 18 years of age and weighing greater than or equal to 20 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 children and adolescents under 18 years of age. To reduce the risk of choking, do not swallow more than one tablet at a time, and where possible, children weighing 14 to less than 20 kg should preferentially take the dispersible tablet formulation. TIVICAY 50mg Film-Coated Tablet is not recommended for use in children below age 6 or weighing less than 20kg. 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).
Route Of Administration: ORAL
Indication Info: Indications TIVICAY film-coated tablets 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 20 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: <ul> <li>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.</li> </ul>
Contraindications: 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.
Atc Code: J05AX12
Atc Item Name: xj 05 ax 12
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD

Active Ingredients

DOLUTEGRAVIR SODIUM 52.6MG EQV DOLUTEGRAVIR

50mg

DOLUTEGRAVIR SODIUM 52.6MG EQV DOLUTEGRAVIR

50mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jul 31, 2014

Approval ID

a3c83bb9e44f7636

Type

Therapeutic

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