TRIUMEQ FILM COATED TABLET 50MG/600MG/300MG [SIN15100P]

Product Info

TRIUMEQ FILM COATED TABLET 50MG/600MG/300MG

[SIN15100P]

Indications

TRIUMEQ is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents from 12 years of age and weighing at least 40 kg, who are antiretroviral treatment-naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents in TRIUMEQ.

Dosage and Administration

Pharmaceutical form: Film-coated tablets

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

TRIUMEQ should not be administered to adults or adolescents who weigh less than 40 kg.

TRIUMEQ can be taken with or without food.

TRIUMEQ 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 or with mild hepatic impairment. Separate preparations of TIVICAY, ZIAGEN or EPIVIR should be administered in cases where discontinuation or dose adjustment is indicated. In these cases, the physician should refer to the individual product information for these medicinal products. A separate preparation of 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).

Since the recommended dose of dolutegravir is 50 mg twice daily for patients with resistance to integrase inhibitors, the use of TRIUMEQ is not recommended for patients with integrase inhibitor resistance.

Populations

• Adults and adolescents

  The recommended dose of TRIUMEQ in adults and adolescents weighing at least 40 kg is one tablet once daily.

• Children

  TRIUMEQ is not currently recommended for treatment of children less than 12 years of age or weighing less than 40 kg.

• Elderly

  There are limited data available on the use of TIVICAY, ZIAGEN and EPIVIR 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, renal and cardiac function, concomitant medicinal products or disease.

• Renal impairment

  Whilst no dosage adjustment of dolutegravir or abacavir is necessary in patients with renal impairment, a dose reduction of EPIVIR is required due to decreased clearance. Therefore, TRIUMEQ 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

  A dose reduction of ZIAGEN may be required for patients with mild hepatic impairment (Child-Pugh grade A). As dose reduction is not possible with TRIUMEQ, the separate preparations of TIVICAY, ZIAGEN and EPIVIR should be used when this is judged necessary. Abacavir is contraindicated in patients with moderate and severe hepatic impairment. TRIUMEQ is contraindicated in patients with moderate and severe hepatic impairment (Child-Pugh grade B or C) (see Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

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

TRIUMEQ 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).

TRIUMEQ is contraindicated in patients with moderate and severe hepatic impairment.