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

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**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_).