Kivexa

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

TABLET

**Dosage and Administration** **Pharmaceutical Form: Film-coated tablets** Therapy should be initiated by a physician experienced in the management of HIV infection. _KIVEXA_ should not be administered to patients who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced. Separate preparations of abacavir ( _ZIAGEN_) and lamivudine ( _EPIVIR_) should be administered to patients weighing less than 25 kg. _KIVEXA_ can be taken with or without food. _KIVEXA_ 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 abacavir ( _ZIAGEN_) or lamivudine ( _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. **Populations** - **Adults and children weighing at least 25 kg** The recommended dose of _KIVEXA_ in adults and children weighing 25 kg or more is one tablet once daily. - **Children weighing less than 25 kg** _KIVEXA_ is not recommended for treatment of children weighing less than 25 kg as the necessary dose adjustment cannot be made. Physicians should refer to the individual product information for lamivudine and abacavir. - **Elderly** The pharmacokinetics of abacavir and lamivudine have not been studied in patients over 65 years of age. 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 abacavir is necessary in patients with renal impairment, a dose reduction of lamivudine is required due to decreased clearance. Therefore _KIVEXA_ is not recommended for use in patients with a creatinine clearance less than 30 ml/min ( _see Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - **Hepatic impairment** Abacavir is contraindicated in patients with moderate to severe hepatic impairment and dose reduction is required in patients with mild hepatic impairment (Child-Pugh grade A). As dose reduction is not possible with _KIVEXA_, the separate preparations of _ZIAGEN_ and _EPIVIR_ should be used when this is judged necessary. _KIVEXA_ is contraindicated for patients with moderate and severe hepatic impairment ( _see Pharmacokinetics – Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).