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Therapy should be prescribed by a physician experienced in the management of HIV infection.
Posology: Adults, adolescents and children weighing at least 25 kg: The recommended dose of Kivexa is one tablet once daily.
Children Under 25 kg: Kivexa should not be administered to children who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced.
Kivexa is a fixed-dose tablet and should not be prescribed for patients requiring dose adjustments. Separate preparations of abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated. In these cases the physician should refer to the individual product information for these medicinal products.
Special Populations: Elderly: No pharmacokinetic data are currently available in patients over 65 years of age. Special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
Renal impairment: Kivexa is not recommended for use in patients with a creatinine clearance < 50 ml/min as necessary dose adjustment cannot be made (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Abacavir is primarily metabolised by the liver. No clinical data are available in patients with moderate or severe hepatic impairment, therefore the use of Kivexa is not recommended unless judged necessary. In patients with mild hepatic impairment (Child-Pugh score 5-6) close monitoring is required, including monitoring of abacavir plasma levels if feasible (see Pharmacology: Pharmacokinetics under Actions and Precautions).
Paediatric population: The safety and efficacy of Kivexa in children weighing less than 25 kg has not been established. Currently available data are described in Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions and Adverse Reactions but no recommendation on posology can be made.
Method of administration: Oral use.
Kivexa can be taken with or without food.
