Dovato Dosage/Direction for Use

Dovato should be prescribed by physicians experienced in the management of HIV infection.
Posology: Adults and adolescents (above 12 years of age weighing at least 40 kg): The recommended dose of Dovato in adults and adolescents is one 50 mg/300 mg tablet once daily.
Dose adjustments: A separate preparation of dolutegravir is available where a dose adjustment is indicated due to drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir, see Precautions and Interactions). In these cases the physician should refer to the individual product information for dolutegravir.
Missed doses: If the patient misses a dose of Dovato, the patient should take Dovato as soon as possible, providing the next dose is not due within 4 hours. If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Elderly: There are limited data available on the use of Dovato in patients aged 65 years and over. No dose adjustment is necessary (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Dovato is not recommended for use in patients with a creatinine clearance <30 mL/min (see Pharmacology: Pharmacokinetics under Actions). No dose adjustment is required in patients with mild or moderate renal impairment. However, the lamivudine exposure is significantly increased in patients with a creatinine clearance <50 mL/min (see Precautions).
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); therefore Dovato should be used with caution in these patients (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Dovato in children aged less than 12 years and in adolescents weighing less than 40 kg have not been established. No data are available.
Method of administration: Oral use.
Dovato can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).