Dovato should be prescribed by physicians experienced in the management of HIV infection.
Posology: Adults: The recommended dose of Dovato in adults 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 < 50 mL/min (see Pharmacology: Pharmacokinetics under Actions). No dose adjustment is required in patients with mild renal impairment.
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 paediatric patients have not been established.
Method of administration: Oral use.
Dovato can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).