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MYLTEGA should be prescribed by physicians experienced in the management of HIV infection.
Posology: Adults: Patients infected with HIV-1 without documented or clinically suspected resistance to the integrase class: The recommended dose of dolutegravir is 50 mg (one tablet) orally once daily.
MYLTEGA should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin). Refer to Interactions.
Patients infected with HIV-1 with resistance to the integrase class (documented or clinically suspected): The recommended dose of dolutegravir is 50 mg (one tablet) twice daily.
In the presence of documented resistance that includes Q148 + ≥ 2 secondary mutations from G140A/C/S, E138A/K/T, L74I, modelling suggests that an increased dose may be considered for patients with limited treatment options (less than 2 active agents) due to advanced multi class resistance (see Pharmacology: Pharmacokinetics under Actions).
The decision to use dolutegravir for such patients should be informed by the integrase resistance pattern (see Pharmacology: Pharmacodynamics under Actions).
Adolescents aged 12 and above: In adolescents (12 to less than 18 years of age and weighing at least 40 kg) infected with HIV-1 without resistance to the integrase class, the recommended dose of dolutegravir is 50 mg once daily. In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in adolescents.
Missed doses: If the patient misses a dose of MYLTEGA, the patient should take MYLTEGA 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 dolutegravir in patients aged 65 years and over. There is no evidence that elderly patients require a different dose than younger adult patients (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dosage adjustment is required in patients with mild, moderate or severe (CrCl <30 mL/min, not on dialysis) renal impairment. Limited data are available in patients receiving dialysis, although differences in pharmacokinetics are not expected in this population (see Pharmacology: Pharmacokinetics under Actions).
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 dolutegravir should be used with caution in these patients (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of MYLTEGA in children aged less than 12 years or weighing less than 40 kg has not yet been established. In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for MYLTEGA in children and adolescents. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions, but no recommendation on a posology can be made.
Method of administration: Oral use.
MYLTEGA can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions). In the presence of integrase class resistance, MYLTEGA should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see Pharmacology: Pharmacokinetics under Actions).
