Tivicay Dosage/Direction for Use

Tivicay 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.
Tivicay 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: In adolescents (12 to less than 18 years of age and weighing greater than or equal to 20 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.
Children aged at least 6 years and weighing at least 20 kg: In patients infected with HIV-1 without resistance to the integrase class, (6 to less than 12 years of age and weighing at least 20 kg), the recommended dose of dolutegravir film-coated tablets is 50 mg once daily.
There is insufficient and efficacy data available to recommend a dose for dolutegravir 50 mg film-coated tablets in children below age 6 or weighing less than 20 kg.
There is insufficient data to recommend a dose of dolutegravir film-coated tablets in integrase inhibitor resistance children.
Missed doses: If the patient misses a dose of Tivicay, the patient should take Tivicay as soon as possible, provided 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 subjects 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 Tivicay in children aged less than 6 years or weighing less than 20 kg has not yet been established. In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for Tivicay 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.
Tivicay can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions). In the presence of integrase class resistance, Tivicay should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see Pharmacology: Pharmacokinetics under Actions).