Indication & Dosage
TIVICAY is a once-daily, unboosted integrase inhibitor.1
Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age.1
|Adult patients without documented or clinically suspected resistance to the integrase class1||One 50-mg tablet, QD*
* Tivicay should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin).
|Adult patients with resistance to the integrase class (documented or clinically suspected)1||One 50-mg tablet, BID**
** 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.
The decision to use dolutegravir for such patients should be informed by the integrase resistance pattern.
Co-administration of Tivicay with some medicines should be avoided in this population (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin)
In the presence of INI class resistance, TIVICAY should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations).
Women of Childbearing Potential:
Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of dolutegravir. WOCBP who are taking dolutegravir should use effective contraception throughout treatment.1
Adolescent Dosing Recommendations for TIVICAY
|Adolescents (12 to less than 18 years of age and weighing at least 40kg) infected with HIV-1 without resistance to the integrase class1||One 50mg tablet, QD±
± In the presence of integrase inhibitor resistance, there is insufficient data to recommend a dose for dolutegravir in adolescents.
Paediatric Dosing Recommendations for TIVICAY
Children (6 to less than 12 years of age and weighing at least 15kg) infected with HIV-1 without resistance to the integrase class is determined according to the weight of the child1 ‡
|Body weight (kg)||Dose|
|15 to less than 20
|20 to less than 30||
|30 to less than 40
|40 or greater||
The specific dosage recommendation for the 10mg tablet, as specified above should be followed. Therefore, the 50mg once daily dose should not be given as five 10mg tablets.
‡ In the presence of integrase inhibitor resistance, there is insufficient data to recommend a dose for dolutegravir in children.
If the patient misses a dose of Tivicay, the patient should take Tivicay 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.
For further information, please see the Summary of Product Characteristics.