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Indication & Dosage

TIVICAY is a once-daily, unboosted integrase inhibitor.1

Indication:

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 Dosing Recommendations for TIVICAYGo to Top Close

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
 

20mg QD
(Taken as two 10mg tablets)

20 to less than 30

25mg QD

30 to less than 40
 

35mg QD
(Taken as one 25mg + one 10mg tablet)

40 or greater

50mg QD

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.

Missed doses

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.

References:

  1. TIVICAY Summary of Product Characteristics.

 

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies