Dolutegravir sodium

Red

Brand Name(s):Tivicay

Indication:HIV in combination with other anti-retroviral medicinal products infected adults, adolescents and children aged <4 weeksand weighing <3kg

Rationale:1,2

Considered:Feb-14

Review Date:Jun-26

Comments:
A dispersible formulation of dolutegravir is licensed and suitable for use in children aged ?4 weeks and weighing ?3kg.

There is potential for confusion with other Tivicay film-coated tablets, so care is required when selecting products. The bioavailability of film-coated tablets and dispersible tablets are not comparable and the products should not be interchanged. The specific dosing recommendations for each formulation should be followed.

Drug Safety Update
Dolutegravir (Tivicay, Triumeq, Juluca): signal of increased risk of neural tube defects; do not prescribe to women seeking to become pregnant; exclude pregnancy before initiation and advise use of effective contraception
June 2018 ………………………… Update 2020 – Dolutegravir must now not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of organic cation transporter 2, including but not limited to fampridine