Tivicay (dolutegravir) is an integrase strand transfer inhibitor (INSTI) that is indicated for use in combination with other antiretroviral (ARV) medicines for the treatment of HIV infection.
Tivicay was approved by the U.S. Food and Drug Administration (FDA) in August 20131; by the European Commission in January 20142; by the Canadian regulatory authority Health Canada in October 20133 and by the Japanese Pharmaceuticals and Medical Devices Agency in April 20144.
In June 2016, the FDA approved a reduction in the weight limit from at least 40kg to at least 30kg for the treatment of HIV with Tivicay, meaning children and adolescents aged 6 – 12 years old are eligible to receive this treatment option.
Tivicay is now available in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America. Click for details about the worldwide adult registration status of Tivicay and Triumeq.
In June 2020, the FDA approved Tivicay PD (dolutegravir) dispersible tablets for oral suspension, which are used in combination with other antiretroviral agents for the treatment of HIV infection in paediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg, as well as an extended indication to expand the use of the already approved Tivicay 50mg film-coated tablet (FCT) in paediatric HIV patients weighing 20kg and above.
Tivicay PD and the extended indication of the existing Tivicay 50mg FCT are both currently under review by the European Medicines Agency (EMA). Additional submissions to regulatory authorities around the world are ongoing. Submissions are currently underway in Botswana, Namibia, Malawi and Zimbabwe. as well as several other countries outside of Africa.
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Safety Information / Renseignements sur l’innocuité