TIVICAY

What it is

TIVICAY is a film-coated tablet containing dolutegravir sodium 50 mg , available in multiple strengths. TIVICAY is indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults and children of at least 4 weeks in age or older and weighing 3 kg or more.

Approved indications

— Human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults — Human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in children of at least 4 weeks in age or older and weighing 3 kg or more

Key safety warnings

Hypersensitivity reactions have been reported with dolutegravir and were characterised by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. TIVICAY should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop, including severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia, or angioedema. Hepatic adverse events have been reported in patients receiving dolutegravir-containing regimens. Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations. Monitoring for hepatotoxicity is recommended. Depressive disorders have been reported with dolutegravir. Patients with severe depressive symptoms should be promptly evaluated to assess whether the symptoms are related to TIVICAY and to determine whether the risks of continued therapy outweigh the benefits.

Contraindications

TIVICAY is contraindicated in patients with known hypersensitivity to dolutegravir or to any of the excipients.

PBS listing

TIVICAY 50 mg tablet is listed on the PBS with streamlined restriction and an ex-manufacturer price of A$600.66.

Regulatory history

TIVICAY dolutegravir 50 mg film-coated tablet was first registered on the ARTG on 17 January 2014. In November 2017, the PBAC recommended an amendment to expand the eligibility criteria for dolutegravir to include patients with HIV-1 infection who are initiating antiretroviral therapy. In July 2020, the PBAC recommended a change for use in antiretroviral therapy-experienced patients. The TGA approved TIVICAY and TIVICAY PD on 15 September 2021 for the treatment of HIV infection in combination with other antiretroviral agents in adults and children of at least 4 weeks in age or older and weighing 3 kg or more, alongside registration of a 5 mg dispersible tablet formulation with updated dosing recommendations for children.