ISENTRESS

What it is

ISENTRESS is available as a 400 mg tablet and ISENTRESS HD as a 600 mg tablet, both containing raltegravir potassium. ISENTRESS or ISENTRESS HD is used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.

Approved indications

— Treatment of HIV-1 infection in adult and paediatric patients over the age of 2 years and weighing at least 25 kg, in combination with other antiretroviral agents.

Dosing overview

ISENTRESS 400 mg tablet is for twice daily use, while ISENTRESS HD 600 mg tablet is for once daily use. ISENTRESS or ISENTRESS HD can be administered with or without food. The formulations have different pharmacokinetic profiles, therefore the 400 mg tablet should not be substituted for the 600 mg tablet to create a 1200 mg once daily dose. It is not recommended to chew, crush or split the 400 mg tablet or 600 mg tablet.

Key safety warnings

There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection. The use of other active antiretroviral agents in combination with ISENTRESS is associated with a greater likelihood of treatment response.

PBS listing

Both the 400 mg and 600 mg tablet formulations are listed on the PBS with streamlined restriction. The ex-manufacturer price for each is A$420.52.

Regulatory history

ISENTRESS 400 mg tablet was first registered on the ARTG on 30 January 2008. ISENTRESS HD 600 mg tablet was first listed on the ARTG on 23 August 2017. In November 2017, the PBAC recommended a streamlined authority required listing of raltegravir 600 mg tablets (1,200 mg once daily) for HIV infection in combination with other antiretroviral agents on a cost minimisation basis with raltegravir 400 mg tablets twice daily. Also in November 2017, the PBAC recommended an amendment to expand the eligibility criteria for raltegravir to include patients with HIV-1 infection who are initiating antiretroviral therapy.