REXULTI

What it is

REXULTI contains brexpiprazole, a novel atypical antipsychotic agent. REXULTI is available as 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tablets for oral use.

Approved indications

— Treatment of schizophrenia. — Treatment of agitation associated with Alzheimer's dementia (AAD), in patients who are unresponsive to non-pharmacological interventions.

Dosing overview

Key safety warnings

The safety and efficacy of REXULTI in patients with schizophrenia 65 years of age or older, or in patients with AAD 90 years of age or older, have not been established, and caution should be used when treating elderly patients. There are no placebo-controlled trial data to support treatment beyond 12 weeks in patients with agitation associated with Alzheimer's dementia who are unresponsive to non-pharmacological interventions. Prior to initiation and during REXULTI treatment, patients with agitation in Alzheimer's dementia should be evaluated and appropriately treated for reversible factors leading to agitation such as pain, infection, polypharmacy, and acute delirium, and should have been found unresponsive to non-pharmacological interventions.

Contraindications

No contraindications are described in the provided product information.

PBS listing

REXULTI is listed on the PBS in strengths of 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg tablets with streamlined restriction. The ex-manufacturer price for each strength is A$116.00.

Regulatory history

REXULTI received ARTG registration for six strengths (0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg) on 19 May 2017. The PBAC recommended REXULTI in March 2017 for the treatment of schizophrenia on a streamlined authority-required basis, with cost minimisation compared to lurasidone. In July 2025, the PBAC recommended a new 500 microgram strength under the same conditions as the current PBS-listed strengths.