ABILIFY

What it is

Abilify Maintena is aripiprazole (as monohydrate) presented as a prolonged-release suspension for intramuscular injection. Aripiprazole is an atypical antipsychotic. The recommended starting and maintenance dose of Abilify Maintena is 400 mg.

Approved indications

— For the acute and maintenance treatment of schizophrenia in adults. — For maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy.

Dosing overview

The recommended starting and maintenance dose of Abilify Maintena is 400 mg. Abilify Maintena is to be administered by a healthcare professional only, once-monthly, as a single injection into the deltoid or gluteal muscle (no sooner than 26 days after the previous injection). For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with Abilify Maintena. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. After the first Abilify Maintena injection, treatment with oral aripiprazole (10 mg to 20 mg), or other oral antipsychotic, should be continued for 14 consecutive days to maintain therapeutic antipsychotic concentrations during initiation of therapy. If there are adverse reactions with the 400 mg dose, reduction of the dose to 300 mg once-monthly should be considered.

PBS listing

Abilify Maintena is listed on the PBS as a modified-release intramuscular injection in two strengths: 720 mg in 2.4 mL pre-filled syringe at A$504.72 ex-manufacturer price, and 960 mg in 3.2 mL pre-filled syringe at A$630.92 ex-manufacturer price. Both are listed with streamlined restriction.

Regulatory history

Abilify Maintena 300 mg and 400 mg powder formulations in vials were first listed on the ARTG on 2014-07-25. The TGA approved registration on 2014-07-22 for maintenance of clinical improvement in the treatment of schizophrenia. In July 2018, the PBAC recommended listing as a streamlined authority-required item for a new presentation of the 400 mg formulation. Pre-filled syringe presentations of 300 mg and 400 mg were first listed on the ARTG on 2018-05-07. In November 2021, the PBAC extended its recommendation for 12 months. In July 2025, the PBAC recommended new pre-filled syringe formulations (720 mg and 960 mg) on a cost-minimisation basis, with registration occurring on 2025-02-05.