ABILIFY

What it is

Abilify contains aripiprazole as the active ingredient. Abilify is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets. Abilify tablets contain lactose monohydrate.

Approved indications

— Treatment of schizophrenia including maintenance of clinical improvement during continuation therapy. — Acute treatment of manic or mixed episodes associated with Bipolar I Disorder in adults as monotherapy and in combination with lithium or valproate. — Maintenance treatment of manic or mixed episodes in Bipolar I Disorder in adults as monotherapy.

Dosing overview

No dosage adjustment is required in adult patients with renal impairment. No dosage adjustment is required for adult patients with hepatic impairment. No dosage adjustment is required for patients aged 65 years or older.

Key safety warnings

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to about 2.6% in the placebo group. The possibility of a suicide attempt is inherent in psychotic illnesses and Bipolar I Disorder and close supervision of high-risk patients should accompany drug therapy. Prescriptions for Abilify should be written for the smallest quantity consistent with good patient management, in order to reduce the risk of overdose. Sleep apnoea and related disorders have been reported in patients treated with aripiprazole, with or without prior history of sleep apnoea. Aripiprazole should be used with caution in patients who have sleep apnoea or risk factors for developing sleep apnoea, which include overweight/obesity, males, and concomitant use of central nervous system depressants. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs including Abilify. Rare cases of NMS occurred during aripiprazole treatment in the worldwide clinical database. Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients with atypical antipsychotics including Abilify. Epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemia-related adverse events in patients treated with atypical antipsychotics. The risk of tardive dyskinesia increases with long-term exposure to antipsychotic treatment. If signs and symptoms of tardive dyskinesia appear in a patient on Abilify, a dose reduction or drug discontinuation should be considered. These symptoms can temporally deteriorate or even arise after discontinuation of treatment.

Contraindications

Abilify is contraindicated in patients who are hypersensitive to aripiprazole or any of the excipients.

PBS listing

Abilify powder for injection is listed on the PBS in 300 mg and 400 mg strengths with streamlined authority required restriction. Ex-manufacturer prices are A$252.36 for the 300 mg strength and A$315.46 for the 400 mg strength.

Regulatory history

Abilify aripiprazole tablets in strengths of 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg were first registered on the Australian Register of Therapeutic Goods on 21 May 2003. In December 2024, the PBAC recommended listing of aripiprazole once per 2-month injection for maintenance treatment of schizophrenia in patients stabilised on the once monthly formulation, with a streamlined authority required restriction.