ARIPENA

What it is

Aripena is aripiprazole monohydrate presented as a therapeutic kit containing a sterile, single-dose, lyophilised powder for reconstitution with water for injections to give a prolonged-release suspension for injection delivering 400 mg of aripiprazole per vial strength. Aripena is intended for intramuscular injection only.

Approved indications

— Acute and maintenance treatment of schizophrenia in adults. — 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 Aripena is 400 mg, administered once-monthly by a healthcare professional 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, tolerability must be established with oral aripiprazole prior to initiating Aripena; due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. After the first Aripena 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 to 300 mg once-monthly should be considered.

Key safety warnings

Elderly patients with dementia-related psychosis treated with atypical antipsychotics including aripiprazole are at an increased risk of death compared to placebo, with a risk between 1.6 to 1.7 times that of placebo-treated patients; over a typical 10-week controlled trial, the death rate in drug-treated patients was about 4.5% compared to about 2.6% in the placebo group. Cerebrovascular adverse reactions including stroke and transient ischaemic attack were reported in elderly patients (mean age 84 years), with 1.3% of aripiprazole-treated patients experiencing these events compared with 0.6% of placebo-treated patients. Aripena is not indicated for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome is a potentially fatal symptom complex; rare cases were reported during aripiprazole treatment, with clinical manifestations including hyperpyrexia, muscle rigidity, altered mental status and autonomic instability, plus potentially elevated creatine phosphokinase, myoglobinuria and acute renal failure. Hyperglycaemia in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics including aripiprazole; epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemia-related adverse events in patients treated with atypical antipsychotics. All patients starting treatment with atypical antipsychotics including aripiprazole should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment; any patient should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia and weakness. In clinical trials of one year or less duration there were uncommon reports of treatment-emergent tardive dyskinesia during aripiprazole treatment; the risk of tardive dyskinesia increases with long-term exposure to antipsychotic treatment, and if signs and symptoms appear, dose reduction or discontinuation should be considered. Uncommon cases of seizures were experienced during aripiprazole treatment; aripiprazole should be used cautiously in patients with a history of seizure disorder or conditions associated with seizures. Events of leukopenia and neutropenia have been reported temporally related to antipsychotic agents including aripiprazole, and agranulocytosis has also been reported; patients with a history of clinically significant low white blood cell count or drug-induced leukopenia should have complete blood cell counts monitored frequently during the first few months of therapy. Patients can experience increased urges particularly for gambling and inability to control these urges while taking aripiprazole; other urges reported include increased sexual urges, compulsive spending, binge or compulsive eating, and other impulsive and compulsive behaviours, and prescribers should ask patients or caregivers specifically about development of new or increased such urges.

Contraindications

Hypersensitivity to aripiprazole or any of the excipients.

PBS listing

Aripena aripiprazole 400 mg powder and diluent for prolonged release suspension for injection vial kit was first listed on the ARTG on 12 February 2025. No additional PBS listing information is available from the provided sources.

Regulatory history

Aripena aripiprazole 400 mg powder and diluent for prolonged release suspension for injection vial kit (ARTG 444951) was first listed on 12 February 2025 under licence category RE. A 300 mg variant (ARTG 485480) was subsequently listed on 5 November 2025 under licence category RE.