RISPERDAL

What it is

RISPERDAL contains risperidone as the active ingredient and is available as 0.5, 1, 2, 3 and 4 mg oral film-coated tablets or as a 1 mg/mL oral solution.

Approved indications

— Treatment of schizophrenia and related psychoses. — Short term treatment of acute mania associated with bipolar 1 disorder. — Treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type. — Treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours such as aggression, impulsivity and self-injurious behaviours are prominent. — Treatment of behavioural disorders associated with autism in children and adolescents.

Dosing overview

In stable adult patients with schizophrenia, RISPERDAL may be given once daily or twice daily, with a recommended daily dose between 4 and 6 mg. For bipolar mania, RISPERDAL should be administered on a once daily basis, starting with 2 mg, with a dosing range of between 2–6 mg per day recommended. For dementia and other indications, dosing is weight-based and titrated gradually. In behavioural disturbances in dementia, a starting dose of 0.25 mg twice daily is recommended, individually adjusted by increments of 0.25 mg twice daily not more frequently than every other day if needed, with the optimum dose being 0.5 mg twice daily for most patients.

Key safety warnings

Due to the alpha-blocking activity of risperidone, orthostatic hypotension can occur, especially during the initial dose-titration period, and RISPERDAL should be used with caution in patients with known cardiovascular disease such as heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease. Events of leukopenia, neutropenia and agranulocytosis have been reported with antipsychotic agents, including RISPERDAL, with agranulocytosis reported very rarely (less than 1 in 10,000 patients) during post-marketing surveillance. Patients with a history of a clinically significant low white blood cell count or drug-induced leukopenia/neutropenia should be monitored during the first few months of therapy. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary dyskinetic, rhythmical movements including those of the tongue and/or face, may develop in patients treated with conventional neuroleptics, and although this syndrome appears to be most prevalent in the elderly, especially elderly females, it is impossible to predict at the onset of treatment which patients are likely to develop it. Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including RISPERDAL, and epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemia-related adverse events in patients treated with atypical antipsychotics. Elderly patients with dementia treated with atypical antipsychotic medicines have an increased mortality compared to placebo, with incidence of mortality in placebo-controlled trials with RISPERDAL in this population being 4.0% for RISPERDAL treated patients and 3.1% for placebo-treated patients. Neuroleptic Malignant Syndrome is a potentially fatal symptom complex that has been reported in association with antipsychotic drugs, including risperidone, with clinical manifestations including hyperthermia, muscle rigidity, altered mental status and evidence of autonomic instability.

Contraindications

RISPERDAL is contraindicated in patients with a known hypersensitivity to the medicine or any of its excipients.

PBS listing

The oral solution 1 mg per mL is listed on the PBS with 4 items under authority required and streamlined restrictions, with an ex-manufacturer price of A$94.36.

Regulatory history

RISPERDAL risperidone 1 mg, 3 mg and 4 mg tablets were first registered on the ARTG on 30 November 1993, followed by the 2 mg tablet on 30 May 1994 and the 0.5 mg tablet on 4 January 2000. The oral solution 1 mg/mL was first listed on the ARTG on 13 September 1996. In March 2024, the PBAC recommended RISPERDAL for schizophrenia.