RISVAN

What it is

Risperidone Sandoz contains risperidone in tablet strengths of 0.5 mg, 1 mg, 2 mg, 3 mg, or 4 mg.

Approved indications

— Treatment of schizophrenia and related psychoses. — Short-term treatment of acute mania associated with bipolar I 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 disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. — Treatment of behavioural disorders associated with autism in children and adolescents.

Dosing overview

Dosing varies by indication. For schizophrenia in adults, patients may start with risperidone 1 mg twice daily, with dosage increased on the second day to 2 mg twice daily, after which the dosage can be maintained unchanged or further individualised as needed. In stable patients, risperidone may be given once daily or twice daily, with a recommended daily dose between 4 and 6 mg. For bipolar mania, risperidone should be administered once daily, starting with 2 mg, with dosage adjustments at intervals of not less than 24 hours in increments of 1 mg/day, and a recommended dosing range of between 2 and 6 mg/day. For 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, with an optimum dose of 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 clinically significant hypotension has been observed with concomitant use of risperidone and antihypertensive treatment. Patients should be titrated gradually in view of the risk of first dose orthostatic hypotension. Events of leukopenia, neutropenia and agranulocytosis have been reported with antipsychotic agents, including risperidone, 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 and discontinuation of risperidone should be considered at the first sign of clinically significant decline in white blood cell count in the absence of other causative factors. 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. Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including risperidone. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia and weakness. Significant weight gain has been reported and monitoring weight gain is advisable when risperidone is being used. Elderly patients with dementia treated with atypical antipsychotic medicines have an increased mortality compared to placebo, with an incidence of mortality of 4.0% for risperidone treated patients and 3.1% for placebo treated patients in placebo controlled trials. In placebo controlled trials in elderly patients with dementia there was a significantly higher incidence of cerebrovascular adverse events, such as stroke and transient ischaemic attacks, with cerebrovascular adverse events occurring in 3.3% of patients treated with risperidone and 1.2% of patients treated with placebo.

Contraindications

Known hypersensitivity to the medicine or any of its excipients.

PBS listing

Risperidone Sandoz intramuscular injection (modified release) is listed on the PBS in two strengths: a set containing 1 pre-filled syringe powder for injection 100 mg and 1 pre-filled syringe diluent with an ex-manufacturer price of A$225.16, and a set containing 1 pre-filled syringe powder for injection 75 mg and 1 pre-filled syringe diluent with an ex-manufacturer price of A$183.21, both with streamlined restriction.

Regulatory history

Risperidone Sandoz modified release powder for injection in 75 mg and 100 mg strengths was first listed on the ARTG on 21 December 2023.