RISPA

What it is

Rispa is an antipsychotic belonging to a new class of antipsychotic agents, the benzisoxazole-derivatives. Rispa tablets contain 0.5, 1, 2, 3 or 4 mg of risperidone. Rispa is available as 0.5, 1, 2, 3 and 4 mg oral film-coated tablets.

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 (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. — Treatment of behavioural disorders associated with autism in children and adolescents.

Dosing overview

#### Schizophrenia Rispa tablets may be given once or twice daily. Patients, whether acute or chronic, may start with 1 mg Rispa tablets twice daily. The dosage may be increased on the second day to 2 mg twice daily. From then on the dosage can be maintained unchanged, or further individualised, if needed. In stable patients, Rispa tablets may be given once daily or twice daily, with a recommended daily dose between 4 and 6 mg. A starting dose of 0.5 mg twice daily is recommended in elderly patients in view of the increased risk of first dose orthostatic hypotension. This dosage can be individually adjusted with 0.5 mg b.i.d. increments to 1-2 mg twice daily. #### Bipolar mania Rispa tablets should be administered on a once daily basis, starting with 2 mg. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increment of 1 mg per day. A dosing range of between 2 and 6 mg per day is recommended. #### Behavioural disturbances in dementia A starting dose of 0.25 mg twice daily is recommended. This dosage can be individually adjusted by increments of 0.25 mg twice daily not more frequently than every other day, if needed. The optimum dose is 0.5 mg twice daily for most patients. #### Conduct and other disruptive behaviour disorders A starting dose of 0.5 mg once daily is recommended for subjects weighing 50 kg or greater. This dosage can be individually adjusted by increments of 0.5 mg once daily not more frequently than every other day, if needed. The optimum dose is 1 mg once daily for most patients. For subjects weighing less than 50 kg, a starting dose of 0.25 mg once daily is recommended. This dosage can be individually adjusted by increments of 0.25 mg once daily not more frequently than every other day, if needed. The optimum dose is 0.5 mg once daily for most patients. #### Behavioural disorders associated with autism Dosing should begin at 0.25 mg or 0.5 mg/day based upon weight. On day 4 of treatment the dose may be increased up to 0.5 or 1.0 mg/day. This dose should be maintained, and response assessed at approximately day 14. Dose increases may proceed at ≥2 week intervals in increments of 0.25 mg for patients < 20 kg or 0.5 mg for patients ≥20 kg. In clinical studies the maximum dose studied did not exceed a total daily dose of 1.5 mg in patients < 20 kg, 2.5 mg in patients ≥ 20 kg or 3.5 mg in patients >45 kg.

Key safety warnings

Elderly patients with dementia treated with atypical antipsychotic medicines have an increased mortality compared to placebo. In placebo-controlled trials with risperidone tablets in this population, the incidence of mortality was 4.0% for risperidone tablets treated patients and 3.1% for placebo-treated patients. In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence of cerebrovascular adverse events, such as stroke (including fatalities) and transient ischaemic attacks in patients treated with risperidone tablets compared to patients treated with placebo. Cerebrovascular adverse events occurred in 3.3% of patients treated with risperidone and 1.2% of patients treated with placebo. Due to the alpha-blocking activity of risperidone, orthostatic hypotension can occur, especially during the initial dose-titration period. Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment. Events of leukopenia, neutropenia and agranulocytosis have been reported with antipsychotic agents, including risperidone. Agranulocytosis has been reported very rarely during post-marketing surveillance. Neuroleptic Malignant Syndrome is a potentially fatal symptom complex that has been reported in association with antipsychotic drugs, including risperidone. Clinical manifestations of NMS are hyperthermia, muscle rigidity, altered mental status (including catatonic signs) and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, cardiac arrhythmias and diaphoresis). Classical neuroleptics are known to lower the seizure threshold. Risperidone tablets have not been studied in patients who also have epilepsy. In clinical trials, seizures have occurred in a few risperidone tablets-treated patients. 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 tablets. Significant weight gain has been reported. Monitoring weight gain is advisable when risperidone tablets are being used.

Contraindications

Risperidone tablets are contraindicated in patients with a known hypersensitivity to the medicine or any of its excipients.

PBS listing

Information on PBS listing is not available in the provided sources.

Regulatory history

Rispa was first listed on the ARTG on 2010-07-23 with five variants registered across 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg film-coated tablet blister packs.