APO-LURASIDONE

What it is

APO-LURASIDONE contains lurasidone hydrochloride and is available in three strengths: 20 mg, 40 mg, or 80 mg film-coated tablets. The efficacy of lurasidone is mediated mainly through antagonist activity at dopamine D2 and 5-hydroxytryptamine (5-HT, serotonin) 5-HT2A receptors.

Approved indications

— Treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

Dosing overview

The recommended starting dose is 40 mg once daily, with patients expected to be treated with the lowest effective dose of 40 mg or 80 mg once daily for most patients. Doses above 80 mg may be considered for certain patients based on individual clinical judgement, with a maximum recommended dose of 160 mg per day. APO-LURASIDONE should be taken with food. For adolescent patients aged 13 to 17 years with schizophrenia, the recommended starting dose is 40 mg per day with a maximum recommended dose of 80 mg per day.

Key safety warnings

Elderly patients with dementia-related psychosis treated with atypical antipsychotics are at an increased risk of death compared to placebo. APO-LURASIDONE is not approved for the treatment of elderly patients with dementia-related psychosis or behavioural disorders. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported in association with administration of antipsychotic medicines, including lurasidone. If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including lurasidone, must be discontinued. Lurasidone should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold, for example Alzheimer's dementia. Lurasidone may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. Caution should be exercised when lurasidone is prescribed in patients with known cardiovascular disease or family history of QT prolongation, hyperkalaemia, and in concomitant use with other medicinal products thought to prolong the QT interval. Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products, and all possible risk factors for VTE should be identified before and during treatment with lurasidone and preventive measures undertaken. Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Weight gain has been observed with atypical antipsychotic use, and clinical monitoring of weight is recommended.

Contraindications

APO-LURASIDONE is contraindicated in any patient with a known hypersensitivity to lurasidone hydrochloride or any components in the formulation. Lurasidone is contraindicated with strong CYP3A4 inhibitors (for example ketoconazole, clarithromycin, ritonavir, and voriconazole) and strong CYP3A4 inducers (for example rifampin, St. John's wort, phenytoin, and carbamazepine).

Regulatory history

APO-LURASIDONE lurasidone hydrochloride 20 mg, 40 mg and 80 mg film-coated tablets were first listed on the ARTG on 24 June 2020.