LURACOR

What it is

LURACOR is lurasidone hydrochloride supplied as film-coated tablets in three strengths: 20 mg, 40 mg, and 80 mg.

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. Patients should be treated with the lowest effective dose that provides optimal clinical response and tolerability, which is expected to be 40 mg or 80 mg once daily for most patients. The maximum recommended dose is 160 mg per day. LURACOR should be taken with food. For adolescent patients aged 13 to 17 years with schizophrenia, the recommended starting dose is 40 mg per day, and the maximum recommended dose is 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. LURACOR 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, 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. Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended. LURACOR 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, hypokalaemia, and in concomitant use with other medicinal products thought to prolong the QT interval. Tardive dyskinesia is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements that can develop in patients treated with antipsychotic medicines, including lurasidone. Although the prevalence of the syndrome appears to be highest amongst the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome.

Contraindications

LURACOR is contraindicated in any patient with a known hypersensitivity to lurasidone hydrochloride or any components in the formulation. LURACOR is contraindicated for use in combination with strong CYP3A4 inhibitors (such as ketoconazole, clarithromycin, ritonavir, and voriconazole) and strong CYP3A4 inducers (such as rifampin, St. John's wort, phenytoin, and carbamazepine).

PBS listing

No PBS listing information is available in the provided source documents.

Regulatory history

LURACOR was first listed on the Australian Register of Therapeutic Goods on 16 October 2020 in three strengths (20 mg, 40 mg, and 80 mg film-coated tablets), available in blister pack and bottle presentations.