LATUDA

What it is

Lurasidone is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. It has antagonist activity on the dopamine 2 (D2) and serotonin (5-HT)-2A receptors. LATUDA tablets are available in 40 mg or 80 mg strengths of lurasidone hydrochloride. LATUDA should be taken with food.

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. Initial dose titration is not required. 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. Doses above 80 mg may be considered for certain patients based on individual clinical judgment, with a maximum recommended dose of 160 mg/day. For adolescents, the recommended starting dose is 40 mg/day with a maximum recommended dose of 80 mg/day.

Key safety warnings

**Neuroleptic Malignant Syndrome** 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 LATUDA. 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 LATUDA, must be discontinued. **Tardive Dyskinesia** Tardive dyskinesia is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements that can develop in patients treated with antipsychotic medicines, including lurasidone. The risk of development of tardive dyskinesia may be reduced by using the lowest effective dose. **Weight Gain** Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended. The mean weight gain was 0.43 kg for LATUDA-treated patients compared to −0.02 kg for placebo-treated patients, with 4.8% of LATUDA-treated patients experiencing a ≥7% increase in body weight versus 3.3% for placebo. **Cardiovascular** LATUDA may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. LATUDA should be used with caution in patients with known cardiovascular disease (e.g. heart failure, history of myocardial infarction, ischaemia, or conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g. dehydration, hypovolaemia, and treatment with antihypertensive medications). **Hyperglycaemia and Diabetes Mellitus** 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. Patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia, and weakness. **Hyperprolactinaemia** As with other medicines that antagonise dopamine D2 receptors, LATUDA elevates prolactin levels. Galactorrhoea, amenorrhoea, gynecomastia, and impotence have been reported with prolactin-elevating compounds.

Contraindications

LATUDA is contraindicated in any patient with a known hypersensitivity to lurasidone HCl or any components in the formulation. LATUDA is contraindicated with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, ritonavir, and voriconazole) and strong CYP3A4 inducers (e.g. rifampin, St. John's wort, phenytoin, and carbamazepine).

PBS listing

No Pharmaceutical Benefits Scheme listing information is provided in the source documents.

Regulatory history

LATUDA was first listed on the ARTG on 16 April 2014. A revision to the Product Information occurred on 3 August 2023, with deletion of Black Triangle status.