LURASIDONE-WGR

What it is

Lurasidone-WGR is a tablet containing lurasidone hydrochloride, available in strengths of 20 mg, 40 mg, or 80 mg.

Approved indications —

Schizophrenia in adults — Schizophrenia in adolescents aged 13 to 17 years

Dosing overview

The recommended starting dose is 40 mg once daily, and 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. The maximum recommended dose is 160 mg per day. Lurasidone-WGR should be taken with food. For adolescent patients aged 13 to 17 years, the recommended starting dose is 40 mg per day, and the maximum recommended dose is 80 mg per day. In patients with mild renal impairment, no dose adjustment is required. In patients with moderate or severe renal impairment, the recommended starting dose is 20 mg and the maximum dose should not exceed 80 mg once daily. No dose adjustment is required in patients with mild hepatic impairment. Dose adjustment is recommended in patients with moderate hepatic impairment, with a recommended starting dose of 20 mg and a maximum dose of 80 mg. Lurasidone-WGR is not recommended in patients with severe hepatic impairment.

Key safety warnings

In placebo-controlled trials with similar atypical antipsychotics in elderly subjects with dementia-related psychosis, there was a higher incidence of fatalities compared to placebo-treated subjects. Elderly patients with dementia-related psychosis treated with atypical antipsychotics are at an increased risk of death compared to placebo. A potentially fatal symptom complex called Neuroleptic Malignant Syndrome, characterised by high temperature, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported with antipsychotic medicines including lurasidone. Additional signs may include myoglobinuria and acute renal failure. If a patient develops signs and symptoms indicative of this syndrome, or presents with unexplained high fever, all antipsychotic medicines, including lurasidone-WGR, must be discontinued. Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended. Lurasidone-WGR may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. It should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that predispose the patient to hypotension. 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 appears to be highest amongst the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict which patients are likely to develop the syndrome. 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, and patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycaemia.

Contraindications

Lurasidone-WGR is contraindicated in any patient with a known hypersensitivity to lurasidone hydrochloride or any components in the formulation. It 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

Information regarding PBS listing status for Lurasidone-WGR is not available in the provided source documents.

Regulatory history

Lurasidone-WGR was first listed on the Australian Register of Therapeutic Goods on 17 April 2024. Three strengths are registered: 20 mg, 40 mg, and 80 mg film-coated tablets, each in blister pack format.