LAVIONE

What it is

LAVIONE contains lurasidone hydrochloride and is available in 40 mg and 80 mg film-coated tablets. Lurasidone's efficacy is believed to be mediated mainly through antagonist activity at dopamine D2 and 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. 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. LAVIONE should be taken with food. For adolescents, 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. Lurasidone is not approved for the treatment of elderly patients with dementia-related psychosis or behavioural disorders. Neuroleptic Malignant Syndrome, a potentially fatal symptom complex 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 this syndrome, or presents with unexplained high fever, all antipsychotic medicines, including lurasidone, must be discontinued. Weight gain has been observed with atypical antipsychotic use, and clinical monitoring of weight is recommended. The mean weight gain was 0.43 kg for lurasidone-treated patients compared to -0.02 kg for placebo-treated patients, with 4.8% of lurasidone-treated patients experiencing a ≥7% increase in body weight compared to 3.3% of placebo-treated patients. Lurasidone may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. Lurasidone 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, with the highest prevalence among the elderly, especially elderly women.

Contraindications

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

LAVIONE is not listed on the Pharmaceutical Benefits Scheme.

Regulatory history

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