Lurasidone

LATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia. Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression). Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression). LATUDA is an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years). Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy. Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate

The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D 2 and serotonin Type 2 (5HT 2A ) receptor antagonism.

LATUDA should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of LATUDA. Indication Starting Dose Recommended Dose Schizophrenia – adults 40 mg per day 40 mg to 160 mg per day Schizophrenia –adolescents (13 to 17 years) 40 mg per day 40 mg to 80 mg per day Bipolar Depression - adults 20 mg per day 20 mg to 120 mg per day Bipolar Depression –pediatric patients (10 to 17 years) 20 mg per day 20 mg to 80 mg per day Moderate and Severe Renal Impairment: Recommended starting dose is 20 mg per day, and the maximum recommended dose is 80 mg per day. Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per day. The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment.

Known hypersensitivity to lurasidone HCl or any components in the formulation. Angioedema has been observed with lurasidone. Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.). Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). Known hypersensitivity to LATUDA or any components in the formulation. Concomitant use with a strong CYP3A4 inhibitor (e.g., ketoconazole). Concomitant use with a strong CYP3A4 inducer (e.g., rifampin).

Boxed warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients. Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors. Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack). Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. Tardive Dyskinesia: Discontinue if clinically appropriate. Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain. Hyperprolactinemia: Prolactin elevations may occur.

The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis Suicidal Thoughts and Behaviors Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis Neuroleptic Malignant Syndrome Tardive Dyskinesia Metabolic Changes Hyperprolactinemia Leukopenia, Neutropenia, and Agranulocytosis Orthostatic Hypotension and Syncope Falls Seizures Potential for Cognitive and Motor Impairment Body Temperature Dysregulation Activation of Mania/Hypomania Dysphagia Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies Commonly observed adverse reactions (incidence ≥ 5% and at least twice the rate for placebo) were: Adult patients with schizophrenia: somnolence, akathisia, extrapyramidal symptoms, and nausea…

Drugs Having Clinically Important Interactions with LATUDA Table 34: Clinically Important Drug Interactions with LATUDA Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone. Intervention: LATUDA should not be used concomitantly with strong CYP3A4 inhibitors. Examples: Ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone. Intervention: LATUDA dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4.

Store LATUDA tablets at 25°C (77°F), excursions permitted to 15° - 30°C (59° - 86°F).