What is Latuda (lurasidone) used for?

What is Latuda (Lurasidone) Used For?

Latuda (lurasidone) is an atypical antipsychotic FDA-approved for treating depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults and adolescents aged 10-17 years, either as monotherapy or as adjunctive therapy with lithium or valproate. 1

FDA-Approved Indications

Bipolar I Depression

• Lurasidone is specifically indicated for major depressive episodes in patients with Bipolar I Disorder, not for mania or maintenance therapy. 1, 2
• The medication can be used as monotherapy in both adults and pediatric patients (10-17 years). 1
• It is also approved as adjunctive therapy combined with lithium or valproate in adults with bipolar depression. 1, 2

Schizophrenia (Additional Indication)

• Lurasidone is approved in the European Union and other countries for treating schizophrenia in adults and adolescents (13-17 years), though this is not the primary focus of the question. 3, 4

Dosing and Administration

Critical Administration Requirement

• Lurasidone MUST be taken with food (at least 350 calories) because food substantially increases absorption; inadequate food intake leads to unpredictable drug levels and increased side effects. 1, 5

Recommended Dosing for Bipolar Depression

• Adults: Starting dose is 20 mg per day, with a recommended range of 20-120 mg per day. 1
• Pediatric patients (10-17 years): Starting dose is 20 mg per day, with a recommended range of 20-80 mg per day. 1
• The medication is administered once daily with food. 1, 6

Clinical Efficacy

Evidence in Bipolar Depression

• In two 6-week placebo-controlled trials, lurasidone 20-120 mg/day reduced depressive symptoms by >50% on the Montgomery-Åsberg Depression Rating Scale (MADRS), with treatment effects significantly greater than placebo. 2
• The numbers needed to treat (NNT) to obtain an additional response (≥50% reduction in MADRS) were ≤7 across lurasidone groups, indicating clinically meaningful benefit. 2
• When used as adjunctive therapy with lithium or valproate, lurasidone showed significant differences favoring active treatment from weeks 2-5, though the primary endpoint at week 6 was not met in one trial. 2

Safety and Tolerability Profile

Common Adverse Effects

• The most frequently occurring adverse events in adults with bipolar depression include akathisia, extrapyramidal symptoms, and somnolence. 1, 2
• In pediatric patients (10-17 years), the most common adverse reactions are nausea, weight increase, and insomnia. 1

Metabolic Advantages

• Lurasidone demonstrates a favorable metabolic profile with minimal effects on weight gain, glucose, lipids, and ECG parameters compared to some other atypical antipsychotics. 2, 6, 4
• This metabolic neutrality makes it particularly valuable for patients at risk for metabolic syndrome. 2

Serious Warnings

• Lurasidone carries a boxed warning for increased mortality in elderly patients with dementia-related psychosis (though it is not approved for this use). 1
• A boxed warning also exists for increased risk of suicidal thoughts and behaviors in pediatric and young adult patients, requiring close monitoring for clinical worsening. 1

Contraindications and Drug Interactions

Absolute Contraindications

• Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole) is contraindicated. 1
• Concomitant use with strong CYP3A4 induces (e.g., rifampin) is contraindicated. 1
• Known hypersensitivity to lurasidone or any formulation components. 1

Dose Adjustments Required

• When used with moderate CYP3A4 inhibitors (e.g., diltiazem), reduce lurasidone dose to half the original level, with a maximum of 80 mg/day. 1
• Moderate to severe renal impairment: Starting dose 20 mg/day, maximum 80 mg/day. 1
• Moderate hepatic impairment: Starting dose 20 mg/day, maximum 80 mg/day. 1
• Severe hepatic impairment: Starting dose 20 mg/day, maximum 40 mg/day. 1

Important Clinical Considerations

Monitoring Requirements

• Monitor for neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes (hyperglycemia, dyslipidemia, weight gain), and hyperprolactinemia. 1
• Perform complete blood counts in patients with pre-existing low WBC or history of leukopenia/neutropenia, as rare cases of thrombocytopenia and myelosuppression have been reported. 1, 7
• Monitor for orthostatic hypotension and syncope, particularly in patients with cardiovascular disease. 1

Common Pitfalls to Avoid

• Never prescribe lurasidone without explicit instructions to take with food (≥350 calories), as this is the most common cause of treatment failure and increased side effects. 5, 1
• Do not use lurasidone for acute mania—it is indicated only for the depressive phase of Bipolar I Disorder. 1, 2
• Avoid combining with strong CYP3A4 inhibitors or inducers, as this is contraindicated. 1