What is the recommended dosing for Latuda (lurasidone)?

Latuda (Lurasidone) Dosing

For bipolar I depression, start lurasidone at 20 mg once daily with food (at least 350 calories), with a maximum dose of 120 mg/day; for schizophrenia, start at 40 mg once daily with food, with a recommended range of 40-160 mg/day. 1

Bipolar I Depression Dosing

Adults

• Starting dose: 20 mg once daily 1
• No initial titration required 1
• Effective dose range: 20-120 mg/day as monotherapy or adjunctive to lithium/valproate 1, 2
• Maximum dose: 120 mg/day 1
• Important note: In monotherapy studies, higher doses (80-120 mg/day) did not provide additional efficacy compared to lower doses (20-60 mg/day) 1

Pediatric Patients (10-17 years)

• Starting dose: 20 mg once daily as monotherapy 1
• May increase after one week based on clinical response 1
• Effective range: 20-80 mg/day 1
• Maximum dose: 80 mg/day 1
• In clinical trials, 67% of patients received 20-40 mg once daily at study end 1

Schizophrenia Dosing

Adults

• Starting dose: 40 mg once daily 1, 3, 4
• No initial titration required 1, 3
• Recommended dose range: 40-160 mg/day 1, 3
• The FDA label states maximum recommended dose is 160 mg/day, though earlier labeling recommended 40-80 mg/day 1, 3
• Evidence suggests 80-160 mg doses show superior efficacy, with 160 mg recommended as most efficacious for acute schizophrenia 5

Critical Administration Requirements

Lurasidone MUST be taken with food (at least 350 calories) 1, 3, 4

• Administration with food increases absorption approximately 2-fold (AUC) and 3-fold (Cmax) 1
• All clinical trials demonstrating efficacy administered lurasidone with food 1
• Once-daily dosing regimen 1, 3, 4

Dose Modifications for Special Populations

Renal Impairment

• Moderate impairment (CrCl 30-<50 mL/min): Start at 20 mg/day, maximum 80 mg/day 1
• Severe impairment (CrCl <30 mL/min): Start at 20 mg/day, maximum 80 mg/day 1

Hepatic Impairment

• Moderate impairment (Child-Pugh 7-9): Start at 20 mg/day, maximum 80 mg/day 1
• Severe impairment (Child-Pugh 10-15): Start at 20 mg/day, maximum 40 mg/day 1

Drug Interactions

• Contraindicated with strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir) 1
• With moderate CYP3A4 inhibitors (diltiazem, erythromycin, fluconazole): Reduce lurasidone dose to half of original level, or if starting lurasidone, begin at 20 mg/day with maximum 80 mg/day 1

Safety and Tolerability Profile

Common Adverse Effects

• Most frequent: somnolence, akathisia, nausea, parkinsonism 3, 4, 6
• Risk of akathisia, nausea, somnolence, and extrapyramidal symptoms increases at 80-120 mg doses 5
• These effects typically occur early in treatment 4

Metabolic Advantages

• Minimal weight gain 3, 4, 6, 2
• No clinically meaningful alterations in glucose or lipids 3, 4, 6, 2
• No cardiovascular effects (orthostatic hypotension, QTc prolongation) 3, 4, 6
• Particularly suitable for patients with obesity, diabetes, dyslipidemia, or cardiovascular comorbidities 4

Dopaminergic Side Effects

• Parkinsonism and elevated prolactin are rare and mild 2

Clinical Pearls

• Duration of effectiveness beyond 6 weeks has not been established in controlled studies; periodically re-evaluate long-term use 1
• For schizophrenia, 40 mg may be insufficient; consider starting at 80 mg or rapidly titrating to this dose based on meta-analysis data 5
• The favorable metabolic profile distinguishes lurasidone from many other second-generation antipsychotics 3, 4, 6