When should Caplyta (lurasidone) be taken, including time of day, dosing, and food requirements?

When to Administer Caplyta (Lurasidone)

Caplyta (lurasidone) must be taken once daily with food containing at least 350 calories to ensure adequate absorption and therapeutic effect. 1

Timing and Food Requirements

Critical Food Requirement

• Lurasidone must be taken with at least 350 calories of food to optimize bioavailability and ensure maximum drug exposure. 1, 2
• Taking lurasidone in a fasted state results in dramatically reduced absorption—approximately 50% lower Cmax and AUC compared to administration with adequate food. 2
• The caloric content is more important than fat composition; meals ranging from 350-1000 kcal produce similar adequate absorption regardless of fat content. 2

Time of Day

• Administer once daily at the same time each day, typically with dinner or the largest meal to ensure the 350-calorie requirement is met. 1, 3
• No specific time of day is mandated, but consistency in timing with a substantial meal is essential. 1

Dosing by Indication

Bipolar Depression (Adults)

• Starting dose: 20 mg once daily with food 1
• Recommended dose range: 20-120 mg once daily 1
• No initial titration is required; dose adjustments can be made based on clinical response. 4

Bipolar Depression (Pediatric Patients 10-17 years)

• Starting dose: 20 mg once daily with food 1
• Recommended dose range: 20-80 mg once daily 1

Dose Adjustments for Special Populations

Renal Impairment

• Moderate to severe renal impairment: Starting dose 20 mg/day, maximum 80 mg/day 1

Hepatic Impairment

• 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

Drug Interactions

• With moderate CYP3A4 inhibitors (e.g., diltiazem): Reduce dose to half the original level; starting dose 20 mg/day, maximum 80 mg/day 1
• With moderate CYP3A4 inducers: May need to increase lurasidone dose 1
• Strong CYP3A4 inhibitors (e.g., ketoconazole) and strong inducers (e.g., rifampin) are contraindicated with lurasidone. 1, 3

Common Pitfalls to Avoid

• Never allow patients to take lurasidone without adequate food—this is the most common error leading to treatment failure due to inadequate drug absorption. 2
• Do not exceed 80 mg/day in schizophrenia (note: higher doses up to 160 mg may be used in bipolar depression per FDA label, but doses above 80 mg do not appear more efficacious and may increase adverse effects like somnolence and akathisia). 1, 5, 3
• Avoid combining with strong CYP3A4 inhibitors or inducers—this is an absolute contraindication. 1