What is the maximum recommended dose of Latuda (lurasidone)?

Maximum Recommended Dose of Latuda (Lurasidone)

The maximum recommended dose of Latuda (lurasidone) is 120 mg per day for adults with bipolar depression and 80 mg per day for pediatric patients (10-17 years) with bipolar depression. 1

Adult Dosing Guidelines

• The recommended starting dose for adults is 20 mg given once daily, with no initial dose titration required 1
• Latuda has been shown to be effective in a dose range of 20 mg to 120 mg per day as monotherapy or as adjunctive therapy with lithium or valproate 1
• The maximum recommended dose for adults is 120 mg per day, though higher doses do not necessarily provide additional efficacy compared to lower doses 1, 2
• In monotherapy studies, the higher dose range (80-120 mg/day) did not provide additional efficacy, on average, compared to the lower dose range (20-60 mg/day) 1

Pediatric Dosing Guidelines

• For pediatric patients (10-17 years), the recommended starting dose is 20 mg given once daily as monotherapy 1
• The dose may be increased after one week based on clinical response 1
• Latuda has demonstrated efficacy in pediatric patients in a dose range of 20-80 mg per day 1
• The maximum recommended dose for pediatric patients is 80 mg per day 1
• In clinical studies, most pediatric patients (67%) received 20 mg or 40 mg once daily 1

Administration Requirements

• Latuda must be taken with food (at least 350 calories) 1, 2, 3
• Administration with food substantially increases absorption, increasing AUC approximately 2-fold and Cmax approximately 3-fold 1
• Once-daily dosing is the recommended administration schedule 1, 4

Dose Adjustments for Special Populations

• For patients with moderate renal impairment (creatinine clearance: 30 to <50 mL/min) or severe renal impairment (creatinine clearance <30 mL/min):

  • The recommended starting dose is 20 mg per day
  • The maximum dose should not exceed 80 mg per day 1

• For patients with moderate hepatic impairment (Child-Pugh Score = 7 to 9):

  • The recommended starting dose is 20 mg per day
  • The maximum dose should not exceed 80 mg per day 1

• For patients with severe hepatic impairment (Child-Pugh Score = 10 to 15):

  • The recommended starting dose is 20 mg per day
  • The maximum dose should not exceed 40 mg per day 1

Drug Interaction Considerations

• Latuda should not be used concomitantly with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) 1
• When used with moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, fluconazole):
  • The Latuda dose should be reduced to half of the original dose
  • The maximum recommended dose is 80 mg per day 1

Safety Profile

• Latuda has a favorable metabolic profile with minimal weight gain and no clinically meaningful alterations in glucose, lipids, or ECG QT interval 2, 4, 3
• Most common adverse events include somnolence, akathisia, nausea, and parkinsonism, especially early in treatment 2, 4, 3
• Latuda may be particularly beneficial for patients with schizophrenia who are overweight or have endocrine problems (diabetes, dyslipidemia) or comorbid cardiovascular conditions 3

Clinical Considerations

• The efficacy of Latuda for longer-term use (more than 6 weeks) has not been established in controlled studies 1
• Physicians should periodically re-evaluate the long-term usefulness of the drug for individual patients 1
• Latuda has been shown to have potential benefits for cognitive or depressive symptoms, though additional studies are needed 3