What are the recommended dosing, administration with food, monitoring parameters, contraindications, and safety considerations for Latuda (lurasidone) in adults with schizophrenia or bipolar I depression?

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Latuda (Lurasidone) for Schizophrenia and Bipolar I Depression

Dosing and Administration

Latuda must be taken with food (at least 350 calories) because administration with food substantially increases absorption. 1

Recommended Dosing by Indication

For bipolar depression in adults:

  • Starting dose: 20 mg once daily 1
  • Recommended range: 20-120 mg per day 1
  • No initial titration required 2

For bipolar depression in pediatric patients (10-17 years):

  • Starting dose: 20 mg once daily 1
  • Recommended range: 20-80 mg per day 1

For schizophrenia in adults:

  • Starting dose: 40 mg once daily 1, 2
  • Recommended range: 40-160 mg per day 1, 2
  • Once-daily dosing regimen 2

For schizophrenia in adolescents (13-17 years):

  • Dose range: 20-80 mg per day 3

Dose Adjustments for Special Populations

Moderate to severe renal impairment:

  • Starting dose: 20 mg per day 1
  • Maximum dose: 80 mg per day 1

Moderate hepatic impairment:

  • Starting dose: 20 mg per day 1
  • Maximum dose: 80 mg per day 1

Severe hepatic impairment:

  • Starting dose: 20 mg per day 1
  • Maximum dose: 40 mg per day 1

Concomitant use with moderate CYP3A4 inhibitors (e.g., diltiazem):

  • Reduce dose to half of original level 1
  • Starting dose: 20 mg per day 1
  • Maximum dose: 80 mg per day 1

Concomitant use with moderate CYP3A4 inducers:

  • May require dose increase 1

Contraindications

Latuda is absolutely contraindicated in three situations:

  1. Known hypersensitivity to lurasidone or any formulation components 1
  2. Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole) 1
  3. Concomitant use with strong CYP3A4 inducers (e.g., rifampin) 1

Monitoring Parameters

Baseline Assessment

Before initiating Latuda, obtain:

  • Body mass index and waist circumference 4
  • Blood pressure 4
  • Fasting glucose 4
  • Fasting lipid panel 4
  • Complete blood count if patient has pre-existing low WBC or history of leukopenia/neutropenia 1

Ongoing Monitoring

Follow-up metabolic monitoring schedule:

  • BMI: Monthly for 3 months, then quarterly 5
  • Blood pressure, fasting glucose, and lipids: At 3 months, then yearly 5
  • Monitor for extrapyramidal symptoms, akathisia, and parkinsonism at each visit 2, 6
  • Monitor prolactin levels if clinical symptoms suggest hyperprolactinemia 1
  • Perform CBC monitoring in patients with pre-existing low WBC 1

Safety Considerations and Warnings

Black Box Warnings

Two critical black box warnings apply to Latuda:

  1. Increased mortality in elderly patients with dementia-related psychosis - Latuda is not approved for dementia-related psychosis 1

  2. Suicidal thoughts and behaviors - Antidepressants (including when used for bipolar depression) increase risk of suicidal thoughts in pediatric and young adult patients; close monitoring for clinical worsening and emergence of suicidal thoughts is mandatory 1

Common Adverse Effects

In adults with bipolar depression (incidence ≥5% and twice placebo rate):

  • Akathisia 1
  • Extrapyramidal symptoms 1
  • Somnolence 1

In pediatric patients (10-17 years) with bipolar depression:

  • Nausea 1
  • Weight increase 1
  • Insomnia 1

In schizophrenia patients:

  • Somnolence 2
  • Akathisia 2
  • Nausea 2
  • Parkinsonism 2

Metabolic Profile

Latuda demonstrates a highly favorable metabolic profile compared to other atypical antipsychotics:

  • Minimal weight gain 2, 6, 3
  • No clinically meaningful alterations in glucose 2, 3
  • No clinically meaningful alterations in lipids 2, 3
  • Minimal effects on prolactin levels 7, 3

Serious Adverse Events to Monitor

Cerebrovascular adverse reactions:

  • Increased incidence of stroke and transient ischemic attack in elderly patients with dementia-related psychosis 1

Neuroleptic malignant syndrome:

  • Manage with immediate discontinuation and close monitoring 1

Tardive dyskinesia:

  • Discontinue if clinically appropriate 1

Orthostatic hypotension and syncope:

  • Monitor heart rate and blood pressure, especially in patients with cardiovascular or cerebrovascular disease 1

Leukopenia, neutropenia, and agranulocytosis:

  • Consider discontinuing if clinically significant WBC decline occurs without other causative factors 1

Hyperprolactinemia:

  • Prolactin elevations may occur 1, 6

Clinical Efficacy

Latuda demonstrates efficacy across multiple symptom domains:

For schizophrenia:

  • Effective in treating acute phase symptoms 7
  • Reduces risk of relapse in long-term treatment 7
  • Improves positive and negative symptoms 3
  • Mean PANSS total score reduction of -11.8 at 6 months and -15.3 at 12 months in adolescents and young adults 3

For depressive symptoms in schizophrenia:

  • Significantly greater decrease in MADRS score (-2.8) compared to placebo (-1.4), with effect size 0.24 8
  • Among patients with baseline MADRS ≥12, remission achieved in 45.0% of lurasidone-treated patients versus 36.3% on placebo 8

For bipolar depression:

  • Effective dose range 20-120 mg/day 6
  • Exhibits both antipsychotic and antidepressant action 6

Common Pitfalls to Avoid

Administration without food:

  • Failure to take Latuda with at least 350 calories substantially reduces absorption and therapeutic efficacy 1

Combining with contraindicated medications:

  • Never combine with strong CYP3A4 inhibitors or inducers 1

Inadequate monitoring:

  • Baseline metabolic monitoring is essential despite favorable metabolic profile 4
  • Regular monitoring for extrapyramidal symptoms is necessary given higher rates compared to some other atypicals 6

Premature discontinuation:

  • In long-term studies, 68% of patients completed 12 months of treatment, with only 8.2% discontinuing due to adverse events 3

Use as first-line monotherapy in children and adolescents:

  • The American Academy of Child and Adolescent Psychiatry recommends combination of psychopharmacological agents plus psychosocial interventions rather than antipsychotic monotherapy 4

Assuming efficacy for all bipolar phases:

  • Long-term maintenance data remain limited; efficacy should not be assumed for all phases of bipolar disorder 4

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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