Drug Name: LATUDA (Brand Name Drug)
Active Ingredient: LURASIDONE HYDROCHLORIDE
FDA Application No.: (NDA) 200603
Company: Sunovion Pharma, Inc.
Original Approval Date FDA: October 28, 2010
Strength: 40MG, 80MG
Dosage form/route: Tablet; Oral
Marketing Status: Prescription
Highlights of prescribing information
These highlights do not Include all the Information needed to use Latuda safely and effectively. See full prescribing Information (FPI) for Latuda.
Latuda (Lurasidone HCL) tablets for oral administration
Warning: increased mortality in elderly patients with dementia-related psychosis
See full prescribing information for complete boxed warning.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Latuda is not approved for the treatment of patients with dementia-related psychosis. (5.1)
Indications and usage
Latuda is an atypical antipsychotic agent indicated for the treatment of patients with schizophrenia (1). Efficacy was established in four 6-week controlled studies of adult patients with schizophrenia (14.1).
Dosage and administration
The recommended starting dose of Latuda is 40 mg once daily. Initial dose titration is not required. The maximum recommended dose is 80 mg once daily. Latuda should be taken with food (2.2).
Dosage forms and strengths
Tablets: 40 mg and 80 mg (3)
Any known hypersensitivity to Latuda or any components in the formulation (4). Coadministration with a strong CYP3A4 inhibitor (e.g., ketoconazole) and inducer (e.g.,rifampin) (4).
Warnings and precautions
• Cerebrovascular Adverse Reactions: An increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs. (5.2)
• Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.3).
• Tardive Dyskinesia: Discontinue if clinically appropriate (5.4).
• Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain (5.5).
• Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes.
• Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.
• Weight Gain: Gain in body weight has been observed, clinical monitoring of weight is recommended.
• Hyperprolactinemia: Prolactin elevations may occur (5.6).
• Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and Latuda should be discontinued at the first sign of a decline in WBC in the absence of other causative factors (5.7).
• Orthostatic Hypotension and Syncope: Dizziness, tachycardia or bradycardia, and syncope may occur, especially early in treatment. Use with caution in patients with known cardiovascular or cerebrovascular disease, and in antipsychotic-naїve patients (5.8).
• Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold (5.9).
• Potential for Cognitive and Motor Impairment: Use caution when operating machinery (5.10).
• Suicide: The possibility of a suicide attempt is inherent in schizophrenia. Closely supervise high-risk patients (512).
• See Full Prescribing Information for additional Warnings and Precautions
Commonly observed adverse reactions (incidence ≥5% and at least twice the rate for placebo) included somnolence, akathisia, nausea, parkinsonism and agitation (6.2).
To report suspected adverse reactions, contact Sunovion Pharmaceuticals Inc. at 877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• Latuda is not recommended to be used in combination with strong CYP3A4 inhibitors, e.g., ketoconazole. (4 and 7.1)
• Dose adjustment is recommended for moderate CYP3A4 inhibitors (e.g. diltiazem) (7.1)
• Latuda is not recommended to be used in combination with strong CYP3A4 inducers, e.g., rifampin. (4 and 7.1)
Use in specific populations
• Geriatric Use: No dose adjustments required. (8.5)
• Pregnancy: Use Latuda during pregnancy only if the potential benefit justifies the potential risk. (8.1)
• Nursing Mothers: Breast feeding is not recommended. (8.3)
• Pediatric Use: Safety and effectiveness have not been established. (8.4)
• Renal Impairment: Dose adjustment is recommended. (8.6)
• Hepatic Impairment: Dose adjustment is recommended. (8.7)
Full prescribing information: contents*
Increased mortality in elderly patients with dementia-related psychosis
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
2.2 Administration Instructions
2.3 Dosage in Special Populations
3. DOSAGE FORMS AND STRENGTHS
5. WARNINGS AND PRECAUTIONS
5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis
5.2 Cerebrovascular Adverse Reactions, Including Stroke
5.3 Neuroleptic Malignant Syndrome
5.4 Tardive Dyskinesia
5.5 Metabolic Changes
5.7 Leukopenia, Neutropenia and Agranulocytosis
5.8 Orthostatic Hypotension and Syncope
5.10 Potential for Cognitive and Motor Impairment
5.11 Body Temperature Regulation
5.14 Use in Patients With Concomitant Illness
6. ADVERSE REACTIONS
6.1 Overall Adverse Reaction Profile
6.2 Clinical Studies Experience
6.3 Dose-Related Adverse Reactions
6.4 Extrapyramidal Symptoms
6.5 Laboratory Test Abnormalities and ECG Changes in Clinical Studies
6.6 Other Adverse Reactions Observed During the Premarketing Evaluation of Latuda
7. DRUG INTERACTIONS
7.1 Potential for Other Drugs to Affect Latuda
7.2 Potential for Latuda to Affect Other Drugs
8. USE IN SPECIFIC POPULATIONS
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
8.10 Smoking Status
9. DRUG ABUSE AND DEPENDENCE
9.1 Controlled substance
10.1 Human Experience
10.2 Management of Overdosage
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13. NONCLINICAL TOXICOLOGY
14. CLINICAL STUDIES
16. HOW SUPPLIED/STORAGE AND HANDLING
17. PATIENT COUNSELING INFORMATION
17.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis
17.2 Neuroleptic Malignant Syndrome
17.3 Hyperglycemia and Diabetes Mellitus
17.4 Orthostatic Hypotension
17.6 Interference with Congnitive and Motor Performance
17.7 Pregnancy and Nursing
17.8 Concomitant Medication and Alcohol
17.9 Heat Exposure and Dehydration
*Sections or subsections omitted from the full prescribing information are not listed