LATUDA® (lurasidone HCl) Tablets

---------------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-naïve 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 (5.12).  See Full Prescribing Information for additional WARNINGS and PRECAUTIONS