Physicians are advised to discuss with patients for whom they prescribe LATUDA all relevant safety information including, but not limited to, the following: Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Advise patients and caregivers that elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. LATUDA is not approved for elderly patients with dementia-related psychosis (see Precautions).
Neuroleptic Malignant Syndrome: Advise patients and caregivers that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) (see Precautions).
Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain): Educate patients and caregivers about the risk of metabolic changes and the need for specific monitoring. The risks include hyperglycemia and diabetes mellitus, dyslipidemia, weight gain, and cardiovascular reactions. Educate patients and caregivers about the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus (e.g., polydipsia, polyuria, polyphagia, and weakness). Monitor all patients for these symptoms. Patients who are diagnosed with diabetes or have risk factors for diabetes (obesity, family history of diabetes) should have their fasting blood glucose monitored before beginning treatment and periodically during treatment. Patients who develop symptoms of hyperglycemia should have assessments of fasting glucose. Clinical monitoring of weight is recommended (see Precautions).
Orthostatic Hypotension: Educate patients about the risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose (see Precautions).
Leukopenia/Neutropenia: Advise patients with a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia that they should have their CBC monitored while taking LATUDA (see Precautions).
Interference with Cognitive and Motor Performance: Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that LATUDA therapy does not affect them adversely (see Precautions).
Pregnancy and Nursing: Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy with LATUDA (see Use in Pregnancy & Lactation).
Concomitant Medication and Alcohol: Instruct patients to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, because there is a potential for drug interactions. Advise patients to avoid alcohol while taking LATUDA (see Interactions).
Heat Exposure and Dehydration: Educate patients regarding appropriate care in avoiding overheating and dehydration (see Precautions).