Latuda Patient Counseling Information

Advise the patient to read the patient labeling (Medication Guide).
Suicidal Thoughts and Behavior: Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions].
Neuroleptic Malignant Syndrome: Counsel patients about a potentially fatal adverse reaction referred to as Neuroleptic Malignant Syndrome (NMS). Advise patients, family members, or caregivers to contact healthcare provider or to report to the emergency room if they experience signs and symptoms of NMS [see Precautions].
Tardive Dyskinesia: Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Precautions].
Metabolic Changes: Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Precautions].
Hyperprolactinemia: Counsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of LATUDA. Advise them to seek medical attention if they experience any of the following: amenorrhea or galactorrhea in females, erectile dysfunction or gynecomastia in males [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].
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].
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 Potential for Cognitive and Motor Impairment under Precautions].
Heat Exposure and Dehydration: Educate patients regarding appropriate care in avoiding overheating and dehydration [see Body Temperature Dysregulation under Precautions].
Activation of Mania or Hypomania: Advise patients and their caregivers to observe for signs of activation of mania/hypomania [see Precautions].
Concomitant Medication: Advise 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 [see Interactions].
Pregnancy: Advise patients that LATUDA may cause extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients to notify their healthcare provider with a known or suspected pregnancy [see Use in Pregnancy & Lactation].