Rexulti Patient Counseling Information

Suicidal Thoughts and Behaviors: 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, Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults under Precautions].
Dosage and Administration: Advise patients that REXULTI can be taken with or without food. Advise patients regarding importance of following dosage escalation instructions and adjustment [see Treatment of Schizophrenia, Dosage Adjustments for Hepatic Impairment, Dosage Adjustments for Renal Impairment, Dosage Modifications for CYP2D6 Poor Metabolizers and for Concomitant Use with CYP Inhibitors or Inducers under Dosage & Administration].
Neuroleptic Malignant Syndrome (NMS): Counsel patients about a potentially fatal adverse reaction -Neuroleptic Malignant Syndrome (NMS) that has been reported in association with administration of antipsychotic drugs. Advise patients to contact a health care provider or report to the emergency room if they experience signs or symptoms of NMS [see Neuroleptic Malignant Syndrome (NMS) under Precautions].
Tardive Dyskinesia: Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their health care provider if these abnormal movements occur [see Tardive Dyskinesia under 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 Metabolic Changes under Precautions].
Pathological Gambling and Other Compulsive Behaviors: Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking REXULTI. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped [see Pathological Gambling and Other Compulsive Behaviors under Precautions].
Leukopenia, Neutropenia and Agranulocytosis: 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 REXULTI [see Leukopenia, Neutropenia and Agranulocytosis under Precautions].
Orthostatic Hypotension and Syncope: Educate patients about the risk of orthostatic hypotension and syncope especially early in treatment, and also at times of re-initiating treatment or increases in dosage [see Orthostatic Hypotension and Syncope under Precautions].
Heat Exposure and Dehydration: Counsel patients regarding appropriate care in avoiding overheating and dehydration [see Body Temperature Dysregulation under 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 REXULTI therapy does not adversely affect their ability to engage in such activities [see Potential for Cognitive and Motor Impairment under Precautions].
Concomitant Medications: Advise patients to inform their health care providers of any changes to their current prescription or over-the-counter medications because there is a potential for clinically significant interactions [see Drugs Having Clinically Important Interactions with REXULTI under Interactions].
Pregnancy: Advise patients that third trimester use of REXULTI may cause extrapyramidal and/or withdrawal symptoms in a neonate and to notify their healthcare provider with a known or suspected pregnancy. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REXULTI during pregnancy [see Pregnancy under Use in Pregnancy & Lactation].