Abilify Maintena Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (MEDICATION GUIDE).
Pathological Gambling and Other Compulsive Behaviors: Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, increased urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking aripiprazole. 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].
Neuroleptic Malignant Syndrome: Counsel patients about a potentially fatal adverse reaction referred to as NMS that has been reported in association with administration of antipsychotic drugs. Advise patients, family members, or caregivers to contact a health care provider or report to the emergency room if they experience signs and symptoms of NMS [see Neuroleptic Malignant Syndrome under PRECAUTIONS].
Tardive Dyskinesia: Advise patients that abnormal involuntary movements have been associated with the administration of antipsychotic drugs. Counsel patients to notify their health care provider if they notice any movements which they cannot control in their face, tongue, or other body part [see Tardive Dyskinesia under PRECAUTIONS].
Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain): 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].
Orthostatic Hypotension: 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 under PRECAUTIONS].
Leukopenia/Neutropenia: Advise patients with a pre-existing low WBC count or a history of drug-induced leucopenia/neutropenia that they should have their CBC monitored while receiving ABILIFY MAINTENA [see Leukopenia, Neutropenia, and Agranulocytosis under PRECAUTIONS].
Interference with Cognitive and Motor Performance: Because ABILIFY MAINTENA may have the potential to impair judgment, thinking, or motor skills, instruct patients to be cautious about operating hazardous machinery, including automobiles, until they are reasonably certain that ABILIFY MAINTENA therapy does not affect them adversely [see Potential for Cognitive and Motor Impairment under PRECAUTIONS].
Heat Exposure and Dehydration: Advise patients regarding appropriate care in avoiding overheating and dehydration [see Body Temperature Regulation under PRECAUTIONS].
Concomitant Medication: Advise patients to inform their health care providers of any changes to their current prescription or over-the-counter medications since there is a potential for clinically significant interactions (see INTERACTIONS).
Pregnancy: Advise patients that ABILIFY MAINTENA may cause extrapyramidal and/or withdrawal symptoms in a neonate and to notify their healthcare provider with a known or suspected pregnancy [see Pregnancy under USE IN PREGNANCY & LACTATION].