Discuss the following issues with patients prescribed ABILIFY: Clinical Worsening of Depression and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behaviour, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behaviour and indicate a need for very close monitoring and possibly changes in the medication [see Suicidal Thoughts and Behaviours in Children, Adolescents, and Young Adults under Precautions].
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with ABILIFY and should counsel them in its appropriate use.
Pathological Gambling and Other Compulsive Behaviours: 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 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 Behaviours under Precautions].
Interference with Cognitive and Motor Performance: Because ABILIFY may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that ABILIFY therapy does not affect them adversely [see Potential for Cognitive and Motor Impairment under Precautions].
Concomitant Medication: Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Interactions].
Alcohol: Patients should be advised to avoid alcohol while taking ABILIFY.
Heat Exposure and Dehydration: Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Body Temperature Regulation under Precautions].
Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with ABILIFY. Advise patients that ABILIFY may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to ABILIFY during pregnancy [see Pregnancy under Use in Pregnancy & Lactation].
Lactation: Abilify use during pregnancy may affect milk supply. Advise the lactating patient to discuss any plans for breastfeeding with their healthcare provider, and to monitor the breastfed infant for dehydration and lack of appropriate weight gain [see Lactation under Use in Pregnancy & Lactation].
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