Abilify Patient Counseling Information

Physicians are advised to discuss the following issues with patients for whom they prescribe ABILIFY: 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].
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with antipsychotic drugs are at increased risk of death. ABILIFY is not approved for elderly patients with dementia-related psychosis [see Use in Elderly Patients with Dementia-Related Psychosis under Precautions].
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 behavior, 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 behavior and indicate a need for very close monitoring and possibly changes in the medication [see Clinical Worsening of Depression and Suicide Risk 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. A patient Medication Guide including information about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for ABILIFY. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. It should be noted that ABILIFY is not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder.
Use of Orally Disintegrating Tablet: Do not open the blister until ready to administer. For single tablet removal, open the package and peel back the foil on the blister to expose the tablet. Do not push the tablet through the foil because this could damage the tablet. Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT Orally Disintegrating Tablet on the tongue. Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid. Do not attempt to split the tablet.
Interference with Cognitive and Motor Performance: Because aripiprazole 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 aripiprazole therapy does not affect them adversely [see Potential for Cognitive and Motor Impairment under Precautions].
Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with ABILIFY [see Pregnancy under Use in Pregnancy & Lactation].
Nursing: Patients should be advised not to breast-feed an infant if they are taking ABILIFY [see Nursing Mothers under Use in Pregnancy & Lactation].
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 [see Potential for ABILIFY to Affect Other Drugs under Interactions].
Heat Exposure and Dehydration: Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Body Temperature Regulation under Precautions].
Phenylketonurics: Phenylalanine is a component of aspartame. Each ABILIFY DISCMELT Orally Disintegrating Tablet contains the following amounts: 10 mg - 1.12 mg phenylalanine and 15 mg - 1.68 mg phenylalanine.