IMPORTANT SAFETY INFORMATION and INDICATION for ABILIFY^® (aripiprazole)

INDICATIONS: ABILIFY is indicated for:

• Add-on treatment to antidepressants for major depressive disorder in adults
• Acute and maintenance treatment of adults with manic or mixed episodes associated with Bipolar I Disorder
• Acute treatment of pediatric patients 10 to 17 years of age with manic or mixed episodes associated with Bipolar I Disorder
• Treatment of schizophrenia in adults and adolescents 13 to 17 years of age

IMPORTANT SAFETY INFORMATION:
Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with atypical antipsychotic medicines, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis (see Boxed WARNING).

Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient's healthcare professional right away, especially if they are severe or occur suddenly. ABILIFY is not approved for use in pediatric patients with depression (see Boxed WARNING).

CONTRAINDICATION: Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in ABILIFY. Allergic reactions have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue

Serious side effects can occur with any antipsychotic medicine, including ABILIFY. Tell your healthcare professional right away if you have any conditions or side effects, including the following:

• An increased risk of stroke and ministroke has been reported in clinical studies of elderly patients with dementia-related psychosis
• Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal
• Abnormal or uncontrollable movements. These may be signs of a serious condition called tardive dyskinesia (TD), which may be permanent
• Diabetes, risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking ABILIFY and medicines like it. Ask your healthcare professional about the need to monitor your blood sugar level before and during treatment

Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with ABILIFY.

Medicines like ABILIFY can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you.

Since medicines like ABILIFY can impact your body's ability to reduce body temperature, you should avoid overheating and dehydration.

If you have suicidal thoughts, you should tell your healthcare professional right away.

Medicines like ABILIFY have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your healthcare professional.

Tell your healthcare professional if you have a history of seizures, or are pregnant or intend to become pregnant, and about all prescription and non-prescription medicines you are taking or plan to take.

Most common side effects (≥10%) from all clinical trials involving adults or pediatrics include:

ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety and insomnia.

PEDIATRICS (10-17 years): Uncontrolled movements, headache, sleepiness and nausea.

While taking ABILIFY, avoid:

• Drinking alcohol
• Breast-feeding an infant

It is important to contact your healthcare professional if you experience prolonged, abnormal muscle spasm or contraction which may be signs of a condition called dystonia.

For patients who must limit their sugar intake, ABILIFY Oral Solution contains sugar.

For patients with phenylketonuria or PKU, ABILIFY^® DISCMELT™ (aripiprazole) contains phenylalanine.

If you have any questions about your health or medicines, talk to your healthcare professional.

Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide.

ABILIFY and Bipolar I Disorder | ABILIFY and Schizophrenia | ABILIFY as Add-on Therapy for Depression

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