Irritability Associated with Autistic Disorder (Ages 6 to 17).

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

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 antipsychotic medicines including ABILIFY, 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 provider 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, and swelling of the mouth, face, lips, or tongue.

Serious side effects may include:

• An increased risk of stroke and ministroke have been reported in clinical studies of elderly people with dementia-related psychosis
• High fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure may be signs of a condition called
  neuroleptic malignant syndrome (NMS), a rare and serious condition that can lead to death
• Increases in blood sugar levels (hyperglycemia) can happen in some people who take ABILIFY. Extremely high blood sugar can lead to coma or death. If you have diabetes, or risk factors (for example, obesity, family history of diabetes), or have the following symptoms: increases in thirst, urination, or hunger, feel weak or tired, sick to your stomach, or confused (or breath smells fruity), your blood sugar should be monitored
• Changes in cholesterol and triglyceride (fat, also called lipids) levels in the blood have been seen in patients taking medicines like ABILIFY
• Weight gain has been reported in patients taking medicines like ABILIFY so your weight should be checked regularly. Weight gain in children (ages 6 to 17) should be compared against that expected with normal growth
• ABILIFY and medicines like it have been associated with difficulty swallowing which may lead to aspiration or choking
• Uncontrollable movements of face, tongue, or other parts of body, as these may be signs of a serious condition called tardive dyskinesia (TD). TD may not go away, even if you stop taking ABILIFY. TD may also start after you stop taking ABILIFY
• Orthostatic hypotension (decreased blood pressure) or lightheadedness or fainting when rising too quickly from a sitting or lying position has been reported with ABILIFY
• Decreases in white blood cells (WBC; infection fighting cells) have been reported in some patients taking ABILIFY. Patients with a history of a significant decrease in WBC count or who have experienced a low WBC count due to drug therapy should have their blood tested and monitored during the first few months of therapy
• Seizures (convulsions) have been reported with ABILIFY. Tell your healthcare provider if you have a history of or are at risk for seizures
• ABILIFY and medicines like it can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you
• Medicines like ABILIFY can impact your body’s ability to reduce body temperature; you should avoid overheating and dehydration
• Tell your healthcare provider if you are pregnant or intend to become pregnant. Also tell your healthcare provider about any other medical conditions you have and about all prescription and non-prescription medicines you are taking or plan to take since there are some risks for drug interactions

While taking ABILIFY, avoid:

• Drinking alcohol
• Breast-feeding an infant

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

• ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety, insomnia, and restlessness
• PEDIATRIC PATIENTS (6 to 17 years): Sleepiness, headache, vomiting, extrapyramidal disorder (for example, uncontrolled movement disorders or muscle disturbances such as restlessness, tremors, and muscle stiffness), fatigue, increased appetite, insomnia, nausea, stuffy nose, and weight gain

It is important to contact your healthcare provider if you experience prolonged, abnormal muscle spasms or contractions, 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 provider.

INDICATIONS: ABILIFY is indicated for:

• Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy
• Treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17 years of age
• Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age
• Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age

Special Considerations for Pediatric Uses:

• Discuss the risks and benefits of treatment with your child’s healthcare provider. Treatment should be started only after a thorough diagnostic evaluation and as part of a total treatment program

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