ABILIFY (aripiprazole) is used for the treatment of manic and mixed episodes associated with bipolar I disorder in adults
and in pediatric patients 10 to 17 years of age. It can be used either by itself or as an add-on treatment to lithium or valproate.
Important Warning About Elderly Patients With Dementia-Related Psychosis:
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 (aripiprazole), are at an increased
risk of death compared to placebo. ABILIFY is not approved for the treatment of people with
Please see IMPORTANT SAFETY INFORMATION on pages 2-3 and U.S. FULL PRESCRIBING INFORMATION,
including Boxed WARNINGS, and Medication Guide at ABILIFY.com.
September 2013 03US13EC0026
IMPORTANT SAFETY INFORMATION 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
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-
- 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
- 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
- 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
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
IMPORTANT SAFETY INFORMATION continued on next page.
September 2013 03US13EC0026
IMPORTANT SAFETY INFORMATION (continued) and INDICATION for ABILIFY® (aripiprazole)
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 with phenylketonuria or PKU, ABILIFY DISCMELT® (aripiprazole) contains phenylalanine.
If you have any questions about your health or medicines, talk to your healthcare provider.
INDICATION: ABILIFY is indicated for:
- Treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17
years of age, and as an adjunct to lithium or valproate
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 at ABILIFY.com.