IMPORTANT INFORMATION ABOUT ABILIFY
2, 5, 10, 15, 20, 30 mg Tablets
This summary of the Package Insert contains risk and safety information for patients about ABILIF Y. Tell your healthcare provider:
This summary does not include all information about ABILIFY and does not take the place of
discussions with your healthcare professional about your treatment. Please read this important
information before you start taking ABILIFY and discuss any questions about ABILIFY with your
healthcare professional.
Name
ABILIFY® (aripiprazole) (air-r˘ı-PIP-ra-zall)
What should I avoid when taking ABILIFY (aripiprazole)?
What is ABILIFY?
ABILIFY (aripiprazole) is a prescription medicine used for treatment of adult patients with manic or
mixed episodes associated with Bipolar I Disorder.
What is Bipolar I Disorder?
Bipolar I Disorder is an illness with symptoms thought to be caused by an imbalance of brain
chemicals. People who have Bipolar I Disorder tend to experience extreme mood swings, along What are the possible side effects of ABILIFY?
with other specific symptoms and behaviors. These mood swings, or “episodes,” can take three
Common side effects in adults include: nausea, vomiting, constipation, headache, dizziness, an
forms: manic, depressive, or mixed episodes. Common symptoms of a manic episode are: feeling
inner sense of restlessness or need to move (akathisia), anxiety and insomnia.
extremely happy, being very irritable and anxious, talking too fast and too much, and having more
It is important to contact your healthcare professional if you experience prolonged, abnormal
energy and needing less sleep than usual. Common symptoms of a depressive episode include:
muscle spasm or contraction which may be signs of a condition called dystonia.
feelings of overwhelming sadness or emptiness, low energy, a loss of interest in things, trouble
concentrating, changes in sleep or appetite, and thoughts of dying or suicide. A mixed episode What percentage of people stopped taking ABILIFY due to side
includes symptoms that are both manic and depressive. effects?
Who should NOT take ABILIFY? In clinical trials, the percentage of adults who discontinued taking ABILIFY due to side effects was
People who are allergic to ABILIFY or to any substance that is in it. Allergic reactions have ranged ABILIFY (11%) and for patients treated with sugar pill (9%).
from rash, hives and itching to difficulty breathing and swelling of the face, lips, or tongue. Please
Can I safely take ABILIFY while I’m taking other medications?
talk with your healthcare professional.
ABILIF Y can be taken with most drugs; however, taking ABILIFY with some medicines may require
What is the most important information that I should know about
your healthcare professional to adjust the dosage of ABILIFY.
ABILIFY?
Some medicines include:
Elderly patients, diagnosed with psychosis as a result of dementia (for example, an inability
®
to perform daily activities as a result of increased memory loss), and who are treated with
)
antipsychotic medicines including ABILIFY, are at an increased risk of death when ®)
compared to patients who are treated with a placebo (sugar pill). ABILIFY is not approved ®)
for the treatment of patients with dementia-related psychosis.
)
®
Some medicines can increase suicidal thoughts and behaviors in children, teens, and young
®)
adults. Serious mental illnesses are themselves associated with an increase in the risk of
suicide. When taking ABILIFY call your doctor right away if you have new or worsening
mood symptoms, unusual changes in behavior, or thoughts of suicide. Patients and their be sure.
caregivers should be especially observant within the first few months of treatment or after
General advice about ABILIFY:
a change in dose.
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:
Stroke or ministroke in elderly patients with dementia: An increased
risk of stroke and ministroke has been reported in clinical studies of elderly patients with ABILIFY Oral Solution contains
dementia (for example, increased memory loss and inability to perform daily activities). ABILIFY sugar
is not approved for treating patients with dementia.
Neuroleptic malignant syndrome (NMS): Very high fever, rigid muscles, ABILIFY DISCMELT® contains phenylalanine
shaking, confusion, sweating, or increased heart rate and blood pressure may be signs of NMS,
a rare but serious side effect that could be fatal.
Find out more about ABILIFY:
Tardive dyskinesia (TD): Abnormal or uncontrollable movements of face, tongue, or
other parts of body may be signs of a serious condition known as TD, which may be permanent.
Additional information can be found at www.abilify.com/bipolardisorder
High blood sugar and diabetes: Patients with diabetes and those having risk
factors for diabetes (for example, obesity, family history of diabetes), as well as those with
symptoms such as unexpected increases in thirst, urination, or hunger should have their blood
sugar levels checked before and during treatment. Increases in blood sugar levels
(hyperglycemia), in some cases serious and associated with coma or death, have been reported
in patients taking ABILIF Y, and medicines like it.
Based on Full Prescribing Information as of 05/08 1239550A2.
Orthostatic hypotension: Lightheadedness or faintness caused by a sudden change
in heart rate and blood pressure when rising too quickly from a sitting or lying position
(orthostatic hypotension) has been reported with ABILIFY.
Suicidal thoughts: If you have suicidal thoughts, you should tell your healthcare
professional right away.
Dysphagia: Medicines like ABILIFY have been associated with swallowing problems
(dysphagia). If you had or have swallowing problems, you should tell your healthcare
professional.
What should I talk to my healthcare provider about?
Patients and their families or caregivers should watch for new or worsening mood symptoms,
unusual changes in behavior and thoughts of suicide, as well as for anxiety, agitation, panic
attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or
extreme hyperactivity. Call your healthcare provider right away if you have thoughts of suicide or
if any of these symptoms are severe or occur suddenly. Be especially observant within the first few
months of antidepressant treatment or whenever there is a change in dose.
