IMPORTANT INFORMATION ABOUT ABILIFY
A B IL IF Y
(aripiprazole)
2,5, 10, 15, 20, 30 mg Tablets
This summary of the Package Insert contains risk and safety information for patients about ABILIFY.
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
®
(a-BIL-T-fl)
(aripiprazole) (air-rT-PIP-ra-zall)
What is ABILIFY?
ABILIFY (aripiprazole) is a prescription medicine used as an add-on treatment to antidepressants for
Major Depressive Disorder in adults.
What is depression?
Depression is a common but serious medical condition. Symptoms may include sadness, loss of
interest in activities you once enjoyed, loss of energy, difficulty concentrating or making decisions,
feelings of worthlessness or excessive guilt, insomnia or excessive sleep, a change in appetite
causing weight loss or gain, or thoughts of death or suicide. These could be depression symptoms
if they interfere with daily life at home, at work, or with friends and last most of the day, nearly every
day for at least 2 weeks.
What is the most important information that I should know about anti-
depressant medicines, depression, and other serious mental illnesses?
•
Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers,
and young adults
•
Depression and serious mental illnesses are the most important causes of suicidal thoughts and
actions
For more information, see the Prescribing Information and the Medication Guide called
Antidep
r
essant
Medicines, Dep
r
ession and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions.
Who should NOT take ABILIFY?
People who are allergic to ABILIFY or to any substance that is in it. Allergic reactions have ranged
from rash, hives and itching to difficulty breathing and swelling of the face, lips, or tongue. Please
talk with your healthcare professional.
What is the most important information that I should know about
ABILIFY?
Elderly patients, diagnosed w
ith 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 w
ith
antipsychotic medicines including ABILIFY, are at an increased risk of death when compared
to
patients who are treated w
ith a placebo (sugar pill). ABILIFY is not approved for the
treatment of patients w
ith dementia-related psychosis.
Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers,
and young adults, especially w
ithin the first few
months of treatment or when the dose is
changed. Depression and other serious mental illnesses are themselves associated w
ith an
increase in the risk of suicide. Patients on
antidepressants and their fam
ilies 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 w
ith depression.
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 dementia (for
example, increased memory loss and inability to perform daily activities). ABILIFY is not approved
for treating patients with dementia.
Neuroleptic malignant syndrome (NMS):
Very high fever, rigid muscles,
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.
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.
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 ABILIFY,
and medicines like it.
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 depression
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.
Tell your healthcare provider about any medical conditions you may have and all medicines that you
are taking or plan to take, including prescription and nonprescription (over-the-counter) medicines.
Be sure to tell your healthcare provider:
•
If you have suicidal thoughts
•
If you or anyone in your family have or had seizures
•
If you or anyone in your family have or had high blood sugar or diabetes
•
If you are pregnant, plan to become pregnant, or are breast-feeding
What should I avoid when taking ABILIFY (aripiprazole)?
•
Avoid overheating and dehydration
•
Avoid driving or operating hazardous machinery until you know how ABILIFY affects you
•
Avoid drinking alcohol
•
Avoid breast-feeding an infant
What are the possible side effects of ABILIFY?
Common side effects in adults include: nausea, vomiting, constipation, headache, dizziness, an inner
sense of restlessness or need to move (akathisia), anxiety and insomnia.
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.
What percentage of people stopped taking ABILIFY due to side
effects?
In clinical trials, the percentage of adults who discontinued taking ABILIFY due to side effects was
ABILIFY (6%) and for patients treated with sugar pill (2%).
Can I safely take ABILIFY while I’m
taking other medications?
ABILIFY can be taken with most drugs; however, taking ABILIFY with some medicines may require
your healthcare professional to adjust the dosage of ABILIFY
Some medicines* include:
•
ketoconazole (NIZORAL®)
•
quinidine (QUINIDEX®)
•
fluoxetine (PROZAC®)
•
paroxetine (PAXIL®)
•
carbamazepine (TEGRETOL®)
It is important to tell your healthcare professional about all the medicines you’re taking, just to be sure.
General advice about ABILIFY:
•
ABILIFY is usually taken once a day, with or without food
•
ABILIFY should be kept out of the reach of children and pets
•
Store ABILIFY Tablets and the Oral Solution at room temperature
•
For patients who must limit their sugar intake, be aware that
ABILIFY Oral Solution contains
sugar
•
For patients who cannot metabolize phenylalanine (those with phenylketonuria or PKU),
ABILIFY DISCMELT®
contains phenylalanine
•
If you have additional questions, talk to your healthcare professional
Find out more about ABILIFY:
Additional information can be found at
www
.abilify.com
• NIZORAL is a registered trademark of Janssen Pharmaceutica; QUINIDEX is a registered
trademark of Wyeth Pharmaceuticals; PROZAC is a registered trademark of Eli Lilly and
Company; PAXIL is a registered trademark of GlaxoSmithKline; TEGRETOL is a registered
trademark of Novartis Pharmaceuticals.
Based on Full Prescribing Information as of
05/08
1239550
A
2
.
Ц Ц Bristol-Myers Squibb
^ ^ O t s u k d
Otsuka America Pharmaceutical,Inc.
Tablets manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan or
Bristol-Myers Squibb Company, Princeton, NJ 08543 USA.
Orally Disintegrating Tablets, Oral Solution, and Injection manufactured by
Bristol-Myers Squibb Company, Princeton, NJ 08543 USA.
Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA.
Marketed by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA.
U.S. Patent Nos. 5,006,528; 6,977,257; and 7,115,587.
©2008 Otsuka America Pharmaceutical, Inc., Rockville, MD
570US08CBS01601
0308L-1141
Printed in USA D6-B0001D-05-08-MDD
May 2008
