IM P O R TA N T IN FO RM A TIO N A B O U T A B IL IF Y
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 is not meant to
take the place of discussions with your healthcare
professional about your treatment. Please read this
important information carefully before you start taking
ABILIFY and discuss any questions about ABILIFY with your
healthcare professional.
Name
ABILIFY® (n-BIL-T-fI) (aripiprazole) (air-rT-PIP-ra-zall)
What is ABILIFY (aripiprazole)?
ABILIFY is a prescription medicine used alone or with lithium
or divalproex to treat manic or mixed episodes of Bipolar I
Disorder in adults or pediatric patients (10 to 17 years).
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 with other specific symptoms and behaviors. These
mood swings, or “episodes,” can take three forms: manic,
depressive, or mixed episodes. Common symptoms of a
manic episode are: feeling extremely happy, being very
irritable and anxious, talking too fast and too much, and
having more energy and needing less sleep than usual.
Common symptoms of a depressive episode include: 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
includes symptoms that are both manic and depressive.
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 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 w ith 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 w ith 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 caregivers should
be especially observant within the first few months of
treatment or after 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 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.
Leukopenia, Neutropenia, and Agranulocytosis:
Decreases in white blood cells (infection fighting cells)
have been reported in some patients taking antipsychotic
agents, including ABILIFY Patients with a history of a
significant decrease in white blood cell (WBC) count or
who have experienced a low WBC due to drug therapy
should have their blood tested and monitored during the
first few months of therapy.
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.
Be sure to tell your healthcare provider:
• About any medical conditions you may have
• Whether you're taking any other prescription or over-the-
counter medicines, vitamins, or herbal products
• Whether you're pregnant, plan to become pregnant, or are
breast-feeding
• If you have or have had a low white blood cell count (WBC)
• If you or anyone in your family has had seizures
• If you or anyone in your family has had high blood sugar
or diabetes
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.
Common side effects in pediatric patients (6 to 17 years)
include: sleepiness, headache, vomiting, extrapyramidal
disorder (for example, uncontrolled movement disorders or
muscle disturbances such as restlessness, tremors and
muscle stiffness), tiredness, increased appetite, insomnia,
nausea, stuffy nose/sore throat, and increased weight.
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.
This is not a complete list of side effects. For full patient
information, visit www.abilify.com. Talk to your healthcare
professional if you have questions or develop any side
effects.
What percentage of people stopped taking
ABILIFY (aripiprazole) due to side effects?
The percentage of adults who discontinued taking ABILIFY
due to side effects compared to those treated with sugar pill
was 11% and 10% in clinical trials of ABILIFY used alone and
12% and 6% in a clinical trial of ABILIFY used with lithium or
divalproex.
In clinical trials, the percentage of pediatric patients (10 to
17 years) who discontinued taking ABILIFY due to side
effects was 7% and 2% for patients treated with sugar pill.
Can I safely take ABlLIFY 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.
How should I take ABILIFY?
• Take ABILIFY exactly as directed by your healthcare
professional
• ABILIFY is usually taken once a day and can be taken with
or without food
• If you miss a dose, take it as soon as you remember.
However, if it is time for your next dose, skip the missed
dose and take only your regularly scheduled dose
• Talk to your healthcare professional before stopping
ABILIFY or changing your dose
General advice about ABILIFY:
• 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/bipolardisorder
• 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 11/09 1239550A7.
Bristo
l-Myers Squ
ibb
OtSLlka O
tsuka
America
Pharmaceu
tica
l,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.
©2009 Otsuka America Pharmaceutical, Inc., Rockville, MD
570US08CBS01904 0309L-2755 D6-B0001D-11-09-BD November 2009
