IMPORTANT INFORMATION ABOUT ABILIFY
A B I L I F 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®
(o-BIL-T-fT)
(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 antidepressant 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
Antidepressant Medicines, Depression
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 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.
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 professional right away, especially
if they are severe or occur suddenly. ABILIFY is not
approved for use in pediatric patients with 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
m
inistroke has been reported in
clinical studies of elderly
patients with dementia (for example, increased memory loss
and inability to perform
daily activities). ABILIFY
(aripiprazole)
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 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 over-the-counter medicines, vitam
ins,
or herbal products.
Be sure to tell your healthcare provider:
• If you have suicidal thoughts
• If you have or have had a low
white blood cell count (WBC)
• 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?
• 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 (aripiprazole)?
Common side effects in
adults include: nausea, vom
iting,
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.
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
ABILlFY due to side effects?
In
clinical trials, the percentage of adults who discontinued
taking ABILIFY due to side effects was 6% and
2
% for patients
treated with sugar pill.
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.
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 lim
it 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 Lil y and Company; PAXIL is a registered trademark of GlaxoSmithKline;
TEGRETOL is a registered trademark of Novartis Pharmaceuticals.
Based on Ful Prescribing Information as of 07/09 1239550A5.
Bristol-Myers Squibb
^^Otsuka O
tsuka
America
Pharmaceutical, Inc.
Tablets manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan
or Bristol-Myers Squibb Company, Princeton, NJ 08543 USA.
Oral y Disintegrating Tablets, Oral Solution, and Injection manufactured by
Bristol-Myers Squibb Company, Princeton, NJ 08543 USA.
Distributed and marketed by Otsuka America Pharmaceutical, Inc.,
Rockvil e, 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., Rockvil e, MD
570US08CBS01602
0309L-2322
D6-B0001D-07-09-MDD
July 2009
