W o rld Mi*
ABILIFY
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IMPORTANT INFORMATION ABOUT ABILIFY
(aripiprazoie)
2,5,10,15,2 0.3D mg Tflblm
This summary of the Package Insert contains risk and safety
information for patients about ABILIFY. This summary does
not include all information about ABIUFY 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
ABIUFY and discuss any questions about ABILIFY with your
healthcare professional.
N a m e
ABIUFY'
[mBIL-T-fi) (ortpiprozole) (aim-PlP-ra-iulL
What is ABILIFY (aripiprazoie)?
ABIUFY 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 1
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 fake 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
fs
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 treatm ent of
patients with dementia-related psychosis.
Seme medicines can
increase suicidal thoughts and
behaviors in children, teens, and young adults. Serious
mental
Illnesses
are
themselves
associated
w ith
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), ABIUFY is not
approved for treating patients with dementia.
Neuroleptic
malignant
syndrome
(NM$);
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
(T O ): 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
ABILITY
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,
imputsivity,
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 1
avoid when taking ABILIFY
(aripiprazoie}?
* Avoid overheating and dehydration
* Avoid driving or operating hazardous machinery until you
know how ABIUFY affects you
* Avoid drinking alcohol
* Avoid breast-feeding an infant
What
are
the
possible
side
effects
of
ABIUFY?
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,
extra pyramidal
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.abilifv.cam. Talk to your healthcare
professional if you
have questions or develop
any side
effects.
What
percentage of people
stopped
taking
ABILIFY (aripiprazoie) 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 ABIUFY 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 ABIUFY due
to
side
effects was 7% and 2% for patients treated with sugar pill.
Can I safety 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 (QUJNfDEX®)
• 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 ABIUFY
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
ABIUFY
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
w w w .abilifyxom /bipolardisorder
■ NIZORAL
is a registered
trademark
of Janssen
Pharmaceutics; QU
iN
iDEX
is a
registered
trademark
of Wyeth
Pharmaceuticals: PROZAC
is a registered
trademark
of E
li Lilly
and
Company: PAXIL
is a registered
trademark
of
GlaxoSm
ithKline;
TEGRETOL
is
a
registered
trademark
of
Novartis
Pharmaceuticals.
Based on Full Prescribing Information as of
1
l/dS
1239550
A
7
.
Bristol-Myers Squibb
Q l S L J k f]
Olsifta America Pharraareuriul. Int.
Tablets manufactured
by Otscka 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.
Oistribated
and
marketed
by (Malta America Pharmaceutical. Inc.
.
Rockvifle, IVSD
20650
USA.
Marketed by Bristol-Myers Squibb Company, Princeton. NJ
08543
USA.
U.S. Patent Nos.
5
.
006
,
528
;
6
,
977
,
257
;
and
7
,
115
,
537
.
0 2 0 0 9
Otsuka America Pharmaceutical. Inc., Rockville, MD
570US03CBS01904 0309L-2755 D6-B0001D-11-09-BD November 2009
