IMPORTANT INFORMATION ABOUT AB1LIFY (aripiprazole)
ABILIFY®
(a
BILTfi)
IJLONLY
(aripiprazole)
This summary of the Medication Guide 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.
What is the most important information I should know
about ABILIFY?
Serious side effects may happen when you take ABILIFY,
including:
• Increased
risk of death
in
elderly
patients with
dementia-related psychosis:
Medicines like ABILIFY can raise the risk of death in elderly
people who have lost touch with reality (psychosis) due to
confusion and memory loss (dementia). ABILIFY is not
approved
for
the
treatment
of
patients
with
dementia-related psychosis.
• Risk of suicidal thoughts or actions: Antidepressant
medicines, depression
and
other serious
mental
illnesses, and suicidal thoughts or actions:
Antidepressant medicines may increase suicidal thoughts
or actions in some children, teenagers, and young adults
within the first few months of treatment. Depression and
other serious mental illnesses are the most important
causes of suicidal thoughts and actions. Some people may
have a particularly high risk of having suicidal thoughts or
actions including people who have (or have a family history
of) bipolar illness (also called manic-depressive illness) or
suicidal thoughts or actions.
How can I
watch for and try to prevent suicidal
thoughts and actions in myself or a family member?
• Pay close attention to any changes, especially sudden
changes, in mood, behaviors, thoughts, or feelings. This is
very important when an antidepressant medicine is
started or when the dose is changed.
• Call the healthcare provider right away to report new or
sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as
scheduled. Call the healthcare provider between visits as
needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you or your family
member has any of the following symptoms, especially if
they are new, worse, or worry you:
•thoughts about suicide or dying, attempts to commit
suicide, new or worse depression, new or worse anxiety,
feeling very agitated or restless, panic attacks, trouble
sleeping (insomnia), new or worse irritability, acting
aggressive, being angry, or violent, acting on dangerous
impulses, an extreme increase in activity and talking
(mania), other unusual changes in behavior or mood.
What else do I need to know about antidepressant
medicines?
•Never stop an antidepressant medicine without first
talking to a healthcare provider.
Stopping an antidepressant
medicine suddenly can cause other symptoms.
• Antidepressants
are
medicines
used
to
treat
depression and other illnesses.
It is important to discuss
all the risks of treating depression and also the risks of not
treating it. Patients and their families or other caregivers
should discuss all treatment choices with the healthcare
provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects.
Talk
to the healthcare provider about the side effects of the
medicine prescribed for you or your family member.
•Antidepressant medicines can
interact with other
medicines.
Know all of the medicines that you or your
family member takes. Keep a list of all medicines to show
the healthcare provider. Do not start new medicines without
first checking with your healthcare provider.
• Not all
antidepressant
medicines
prescribed
for
children are FDA approved for use in children.
Talk to
your child’s healthcare provider for more information.
What is ABILIFY (aripiprazole)?
ABILIFY is a prescription medicine used to treat:
•m a jo r depressive disorder in adults, as
an
add-on
treatment to an antidepressant medicine when you do not
get better with an antidepressant alone.
The symptoms of major depressive
disorder (MDD)
include
feeling of sadness and emptiness, loss of interest in
activities that you once enjoyed and loss of energy, problems
focusing and making decisions, feeling of worthlessness or
guilt, changes in sleep or eating patterns, and thoughts of
death or suicide.
What should I tell my healthcare provider before taking
ABILIFY?
Before taking ABILIFY, tell your healthcare provider if you have
or had:
• diabetes or high blood sugar in you or your family: your
healthcare provider should check your blood sugar before
you start ABILIFY and also during therapy.
• seizures (convulsions).
• low or high blood pressure.
• heart problems or stroke.
• pregnancy or plans to become pregnant. It is not known if
ABILIFY will harm your unborn baby.
• breast-feeding or plans to breast-feed. It is not known if
ABILIFY will pass into your breast milk. You and your
healthcare provider should decide if you will take ABILIFY or
breast-feed. You should not do both.
• low white blood cell count.
• phenylketonuria. ABILIFY DISCMELT Orally Disintegrating
Tablets contain phenylalanine.
• any other medical conditions.
Tell your healthcare provider about all the medicines that
you take or recently have taken,
including prescription
medicines, non-prescription medicines, herbal supplements,
and vitamins.
ABILIFY and other medicines may affect each other causing
possible serious side effects. ABILIFY may affect the way
other medicines work, and other medicines may affect how
ABILIFY works.
Your healthcare provider can tell you if it is safe to take
ABILIFY with your other medicines. Do not start or stop any
medicines while taking ABILIFY without talking to your
healthcare provider first. Know the medicines you take. Keep
a list of your medicines to show your healthcare provider and
pharmacist when you get a new medicine.
How should I take ABILIFY?
• Take ABILIFY exactly as your healthcare provider tells you to
take it. Do not change the dose or stop taking ABILIFY
yourself.
• ABILIFY can be taken with or without food.
• ABILIFY tablets should be swallowed whole.
• If you miss a dose of ABILIFY, take the missed dose as
soon as you remember. If it is almost time for the next
dose, just skip the missed dose and take your next dose
at the regular time. Do not take two doses of ABILIFY at the
same time.
• If you take too much ABILIFY, call your healthcare provider
or poison control center at 1-800-222-1222 right away, or
go to the nearest hospital emergency room.
What should I avoid while taking ABILIFY?
• Do not drive, operate heavy machinery, or do other
dangerous activities until you know how ABILIFY affects
you. ABILIFY may make you drowsy.
• Do not drink alcohol while taking ABILIFY.
• Avoid getting over-heated or dehydrated.
• Do not over-exercise.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun. Do not wear too much or heavy
clothing.
• Drink plenty of water.
What
are
the
possible
side
effects
of
ABILIFY
(aripiprazole)?
Serious side effects have been reported with ABILIFY
including:
• Neuroleptic
malignant syndrome
(NMS):
Tell your
healthcare provider right away if you have some or all of the
following symptoms: high fever, stiff muscles, confusion,
sweating, changes in pulse, heart rate, and blood pressure.
These may be symptoms of a rare and serious condition
that can lead to death. Call your healthcare provider right
away if you have any of these symptoms.
• High blood sugar (hyperglycemia):
Increases in blood
sugar can happen in some people who take ABILIFY.
Extremely high blood sugar can lead to coma or death. If
you have diabetes or risk factors for diabetes (such as
being overweight or a family history of diabetes), your
healthcare provider should check your blood sugar before
you start ABILIFY and during therapy.
Call your healthcare provider if you have any of these
symptoms of high blood sugar while taking ABILIFY:
• feel very thirsty, need to urinate more than usual, feel very
hungry, feel weak or tired, feel sick to your stomach, feel
confused, or your breath smells fruity.
• Difficulty swallowing:
may lead to aspiration and choking.
• Tardive dyskinesia:
Call your healthcare provider about
any movements you cannot control in your face, tongue, or
other body parts. These may be signs of a serious condition.
Tardive dyskinesia may not go away, even if you stop taking
ABILIFY. Tardive dyskinesia may also start after you stop
taking ABILIFY.
• Orthostatic hypotension (decreased blood pressure):
lightheadedness or fainting when rising too quickly from a
sitting or lying position.
• Low white blood cell count
• Seizures (convulsions)
Common side effects with ABILIFY in adults include
nausea, inner sense of restlessness/need to move (akathisia),
vomiting,
anxiety,
constipation,
insomnia,
headache,
restlessness, dizziness.
These are not all the possible side effects of ABILIFY. For more
information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You
may report side effects to FDA at 1-800-FDA-1088.
General information about ABILIFY
• Store ABILIFY at room temperature, between 59°F to 86°F.
Opened bottles of ABILIFY Oral Solution can be used for up
to 6 months after opening, but not beyond the expiration
date on the bottle. Keep ABILIFY and all medicines out of
the reach of children.
• Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use ABILIFY
for a condition for which it was not prescribed. Do not give
ABILIFY to other people, even if they have the same
condition. It may harm them.
• This summary contains the most important information
about ABILIFY. If you would like more information, talk with
your healthcare provider.
For more information about
ABILIFY visit www.abilify.com.
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
ABILIFY is a trademark of Otsuka Pharmaceutical Company.
Bristol-Myers Squibb
Otsuka
Otsuka America Pharmaceutical, Inc.
1239550A9
0310L-1020
D6-B0001D-12-10-MDD
570US08CBS01604
Rev December 2010
© 2010, Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan
