IMPORTANT INFORMATION ABOUT ABILIFY
A B I L I F Y
(aripiprazolc)
2.S. 10. IS.20.20mg Ttbtati
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-n-PIP-ra-zall)
W h at is A B IL IF Y ?
ABILIFY (aripiprazole) is a prescription medicine used as an add-on treatment to
antidepressants for Major Depressive Disorder in adults.
W h at is d e p r e s s io n ?
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.
W hat is th e m o st im p o rta n t in fo rm a tio n th a t I sh o u ld
k n o w
a b o u t a n tid e p r e s s a n t m e d ic in e s , d e p r e s s io n , an d o th e r s e rio u s
m e n ta l illn e s s e s ?
• 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
An
tidepressan
t M
ed
icines, D
epression
and
O
ther Serious M
en
ta
l Illnesses, and
Su
icida
l
Though
ts or Actions.
W ho s h o u ld N O T t a k e A B IL IF Y ?
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.
W h at is t h e m o s t im p o r ta n t in fo rm a tio n t h a t I s h o u ld k n o w
a b o u t A B IL IF Y ?
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:
Stro k e or m in istro ke in elderly p a tie nts w ith dem entia: 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 appruved lor treating patients with dementia.
N e u r o le p tic
m a lig n a n t
s y n d r o m e
(N M S):
Very high fever, rigid
muscles, shaking, confusion, sweating, or increased heart rale and blood pressure may
be signs of NMS, a rare but serious side effect that could be fatal.
T a rd iv e d y s k in e s ia (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
H igh b lo o d s u g a r a n d d ia b e t e s :
Patients with diabetes arid 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 m patients taking ABILIFY. and medicines like it.
O r th o s t a tic h y p o t e n s io n :
I ightheadedness 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.
S u ic id a l
t h o u g h t s :
If you have suicidal thoughts, you should tell your
healthcare professional right away.
D y s p h a g ia :
Medicines like ABILIFY (aripiprazole) have been associated with
swallowing problems (dysphagia). If you had or have swallowing problems, you should
tell your healthcare professional
W h at s h o u ld I t a lk to m y h e a lt h c a r e p r o v id e r a b o u t ?
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.
B e s u r e to t e ll y o u r h e a lt h c a r e p ro v id e r:
• 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
W h at s h o u ld I a v o id w h e n t a k in g A B IL IF Y ?
• 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
W h at a r e th e p o s s ib le s id e e f f e c t s o f A B IL IF Y ?
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.
W h at p e r c e n t a g e o f p e o p le s t o p p e d t a k in g A B IL IF Y d u e to
s id e e f f e c t s ?
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%).
C a n I s a f e ly t a k e A B IL IF Y w h ile I’m ta k in g o th e r m e d ic a t io n s ?
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:
• kétoconazole (NIZORAL®)
• quinidine (QUINIDEX*1
)
• 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.
G e n e r a l a d v ic e a b o u t A B IL IF Y :
• 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
F in d o u t m o re a b o u t A B IL IF Y :
Additional information can be found at www.abillfy.com
* NI70RAI
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of
W yeth Pharm aceuticals; PRO ZAC is a registered tradem ark of Eli Lilly and Com pany; p a x ii is a registered
tradem ark of GlaxoSmithKline; TEG RETO L Is a registered tradem ark of Novartis Pharm aceuticals.
Based on Full Prescribing Information as of 05/08 I239550A2.
f e ? Bristol-Myers Squibb
OtSukci
Olsuka America Pharmaceutical,Inc.
Tablais luaiinfncliirinl by O lsuka Р Ііапм аш іІіізіІ C o , I t il, Tokyo, 101 8 5 3 5 .Іа|кіп їм
önstol-M ye rs Squibb Com pany. Pnnceton. N J U 8543 USA.
Orally Disinteqratinq Tablets. Oral Solution, and injection m anufactured by
R iis M Myi:o; Squilil) Com pany, Princeton. N.I 0 8 5 4 3 U SA
Uistnbuted and marketed by O tsuka Am enca Pharmaceutical. Inc.
. Rockville. M U 2U85U USA.
M arketed by Bristol-M yers Squibb Company. Princeton, N J 0 8 5 4 3 U SA
ll.S. РаїнпІ Nos. 5,005.528; 5 977,257; and 7.115.587.
<D2UU8 U tsuka Am erica Pharm aceutical. Inc.
. Rockville. M U
5 7 0 U S 0 0 C B 5 0 I6 0 1
030Ö L-1141
Printed in U S A
D 6 -B 0 0 0 ID -0 5 -0 0 -M D D
M a y 2 0 0 8
