IMPORTANT INFORMATION ABOUT ABILIFY
(aripiprazole)
2.5,10.1S, 20,30 mg Tjblvti
ABILIFY
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-r-fi)
(aripiprazole) (air-ri-PIP-ra-zall)
What is A B ILIFY ?
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 M edicines, Depression and Other Serious Mental Illnesses, and Suicidal
Thoughts or Actions.
Who should NOT take A B ILIFY ?
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 A B ILIFY ?
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 m inistroke in elderly patients with 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 approved for treating patients with dementia.
Neuroleptic
m alignant
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.
Suicidal
thoughts:
If you have suicidal thoughts, you should tell your
healthcare professional right away.
Dysphagia:
Medicines like ABILIFY (aripiprazole) 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 nonprescription
(over-the-counter) medicines.
Be sure to tell your healthcare provider:
• 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
What should I avoid when taking A B ILIFY ?
• 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 A B ILIFY ?
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.
What percentage of people stopped taking A B ILIFY due to
side effects?
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%).
Can I safely take ABILIFY while I’m taking other m edications?
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 medicines4 include:
• ketoconazole (NIZORAL^)
• quimdine (QUINIDEX®)
• fluoxetine (PROZAC^
• paroxetine (PAXIL00)
• carbamazepine (TEGRETOL®)
It is important to tell your healthcare professional about all the medicines you’re taking, just to be sure.
General advice about ABILIFY:
• ARIIIFY is usually laken 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
Find out more about ABILIFY:
Additional information can be found at www.ablllfy.com
' NIZORAL is a registered trademark of Janssen Pharmaceutical OUINIDEX 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 ot 05/08 1239550A2.
Bristol-Myers Squibb
O ts u k a
Otsuka America PharmaceuticaUni.
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
Oistnbuted 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.
©2008 Otsuka America Pharmaceutical. Inc.
. Rockville. MD
570US08CBS01601
0308L-1141
PnntedmUSA
D6-B0001D-05-08-MDD
May 2008
