ABILIFY® (aripiprazole) | Doctor Discussion Guide

U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide

IMPORTANT SAFETY INFORMATION

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 these patients.

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The Doctor Discussion Guide gives you the opportunity to create a list of questions based on your specific needs and concerns. Simply select a question by checking the box next to it. Your question will then appear on the right side of the page in the "your discussion guide" box. When you have selected all of your questions, click on the “FINISH AND PRINT” button so you can view and then print your full list of questions.

YOUR DISCUSSION GUIDE:

Doctor, I have some questions and concerns about my Bipolar I Disorder treatment

How should I take ABILIFY?
Could my dosage change over time?
Does everyone with Bipolar Disorder take the same starting dose of ABILIFY?
What time of day is best to take my medication?
What should I do if I accidentally miss a dose?
How will ABILIFY interact with my other medications?
Can ABILIFY be used by people under 18?
Can I stop taking ABILIFY if I feel better?

If I am transitioning from another medication, what steps should I be taking?
How is ABILIFY thought to work?

How will ABILIFY help to treat my symptoms?
How long should I give my body to adjust to ABILIFY?
What should I do if I am concerned that my symptoms are not under control?
How will I know if my symptoms are coming back?

Do all medications for Bipolar Disorder cause side effects?
What are the possible side effects of taking ABILIFY?
Will ABILIFY affect my weight?
Will ABILIFY affect my blood sugar?
Will ABILIFY make me tired or sleepy?
Will ABILIFY affect my sexual function?
What should I do if I experience side effects?
What are the things I can do to help cope with the side effects I am experiencing?

How can medication help control my symptoms of Bipolar Disorder?
Will I need to be on medication for a long time?
What could happen if I stop taking my medication, even if I am feeling better?
Is Bipolar Disorder hereditary?
Is there information I could provide to my family and friends about Bipolar Disorder?

What are some ways to remember to take my medication as directed?
What other things, such as talk therapy or lifestyle changes, can help keep my symptoms under control?

Additional concerns or questions

Please type any additional concerns or questions you may have about your Bipolar Disorder treatment:

Comments:

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY^® (aripiprazole)

IMPORTANT SAFETY INFORMATION:

Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with antipsychotic medicines including ABILIFY, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis (see Boxed WARNING).

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 provider right away, especially if they are severe or occur suddenly. ABILIFY is not approved for use in pediatric patients with depression (see Boxed WARNING).

Contraindication: Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in ABILIFY. Allergic reactions have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.

Serious side effects may include:

An increased risk of stroke and ministroke have been reported in clinical studies of elderly people with dementia-related psychosis
High fever, stiff muscles, confusion, sweating, changes in pulse, heart rate and blood pressure may be signs of a condition called
neuroleptic malignant syndrome (NMS), a rare and serious condition that can lead to death
Increases in blood sugar levels (hyperglycemia) 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 example, obesity, family history of diabetes), or have the following symptoms: increases in thirst, urination, or hunger, feel weak or tired, sick to your stomach, or confused (or breath smells fruity), your blood sugar should be monitored
Changes in cholesterol and triglyceride (fat, also called lipids) levels in the blood have been seen in patients taking medicines like ABILIFY
Weight gain has been reported in patients taking medicines like ABILIFY so your weight should be checked regularly. Weight gain in children (ages 6 to 17) should be compared against that expected with normal growth
ABILIFY and medicines like it have been associated with difficulty swallowing which may lead to aspiration or choking
Uncontrollable movements of face, tongue, or other parts of body, as these may be signs of a serious condition called tardive dyskinesia (TD). TD may not go away, even if you stop taking ABILIFY. TD may also start after you stop taking ABILIFY
Orthostatic hypotension (decreased blood pressure) or lightheadedness or fainting when rising too quickly from a sitting or lying position has been reported with ABILIFY
Decreases in white blood cells (WBC; infection fighting cells) have been reported in some patients taking ABILIFY. Patients with a history of a significant decrease in WBC count or who have experienced a low WBC count due to drug therapy should have their blood tested and monitored during the first few months of therapy
Seizures (convulsions) have been reported with ABILIFY. Tell your healthcare provider if you have a history of or are at risk for seizures
ABILIFY and medicines like it can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you
Medicines like ABILIFY can impact your body's ability to reduce body temperature; you should avoid overheating and dehydration
Tell your healthcare provider if you are pregnant or intend to become pregnant. Also tell your healthcare provider about any other medical conditions you have and about all prescription and non-prescription medicines you are taking or plan to take since there are some risks for drug interactions

While taking ABILIFY, avoid:

Drinking alcohol
Breast-feeding an infant

Most common side effects (≥10%) from all clinical trials involving adults or pediatric patients include:

ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety, insomnia, and restlessness
PEDIATRIC PATIENTS (6 to 17 years): Sleepiness, headache, vomiting, extrapyramidal disorder (for example, uncontrolled movement disorders or muscle disturbances such as restlessness, tremors and muscle stiffness), fatigue, increased appetite, insomnia, nausea, stuffy nose, and weight gain

It is important to contact your healthcare provider if you experience prolonged, abnormal muscle spasms or contractions, which may be signs of a condition called dystonia.

For patients who must limit their sugar intake, ABILIFY Oral Solution contains sugar.

For patients with phenylketonuria or PKU, ABILIFY DISCMELT^® (aripiprazole) contains phenylalanine.

If you have any questions about your health or medicines, talk to your healthcare provider.

INDICATIONS: ABILIFY is indicated for:

Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy
Treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17 years of age
Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age
Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age

Special Considerations for Pediatric Uses:

Discuss the risks and benefits of treatment with your child's healthcare provider. Treatment should be started only after a thorough diagnostic evaluation and as part of a total treatment program

Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide for ABILIFY.

570US11WA21303 September 2011 03US12W-0125

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Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide.

Doctor Discussion Guide

I HAVE QUESTIONS ABOUT:

Taking ABILIFY ^® (aripiprazole)

Changing medications

Monitoring my progress

Side effects of medication

Questions about Bipolar Disorder

Tips for healthy living

YOUR DISCUSSION GUIDE:

Doctor, I have some questions and concerns about my Bipolar I Disorder treatment

Additional concerns or questions

Comments:

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY^® (aripiprazole)

	How should I take ABILIFY?
	Could my dosage change over time?
	Does everyone with Bipolar Disorder take the same starting dose of ABILIFY?
	What time of day is best to take my medication?
	What should I do if I accidentally miss a dose?
	How will ABILIFY interact with my other medications?
	Can ABILIFY be used by people under 18?
	Can I stop taking ABILIFY if I feel better?

	If I am transitioning from another medication, what steps should I be taking?
	How is ABILIFY thought to work?

	How will ABILIFY help to treat my symptoms?
	How long should I give my body to adjust to ABILIFY?
	What should I do if I am concerned that my symptoms are not under control?
	How will I know if my symptoms are coming back?

	Do all medications for Bipolar Disorder cause side effects?
	What are the possible side effects of taking ABILIFY?
	Will ABILIFY affect my weight?
	Will ABILIFY affect my blood sugar?
	Will ABILIFY make me tired or sleepy?
	Will ABILIFY affect my sexual function?
	What should I do if I experience side effects?
	What are the things I can do to help cope with the side effects I am experiencing?

Doctor Discussion Guide

I HAVE QUESTIONS ABOUT:

Taking ABILIFY ® (aripiprazole)

Changing medications

Monitoring my progress

Side effects of medication

Questions about Bipolar Disorder

Tips for healthy living

YOUR DISCUSSION GUIDE:

Doctor, I have some questions and concerns about my Bipolar I Disorder treatment

Additional concerns or questions

Comments:

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY® (aripiprazole)

Taking ABILIFY ^® (aripiprazole)

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY^® (aripiprazole)