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Abilify (aripiprazole)

Guide to ABILIFY.com

Guide for People with Bipolar I Disorder, their Family, and Friends
Guide for Healthcare Professionals
IMPORTANT SAFETY INFORMATION
FULL PRODUCT INFORMATION including Boxed Warning
 

For people with Bipolar I Disorder, their family, and friends:

ABILIFY.com Home Page
        • ABILIFY and Bipolar I Disorder
        • What is Bipolar Disorder?
          • Resources for Information
        • What is ABILIFY?
        • IMPORTANT SAFETY INFORMATION
        • FULL PRODUCT INFORMATION including Boxed WARNING
        • Commonly Asked Questions About Side Effects
        • The Brain, Bipolar I Disorder, and ABILIFY — Video
        • The Brain, Bipolar I Disorder, and ABILIFY — Text
        • Personal Stories
        • Getting the Most from Treatment
          • Take ABILIFY as Prescribed
          • Make Healthy Changes to Your Lifestyle
          • Stay Connected with Family and Friends
          • Help as You Move Forward
        • Information for Family and Friends
        • Talking to Your Healthcare Professional
          • Medicine Side Effect Checklist
          • Questions to Ask Your Healthcare Professional About ABILIFY
        • Tools for Therapy
          • Calendar
          • Refill Reminder
          • BMI Calculator
          • Mood Tracker

 

For healthcare professionals:

ABILIFY.com Home Page for Healthcare Professionals  
        • Efficacy in Bipolar I Disorder  
        • Efficacy in Schizophrenia  
        • Safety  
      • Impact on Sedation  
      • Impact on Weight  
      • Metabolic Parameters  
      • Cardiovascular Parameters  
      • Other Parameters  
        • Unique Pharmacology  
        • Dosing Options  
        • Managing Expectations  
        • IMPORTANT SAFETY INFORMATION  
        • FULL PRESCRIBING INFORMATION including Boxed WARNING  
        • About Bipolar Disorder  
      • Diagnostic Criteria  
      • Mood Disorder Questionnaire  
      • Epidemiology  
      • Pathophysiology  
      • Young Mania Rating Scale  
      • Clinical Global Impression-Bipolar Scale  
        • About Schizophrenia  
      • Diagnostic Criteria  
      • Epidemiology  
      • Pathophysiology  
      • Positive and Negative Syndrome Scale (PANSS™)  

Before you start treatment with ABILIFY, you should read the IMPORTANT SAFETY INFORMATION below.  



IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY® (aripiprazole)

INDICATIONS: ABILIFY (aripiprazole) is indicated for the treatment of:
  • Acute manic and mixed episodes associated with Bipolar I Disorder
  • Maintaining efficacy in patients with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least 6 weeks
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 atypical 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.


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:
  • Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal
  • Abnormal or uncontrollable movements. These may be signs of a serious condition called tardive dyskinesia, which may be permanent
  • Elderly: An increased risk of stroke and ministroke has been reported in a clinical study of elderly patients with dementia-related psychosis
  • Diabetes, risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking medicines like ABILIFY. Ask your healthcare professional about the need to monitor your blood sugar level before and during treatment
Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with ABILIFY. Medicines like ABILIFY can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you.

Since medicines like ABILIFY can impact your body’s ability to reduce body temperature, you should avoid overheating and dehydration.

Medicines like ABILIFY have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your healthcare professional.

If you have suicidal thoughts, you should tell your healthcare professional right away.

While taking ABILIFY, avoid:
  • Drinking alcohol
  • Breast-feeding an infant
Tell your healthcare professional if you have a history of seizures, or are pregnant or intend to become pregnant, and about all prescription and non-prescription medicines you are taking or plan to take.

Other common side effects include: headache, anxiety, insomnia, nausea, vomiting, constipation, dizziness, upset stomach, and an inner sense of restlessness or need to move (akathisia).

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

For patients who cannot metabolize phenylalanine (those with phenylketonuria or PKU), ABILIFY® DISCMELT™ (aripiprazole) contains phenylalanine.

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

Please see IMPORTANT SAFETY INFORMATION and FULL PRODUCT INFORMATION including Boxed WARNING for ABILIFY (aripiprazole).

Bristol-Myers Squibb Company Otsuka America Pharmaceutical, Inc.
 D6-DD0578      January 2007      AC444682/10-06  <%= sCrispDate %> <%= sCrispPostfix %>
© 2007 Otsuka America Pharmaceutical, Inc. All Rights Reserved.
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