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ABILIFY MAINTENA- aripiprazole kit


  1. Patient Information
  2. Advise Patients And Their Caregivers Of The Possibility That They May Experience Compulsive Urges To Shop, Increased Urges To Gamble, Compulsive Sexual Urges, Binge Eating And/or Other Compulsive Urges And The Inability To Control These Urges While Taking Aripiprazole. In Some Cases, But Not All, The Urges Were Reported To Have Stopped When The Dose Was Reduced Or Stopped[each Injection Of Abilify Maintena Must Be Administered By A Healthcare Professional Only.abilify Maintena May Cause Serious Side Effects, Including:
  3. What Is Abilify Maintena?
  4. What Should I Avoid While Receiving Abilify Maintena?
  5. See "what Is The Most Important Information I Should Know About Abilify Maintena?
  6. High Blood Sugar (hyperglycemia):
  7. Call Your Healthcare Provider If You Have Any Of These Symptoms Of High Blood Sugar While Receiving Abilify Maintena:
  8. Problems Controlling Your Body Temperature So That You Feel Too Warm. See "what Should I Avoid While Receiving Abilify Maintena?
  9. The Most Common Side Effects Of Abilify Maintena Include:
  10. What Are The Ingredients In Abilify Maintena?active Ingredient:
  11. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide)

Pathological Gambling and Other Compulsive Behaviors

Advise Patients And Their Caregivers Of The Possibility That They May Experience Compulsive Urges To Shop, Increased Urges To Gamble, Compulsive Sexual Urges, Binge Eating And/or Other Compulsive Urges And The Inability To Control These Urges While Taking Aripiprazole. In Some Cases, But Not All, The Urges Were Reported To Have Stopped When The Dose Was Reduced Or Stopped[each Injection Of Abilify Maintena Must Be Administered By A Healthcare Professional Only.abilify Maintena May Cause Serious Side Effects, Including: 

  • Increased risk of death in elderly people with dementia-related psychosis.ABILIFY MAINTENA is not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).

What Is Abilify Maintena? 


ABILIFY MAINTENA is a prescription medicine given by injection by a healthcare professional for:
  • treatment of schizophrenia in adults
  • maintenance treatment of bipolar I disorder in adults
It is not known if ABILIFY MAINTENA is safe and effective in children under 18 years of age.Do not receive ABILIFY MAINTENA if youare allergic to aripiprazole or any of the ingredients in ABILIFY MAINTENA.
  • Follow your ABILIFY MAINTENA treatment schedule exactly as your healthcare provider tells you to.
  • ABILIFY MAINTENA is an injection given in your arm or buttock by your healthcare provider 1 time every month. You may feel a little pain in your arm or buttock during your injection.
  • After your first injection of ABILIFY MAINTENA you should continue your current antipsychotic medicine for 2 weeks.
  • You should not miss a dose of ABILIFY MAINTENA. If you miss a dose for some reason, call your healthcare provider right away to discuss what you should do next.

What Should I Avoid While Receiving Abilify Maintena? 

  • Do not drive, operate machinery, or do other dangerous activities until you know how ABILIFY MAINTENA affects you. ABILIFY MAINTENA may make you feel drowsy.
  • Do not drink alcohol while you receive ABILIFY MAINTENA.
  • Do not become too hot or dehydrated while you receive ABILIFY MAINTENA.
    • Do not exercise too much.
    • In hot weather, stay inside in a cool place if possible.
    • Stay out of the sun.
    • Do not wear too much clothing or heavy clothing.
    • Drink plenty of water.

See "what Is The Most Important Information I Should Know About Abilify Maintena? 

"
  • Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.
  • Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death.Call your healthcare provider or go to the nearest emergency room right away if you have some or all of the following symptoms of NMS:
    • high fever
    • confusion
    • changes in pulse, heart rate, and blood pressure
    • stiff muscles
    • sweating
    • Uncontrolled body movements (tardive dyskinesia).ABILIFY MAINTENA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ABILIFY MAINTENA. Tardive dyskinesia may also start after you stop receiving ABILIFY MAINTENA.

    High Blood Sugar (hyperglycemia): 

    Increases in blood sugar can happen in some people who receive ABILIFY MAINTENA. 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 receiving ABILIFY MAINTENA and during your treatment.

    Call Your Healthcare Provider If You Have Any Of These Symptoms Of High Blood Sugar While Receiving Abilify Maintena: 

    • 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
  • Increased fat levels (cholesterol and triglycerides) in your blood.
  • Weight gain.You and your healthcare provider should check your weight regularly.
  • Unusual urges.Some people receiving ABILIFY MAINTENA have had unusual urges such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
  • Decreased blood pressure (orthostatic hypotension).You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
  • Low white blood cell count
  • Seizures (convulsions)
  • Problems Controlling Your Body Temperature So That You Feel Too Warm. See "what Should I Avoid While Receiving Abilify Maintena? 

    "
  • Difficulty swallowing
  • The Most Common Side Effects Of Abilify Maintena Include: 

    weight gain, inner sense of restlessness such as feeling like you need to move (akathisia), injection site pain, or sleepiness (sedation).
    These are not all the possible side effects of ABILIFY MAINTENA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.General information about the safe and effective use of ABILIFY MAINTENA.
    If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ABILIFY MAINTENA that is written for healthcare professionals.

    What Are The Ingredients In Abilify Maintena?active Ingredient: 

    aripiprazole monohydrate

    Inactive Ingredients: 

    carboxymethyl cellulose sodium, mannitol, sodium phosphate monobasic monohydrate and sodium hydroxide
    ABILIFY MAINTENA is a trademark of Otsuka Pharmaceutical Co., Ltd.
    2017, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan
    For more information, go to www.ABILIFYMAINTENA.com or call 1-800-441-6763.



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