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INDICATIONS and IMPORTANT SAFETY INFORMATION for ABILIFY MAINTENA® (aripiprazole)
Elderly people with dementia-related psychosis are at increased risk of death when treated with antipsychotic medicines including ABILIFY MAINTENA. ABILIFY MAINTENA is not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Do not receive ABILIFY MAINTENA if you are allergic to aripiprazole or any of the ingredients in ABILIFY MAINTENA. Allergic reactions to aripiprazole 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.
ABILIFY MAINTENA may cause serious side effects including:
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
If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
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.
Before receiving ABILIFY MAINTENA, tell your healthcare provider about all your medical conditions, including if you:
have never taken aripiprazole before
have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving ABILIFY MAINTENA and during your treatment.
have or had seizures (convulsions)
have or had low or high blood pressure
have or had heart problems or a stroke
have or had a low white blood cell count
have problems that may affect you receiving an injection in your arm or buttocks
are pregnant or plan to become pregnant. It is not known if ABILIFY MAINTENA will harm your unborn baby. If you become pregnant while receiving ABILIFY MAINTENA, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
are breastfeeding or plan to breastfeed. ABILIFY MAINTENA can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ABILIFY MAINTENA.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
ABILIFY MAINTENA and other medicines may affect each other causing possible serious side effects. Do not start or stop any medicines during treatment with ABILIFY MAINTENA without talking to your healthcare provider first.
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).
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.
These are not all the possible side effects of ABILIFY MAINTENA.
If you have any questions about your health or medicines, talk to your healthcare provider.
You are encouraged to report side effects of ABILIFY MAINTENA (aripiprazole). Please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
ABILIFY MAINTENA® (aripiprazole) is a prescription medicine given by injection by a healthcare professional for:
It is not known if ABILIFY MAINTENA is safe and effective in children under 18 years of age.
Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.
Elderly people with dementia-related psychosis are at increased risk of death when treated with antipsychotic medicines including ABILIFY MAINTENA. ABILIFY MAINTENA is not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
Do not receive ABILIFY MAINTENA if you are allergic to aripiprazole or any of the ingredients in ABILIFY MAINTENA. Allergic reactions to aripiprazole 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.
ABILIFY MAINTENA may cause serious side effects including:
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
If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
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.
Before receiving ABILIFY MAINTENA, tell your healthcare provider about all your medical conditions, including if you:
have never taken aripiprazole before
have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving ABILIFY MAINTENA and during your treatment.
have or had seizures (convulsions)
have or had low or high blood pressure
have or had heart problems or a stroke
have or had a low white blood cell count
have problems that may affect you receiving an injection in your arm or buttocks
are pregnant or plan to become pregnant. It is not known if ABILIFY MAINTENA will harm your unborn baby. If you become pregnant while receiving ABILIFY MAINTENA, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
are breastfeeding or plan to breastfeed. ABILIFY MAINTENA can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ABILIFY MAINTENA.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
ABILIFY MAINTENA and other medicines may affect each other causing possible serious side effects. Do not start or stop any medicines during treatment with ABILIFY MAINTENA without talking to your healthcare provider first.
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).
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.
These are not all the possible side effects of ABILIFY MAINTENA.
If you have any questions about your health or medicines, talk to your healthcare provider.
You are encouraged to report side effects of ABILIFY MAINTENA (aripiprazole). Please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
ABILIFY MAINTENA® (aripiprazole) is a prescription medicine given by injection by a healthcare professional for:
It is not known if ABILIFY MAINTENA is safe and effective in children under 18 years of age.
Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.