Long-lasting symptom control* may be possible with 1 treatment every 2 months.†
Learn about a once-monthly option
Learn about a once-monthly option
INDICATIONS:
ABILIFY ASIMTUFII is a prescription medicine given by injection by a healthcare professional:
ABILIFY MAINTENA is a prescription medicine given by injection by a healthcare professional:
It is not known if ABILIFY ASIMTUFII or ABILIFY MAINTENA is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION:
Increased risk of death in elderly people with dementia-related psychosis. ABILIFY ASIMTUFII and ABILIFY MAINTENA increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY ASIMTUFII and ABILIFY MAINTENA are not for the treatment of people with dementia-related psychosis.
Do not receive ABILIFY ASIMTUFII or ABILIFY MAINTENA if you are allergic to aripiprazole or any of the ingredients in ABILIFY ASIMTUFII or ABILIFY MAINTENA.
ABILIFY ASIMTUFII or ABILIFY MAINTENA may cause serious side effects, including:
High blood sugar (hyperglycemia) and diabetes: Increases in blood sugar can happen in some people who are treated with ABILIFY ASIMTUFII or 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 treatment with ABILIFY ASIMTUFII or ABILIFY MAINTENA, and during treatment.
Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with ABILIFY ASIMTUFII or 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
Do not drink alcohol during treatment with ABILIFY ASIMTUFII or ABILIFY MAINTENA.
Before receiving ABILIFY ASIMTUFII or ABILIFY MAINTENA, tell your healthcare provider about all your medical conditions, including if you:
have never taken aripiprazole before
have or had 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 ASIMTUFII or ABILIFY MAINTENA and during your treatment.
have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
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 or had seizures (convulsions)
have problems that may affect you receiving an injection in your buttocks (ABILIFY ASIMTUFII and ABILIFY MAINTENA) or arm (ABILIFY MAINTENA)
are pregnant or plan to become pregnant. ABILIFY ASIMTUFII or ABILIFY MAINTENA may harm your unborn baby. If you become pregnant during treatment with ABILIFY ASIMTUFII or ABILIFY MAINTENA, talk to your healthcare provider about the risk to your unborn baby and about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://
are breastfeeding or plan to breastfeed. ABILIFY ASIMTUFII or 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 ASIMTUFII or ABILIFY MAINTENA.
Tell your healthcare provider about all the medicines you take, including prescription medicine and over-the-counter medicines, vitamins, and herbal supplements.
ABILIFY ASIMTUFII or 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 ASIMTUFII or ABILIFY MAINTENA without talking to your healthcare provider first.
The most common side effects of ABILIFY ASIMTUFII or ABILIFY MAINTENA include: weight gain, restlessness or 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 ASIMTUFII or 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 ASIMTUFII and ABILIFY MAINTENA.
Please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE for ABILIFY ASIMTUFII and ABILIFY MAINTENA.