INDICATIONS and IMPORTANT SAFETY INFORMATION for ABILIFY MYCITE® (aripiprazole tablets with sensor)
ABILIFY MYCITE is a prescription medicine of an aripiprazole tablet with an Ingestible Event Marker (IEM) sensor inside it used in adults for the:
- Treatment of schizophrenia
- Treatment of bipolar I disorder alone or when used with the medicine lithium or valproate for:
- acute (short-term) treatment of manic or mixed episodes
- maintenance treatment
- Treatment of major depressive disorder (MDD) along with other antidepressant medicines
The ABILIFY MYCITE System is intended to track if you have taken your ABILIFY MYCITE. There may be a delay in the detection of the ABILIFY MYCITE tablet and sometimes the detection of the tablet might not happen at all. If the MYCITE APP does not indicate that you have taken your medicine, do not repeat the dose. It is not known if ABILIFY MYCITE can improve how well you take your aripiprazole (patient compliance) or for changing your dose of aripiprazole. ABILIFY MYCITE is not for use as real-time or emergency monitoring.
IMPORTANT SAFETY INFORMATION:
- Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ABILIFY MYCITE can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY MYCITE is not approved to treat patients with dementia-related psychosis.
- Increased risk of suicidal thoughts or actions in children and young adults: Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. Pay close attention to any changes, especially new and sudden changes, in mood, behaviors, thoughts, or feelings and report them to the healthcare provider. It is not known if ABILIFY MYCITE is safe and effective for use in children.
Do not take ABILIFY MYCITE if you are allergic to aripiprazole or any of the ingredients in ABILIFY MYCITE. Allergic reactions may include: rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue.
ABILIFY MYCITE may cause serious side effects, including:
ABILIFY MYCITE may make you drowsy. Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY MYCITE affects you.
Before taking ABILIFY MYCITE, tell your healthcare provider if you have or had:
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ABILIFY MYCITE and other medicines may affect each other causing possible serious side effects. ABILIFY MYCITE may affect the way other medicines work, and other medicines may affect how ABILIFY MYCITE works. Do not start or stop any medicines while taking ABILIFY MYCITE without talking to your healthcare provider first.
The most common side effects of ABILIFY MYCITE in adults include: restlessness or need to move (akathisia); dizziness; nausea; insomnia; shaking (tremor); anxiety; constipation; sedation
These are not all the possible side effects of ABILIFY MYCITE. Call your doctor for medical advice about side effects. You are encouraged to report side effects to Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or .