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Please see U.S. FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.

Initial Rollout for the ABILIFY MYCITE® System

Our approach for this first-of-its-kind treatment is novel for a pharmaceutical company. We are launching the ABILIFY MYCITE System in close collaboration with only a select number of health plans and providers.

This limited rollout is purposeful. Having fewer people using the ABILIFY MYCITE System initially means we can listen to each of them more closely, and answer the questions:

  • How does the ABILIFY MYCITE System fit best within the daily lives of those with serious mental illness and their loved ones?
  • How do doctors integrate this system into their daily practice?
  • How can we improve this digital ingestion tracking system to better serve patients, healthcare providers, and health plans?

In this way—through ongoing feedback from those using this digital ingestion tracking system in their daily lives—we will further enhance the experience for all prospective patients, their families and care teams of the ABILIFY MYCITE System.

This initial product rollout will be a crucial step in our broader go-to-market plan.

If you have any questions about the system or ABILIFY MYCITE® (aripiprazole tablets with sensor), your health, or the medicines you take, talk to your doctor. Ask if ABILIFY MYCITE may be an appropriate treatment option for you. During the Initial Rollout, ABILIFY MYCITE will only be covered under a limited number of health plans and will only be available to a limited number of those health plans' member population.

Frequently Asked Initial Rollout Questions

What is 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.

Who should not take ABILIFY MYCITE?

Do not take ABILIFY MYCITE if you are allergic to aripiprazole or any of the ingredients in ABILIFY MYCITE. See the MEDICATION GUIDE for a complete list of ingredients in ABILIFY MYCITE.

Is the ABILIFY MYCITE System available to all prospective patients and their doctors?

ABILIFY MYCITE is a first-of-its-kind treatment, so there will be limited product availability at launch. We are rolling out the ABILIFY MYCITE System in close collaboration with only a limited number of health plans and their affiliated doctors through this launch period. The doctors will be able to prescribe to those patients who are appropriate for the ABILIFY MYCITE System.

How can prospective ABILIFY MYCITE patients find out if they are eligible or have access?

If you have any questions about ABILIFY MYCITE, your health, or the medicines you take, talk to your doctor. Speak to your doctor first to see if ABILIFY MYCITE may be an appropriate treatment option for you. You should also contact your healthcare insurance group to see if their network covers ABILIFY MYCITE now or in the future.

During the Initial Rollout, ABILIFY MYCITE will only be covered under a limited number of health plans and will only be available to a limited number of those health plans' member population.

How long will the Initial Rollout last before the ABILIFY MYCITE System is more broadly available?

A limited initial launch will allow us to gather feedback and further enhance the experience for all prospective users of the ABILIFY MYCITE System. The progress of this initial limited rollout will help us determine timing for a broader product launch.

Please check back here for updates and important news pertaining to the ABILIFY MYCITE System.

INDICATIONS and IMPORTANT SAFETY INFORMATION for ABILIFY MYCITE® (aripiprazole tablets with sensor)

INDICATIONS:

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:

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

    • high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take ABILIFY MYCITE. 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 starting ABILIFY MYCITE and during your treatment.

      Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving ABILIFY MYCITE:

      • feel very thirsty
      • feel weak or tired
      • need to urinate more than usual
      • feel sick to your stomach
      • feel very hungry
      • 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 taking aripiprazole 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.
  • Falls
  • Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with ABILIFY MYCITE.
  • Seizures (convulsions)
  • Problems with control of your body temperature so that you feel too warm. Do not become too hot or dehydrated during treatment with ABILIFY MYCITE. Avoid getting over-heated or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun, and do not wear too much or heavy clothing. Drink plenty of water.
  • Difficulty swallowing

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:

  • diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before starting and during therapy with ABILIFY MYCITE
  • seizures (convulsions)
  • low or high blood pressure
  • heart problems or stroke
  • low white blood cell count
  • pregnancy or plans to become pregnant. It is not known if ABILIFY MYCITE will harm your unborn baby.

  • breast-feeding or plans to breast-feed. ABILIFY MYCITE can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ABILIFY MYCITE
  • all other medical conditions

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 www.fda.gov/medwatch.

IMPORTANT SAFETY INFORMATION and INDICATIONS for
ABILIFY MYCITE® (aripiprazole tablets with sensor)

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:

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

    • high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take ABILIFY MYCITE. 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 starting ABILIFY MYCITE and during your treatment.

      Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving ABILIFY MYCITE:

      • feel very thirsty
      • feel weak or tired
      • need to urinate more than usual
      • feel sick to your stomach
      • feel very hungry
      • 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 taking aripiprazole 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.
  • Falls
  • Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with ABILIFY MYCITE.
  • Seizures (convulsions)
  • Problems with control of your body temperature so that you feel too warm. Do not become too hot or dehydrated during treatment with ABILIFY MYCITE. Avoid getting over-heated or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun, and do not wear too much or heavy clothing. Drink plenty of water.
  • Difficulty swallowing

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:

  • diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before starting and during therapy with ABILIFY MYCITE
  • seizures (convulsions)
  • low or high blood pressure
  • heart problems or stroke
  • low white blood cell count
  • pregnancy or plans to become pregnant. It is not known if ABILIFY MYCITE will harm your unborn baby.

  • breast-feeding or plans to breast-feed. ABILIFY MYCITE can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ABILIFY MYCITE
  • all other medical conditions

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 www.fda.gov/medwatch.

INDICATIONS:

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.