Your guide to starting the ABILIFY MYCITE® System

Once you and your healthcare provider decide ABILIFY MYCITE® (aripiprazole tablets with sensor) is right for you, it’s time to set up the system.
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Download the MYCITE® App

The MYCITE App is one part of the ABILIFY MYCITE System

Everything on this app is designed to give you a more complete picture of how you are doing during your treatment. Not only will the app walk you through each step of the setup process and show your daily data, it’ll also send you helpful alerts and notifications, like when it’s time to change your MYCITE® Patch.

Interested in what the MYCITE App has to offer? Talk to your doctor about getting a prescription. If you already have a prescription, download the MYCITE App from the App Store® or Google Play store and get started today.

 

 

 

It is not known if ABILIFY MYCITE can improve how well you take your aripiprazole (patient compliance) or for changing your dose of aripiprazole. Some factors, such as a bad connection or reception, or not having your smartphone, may impact the consistency and reliability of data being detected, collected, and transmitted.

Only functions related to tracking drug ingestion have been evaluated or approved by FDA.

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See what’s in the ABILIFY MYCITE® Kit

When you start, your healthcare provider will help set you up with the system and will provide an overview of everything that is in the kit. The packaging has instructions on how to download the MYCITE App. 

An ABILIFY MYCITE Kit includes:

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30 days’ worth of ABILIFY MYCITE
Smartphone with MYCITE® Patch, Icon
7 MYCITE Patches, which connect to your smartphone app through Bluetooth®*
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Instructions on how to set up the system on the app 
*
Bluetooth is a registered trademark of Bluetooth SIG, Inc.

Setting up the system

The Instructions for Use videos offer a step-by-step look at how to set up the ABILIFY MYCITE System. These videos are available in the MYCITE App, and you can watch them when you start to set up the system and take your medicine.

If, at any time, you need help with a specific step, you can return here or rewatch the videos within the “Help” section of the app.
 

Applying the MYCITE Patch

When prescribed, follow your doctor’s instructions for using the ABILIFY MYCITE System and for taking ABILIFY MYCITE.

DO NOT place the patch in areas where your skin is scraped, cracked, inflamed, or irritated. 

DO NOT place the patch in a location that overlaps with the area of the most recently removed patch.

1 in 8 patients in clinical studies experienced skin irritation at the site of patch placement.
 

Person wearing MYCITE® Patch

Get more information about savings and the prescription process for the ABILIFY MYCITE Kit.

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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
      • 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
      • 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 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
  • have or had seizures (convulsions)
  • have or had low or high blood pressure
  • have or had heart problems or stroke
  • have or had low white blood cell count
  • are pregnant or have plans to become pregnant. It is not known if ABILIFY MYCITE will harm your unborn baby.
  • are breast-feeding or have 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
  • have or had any 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.

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.