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Starting the ABILIFY MYCITE® System

If you have been diagnosed with major depressive disorder, bipolar I disorder, or schizophrenia and your doctor has determined the ABILIFY MYCITE System is right for you, they will provide you with a prescription for an ABILIFY MYCITE® Kit. The kit is covered under many insurance plans. Find more information here.

An ABILIFY MYCITE Kit can be prescribed by a healthcare provider, such as a psychiatrist, psychiatric nurse practitioner, or primary care physician.

An ABILIFY MYCITE® Starter Kit includes:

  • 30 days’ worth of ABILIFY MYCITE® (aripiprazole tablets with sensor)
  • MYCITE Patches (1 reusable pod and 7 disposable adhesive strips), which connect to your smartphone app through Bluetooth®*
  • Instructions on how to set up the system on the app

Monthly prescription refills will be shipped out in the ABILIFY MYCITE® Maintenance Kits. These maintenance kits will include everything from the starter kit except the reusable pod, since it can be used for up to 1 year.

Although your healthcare team and support network cannot connect to the app, they can access the daily data you choose to share through the MYCITE® Dashboard. Learn more here.

*
Bluetooth is a registered trademark of Bluetooth SIG, Inc.

Interested in talking about the ABILIFY MYCITE System with your healthcare team? In addition to the self-check tool, these questions can help you start the conversation:

  • What are some ways you and I can work together to stay on top of my treatment?
  • Would you support me in doing more to stay on top of my mental health treatment by using the ABILIFY MYCITE System?
  • What can we do to help all the people who support me stay connected with where I am in my treatment?

Letting your healthcare provider know about what you want and what is important in your life can help them understand why you think the ABILIFY MYCITE System may be right for you. Consider bringing up what you want to get out of your treatment, like:

  • I want help knowing if I’ve taken my medication and keeping track of when I’m taking it
  • I want to see information about my treatment to help me communicate with my healthcare team
  • I’m about to make some changes in my life, such as [bring up whatever is on your mind]. How can I make sure I stay on top of taking my medication as I go through this transition?
  • I want a way to involve my support network in my treatment

The MYCITE Team is here for any technical questions about the ABILIFY MYCITE System. You can call the team if you need help troubleshooting the app.

Once your doctor has prescribed you an ABILIFY MYCITE Kit, you can connect with a PEL. A PEL is a dedicated nurse you can directly reach out to throughout your treatment journey. They can help you get started with the ABILIFY MYCITE System and can answer questions you may have about your medication, the prescription process, and the MYCITE® App.

Learn more about the MYCITE Team and PEL program here.

Want to inspire others by sharing about your experience using the system? If you are currently being treated or were previously treated using the ABILIFY MYCITE System, you can call 1-844-815-0984 or email [email protected] to learn more.

About MYCITE

Learn more about the ABILIFY MYCITE System

If you already take aripiprazole, the medication is the same. However, with ABILIFY MYCITE, each aripiprazole pill has built-in technology the size of a grain of sand. If you currently take aripiprazole, you might be surprised by how similar ABILIFY MYCITE is in size and weight. The sensor is made entirely of ingredients found in most diets. After you take the pill, the sensor will pass through your body naturally and leave as waste.

ABILIFY MYCITE may cause serious side effects, including:
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.

See additional IMPORTANT SAFETY INFORMATION for ABILIFY MYCITE here.

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.

See additional IMPORTANT SAFETY INFORMATION, including BOXED WARNING, for ABILIFY MYCITE here.

There may be a few other factors that prevent you from taking ABILIFY MYCITE. Use the self-check tool and talk to your doctor to find out if it might be right for you.

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.

See additional IMPORTANT SAFETY INFORMATION for ABILIFY MYCITE here.

The ABILIFY MYCITE sensor was extensively tested in clinical studies, with 492 volunteers ranging in age from 21 to 85 years. No side effects related to the sensor were reported in these clinical trials.

In the same studies, approximately 1 in 8 patients experienced skin rashes as a result of wearing the patch.

How the MYCITE Patch works

Learn more about the ABILIFY MYCITE System

No. There is medication only in your ABILIFY MYCITE. The patch is just meant to send and receive information about your pill-taking, steps, and rest.

The adhesive strip of the MYCITE Patch is about the size of a large adhesive bandage (about 2” x 4.25”), while the pod, attached in the center, is about the size of a small watch face.

The MYCITE Patch can be applied to your stomach (under the chest and above the belly button).

Do not place the patch in areas where the skin is scraped, cracked, inflamed, or irritated, or in a location that is near a recently removed patch. Do not dispose of the pod when changing your adhesive strip.

Each reusable pod only needs to be paired once and can be used for up to 1 year.

The MYCITE® App will let you know when it’s time to change your adhesive strip. Strips should be changed at least weekly. Your doctor will let you know if you need to change them more frequently.

The patch can stay on, even through water and sweat, and does not need to be taken off in the shower or during exercise. Do not dispose of the pod when changing your adhesive strip.

If your pod comes out of the adhesive strip, you can reattach it to the adhesive strip to continue taking advantage of the ABILIFY MYCITE System.

Your 30-day ABILIFY MYCITE® Starter Kit comes with your medication and MYCITE Patches (1 reusable pod which can be used for up to 1 year and 7 disposable adhesive strips).

Monthly prescription refills will be shipped out in maintenance kits that include your medication and 7 disposable adhesive strips.

If you have any issues with your MYCITE Patch you can call the MYCITE Team at 1-844-MYCITE-4 for help.

Each patch adhesive strip contains a small battery that powers the pod. In order to make sure your MYCITE Patch never loses power, the adhesive strip should be changed at least weekly.

Privacy of the system

How you share your data starts with you. Your healthcare provider will be able to see your data automatically when you finish setup. If you want, you can share the daily data you see in the app with other members of your healthcare team, like your nurse or therapist, and anyone else you would want to view it—like close family members or friends. You can change what information you are sharing at any time.

The people with whom you choose to share your information will be able to view the data you share on the MYCITE® Dashboard, allowing them to quickly check in and see how you’re doing.

If you would like to know more about how your information will be used please review the ABILIFY MYCITE System Terms of Use, Privacy Notice, and Authorization & Consent.

No. There is no location sharing as part of the ABILIFY MYCITE System.

Yes. You may select up to 5 people in your support network to view your data. There is no limit to the number of healthcare team members with whom you choose to share.

Technical questions

If you have any questions about setting up the system, the MYCITE Team is here to help you at 844-MYCITE-4 (844-692-4834).

After you take your ABILIFY MYCITE (a prescription smart pill with built-in technology) as prescribed, it sends out a tiny signal. The MYCITE Patch receives that signal from your smart pill and logs when you take your medicine. The patch also automatically logs the number of steps you’ve taken that day and the time you've spent resting. It sends that information via Bluetooth®* to the MYCITE® App on your smartphone. On the app, you can record your mood using emojis, how well you rested, and the reason, if you didn’t take your pill. You can share this daily data with members of your healthcare team or people in your support network.

The people you decide to share your information with will be able to see your data on the MYCITE® Dashboard. The dashboard is an online portal that allows them to see how you’re doing. Your data are encrypted and stored securely in the cloud to protect your privacy. You can change what information you are sharing at any time. Learn more about the system here.

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

*
Bluetooth is a registered trademark of Bluetooth SIG, Inc.

About 94% of pills taken are registered by the patch within 3 minutes after being swallowed. You should see the information on your smartphone within 5 minutes. However, it may take up to 2 hours for the patch and app to sync up. Once the information shows up in the app, it’ll be in the MYCITE® Dashboard as well.

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.

 

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.

The MYCITE Patch records that you’ve taken your pill and will connect with the MYCITE App once it is in Bluetooth®* range, which is approximately 9 feet. You must have access to a reliable internet connection.

*
Bluetooth is a registered trademark of Bluetooth SIG, Inc.

The ABILIFY MYCITE System is compatible with most of the following devices and operating systems:

  • Apple iPhone®: iPhone 6S (or higher) with iOS® 10.x (or higher)
  • Android™: Samsung Galaxy™ S7/S8, Google Pixel™ 2 (or higher) with Android Nougat-7 (or higher)

Note: To see if the MYCITE App works with your specific smartphone, check your app store. If your phone is compatible, download the MYCITE App and follow the instructions provided.

iPhone and iOS are registered trademarks of Apple, Inc.
"Samsung" and "Galaxy" are trademarks of Samsung in the United States or other countries.
"Google,” "Android,” and ”Pixel" are trademarks of Google, LLC.

Your patch is designed to pair with your smartphone. If you need to change your smartphone for any reason, please contact the MYCITE Team at 844-MYCITE-4 (844-692-4834), so you can get a new pod to pair with your device. 

The ABILIFY MYCITE System will still work outside of the country. Data plan and roaming charges may apply based on your phone plan and Wi-Fi connection.

Keep in mind: If you’re traveling by airplane within or outside the country, you may consider asking your doctor for a note that explains why you are wearing a patch. This may help you when you go through airport security.

Support network questions

If your friend or family member has invited you to view their information on the MYCITE Dashboard, it means they’re asking you to support them and be a part of their treatment plan with the ABILIFY MYCITE System.

They may invite you to view some or all of the following data: when they take their medicine, activity level, time spent resting, their mood, how well they rested, or the reason, if they didn’t take their pill. You may be able to view some of these, or all of these.

It might be a good idea to talk to them about how they want to include you and what they want you to do with their data. Learn more about the dashboard here.

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

The ABILIFY MYCITE System is not intended for real-time or emergency monitoring.

 

Your friend or family member who has been prescribed the ABILIFY MYCITE System will invite you to connect with them using your email address. You will receive a registration email to create an account for the MYCITE Dashboard. On the portal, you will be asked for information like your first and last names, your email address, and a unique password (this information can be updated at any time). After you create your account, you will be able to see what your friend or family member has decided to share with you (pill-taking, activity, rest, mood, rest quality) through the MYCITE Dashboard.

Learn more about the setup process here.

The MYCITE Team is here to help with any technical questions you may have.

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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.