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ABILIFY MYCITE- aripiprazole tablet


  1. Patient Information
  2. What Is Abilify Mycite?
  3. What Are The Possible Side Effects Of Abilify Mycite?abilify Mycite May Cause Serious Side Effects, Including:
  4. What Are The Ingredients In Abilify Mycite?active Ingredient:
  5. Inactive Ingredients:
  6. Manufactured By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

General Instructions for Use

Instruct patients to refer to the app store to ensure compatibility with their specific smartphone.

Instruct patient to first download the MYCITE APP and follow instructions provided by the app.

Advise patients that the initial use should be facilitated by the healthcare provider.

Advise patients that most ingestions will be detected within 30 minutes; however, in some cases it can take over two hours for the smartphone app and web portal to detect the ingestion of ABILIFY MYCITE. In some cases, the ingestion of the tablet may not be detected. If the tablet is not detected after ingestion, the dose should not be repeated.

Managing Lost or Disabled Mobile Device

Advise patients that if their smartphone is lost, impaired or otherwise rendered unusable, some information collected by the system (synced) may be lost. Advise patients to change their MYCITE Patch immediately and connect to a new mobile device using their current account information. Information previously synced to the patients account will be available.

Using the MYCITE Patch in Different Environments

The MYCITE Patch will communicate with a paired device when it is within 9 foot proximity. The MYCITE Patch should remain on an individual whether they are showering, swimming, or exercising as it is intended to tolerate water or perspiration. Patients undergoing an MRI, however, need to remove their patch and replace with a new one as soon as possible. In order for the MYCITE Patch to communicate with a smartphone, the device must be powered on and Bluetooth-enabled.

Suicidal Thoughts and Behaviors

Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider[

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

What Is Abilify Mycite? 


ABILIFY MYCITE is a prescription medicine of aripiprazole tablets with an Ingestible Event Marker (IEM) sensor inside it used:
  • To treat adults with schizophrenia
  • To treat bipolar 1 disorder:
    • short-term (acute) treatment of adults with manic or mixed episodes alone or when used with the medicine lithium or valproate
    • maintenance treatment of adults alone or when used with the medicine lithium or valproate
  • To treat adults with major depressive disorder (MDD) along with other antidepressant medicines
The ABILIFY MYCITE System is meant to track if you have taken your ABILIFY MYCITE.
It is not known if ABILIFY MYCITE can improve how well you take your aripiprazole (patient compliance) or for changing your dose of aripiprazole.
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. ABILIFY MYCITE is not for use as real-time or emergency monitoring.
It is not known if ABILIFY MYCITE is safe or effective for use in children.Do not take ABILIFY MYCITE if youare allergic to aripiprazole or any of the ingredients in ABILIFY MYCITE.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY MYCITE affects you. ABILIFY MYCITE may make you drowsy.
    • Do not become too hot or dehydrated during treatment with ABILIFY MYCITE.
      • Do not exercise too much.
      • In hot weather, stay inside in a cool place if possible.
      • Stay out of the sun.
      • Do not wear too much clothing or heavy clothing.
      • Drink plenty of water.

What Are The Possible Side Effects Of Abilify Mycite?abilify Mycite May Cause Serious Side Effects, Including: 

    • Store ABILIFY MYCITE tablets and MYCITE Patches at room temperature, between 68 F to 77 F (20 C to 25 C).
    • Keep ABILIFY MYCITE tablets and MYCITE Patches (wearable sensor) dry. Do not store ABILIFY MYCITE tablets and Patches (wearable sensor) in places with high humidity.
    Keep ABILIFY MYCITE and all medicines out of the reach of children.General information about the safe and effective use of ABILIFY MYCITE.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY MYCITE for a condition for which it was not prescribed. Do not give ABILIFY MYCITE to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ABILIFY MYCITE that was written for healthcare professionals.

What Are The Ingredients In Abilify Mycite?active Ingredient: 

aripiprazole

Inactive Ingredients: 

cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose, and Ingestible Event Marker (IEM). Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate.

Manufactured By: 


Tablets manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan
IEM and Patches Manufactured by Proteus Digital Health, Inc., 2600 Bridge Parkway, Redwood City, CA 94065 USA
Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA
ABILIFY MYCITEand MYCITEare registered trademarks of Otsuka Pharmaceutical Co., Ltd.
2017, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan
For more information about ABILIFY MYCITE go to www.abilifymycite.com or call 1-844-692-4834



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