Abilify MyCite is a prescription treatment that merges the medication aripiprazole with a digital tracking system. As the first “digital pill” approved by the U.S. Food and Drug Administration (FDA), it provides an objective way to confirm if a patient has taken their medication. This system is designed for adults with specific mental health conditions, giving patients and their healthcare providers information about medication ingestion patterns to help manage treatment.
The Components of the Abilify MyCite System
The Abilify MyCite system integrates three parts that work together. The first is the pill, which contains the antipsychotic medication aripiprazole and an ingestible event marker (IEM) sensor. This sensor is about the size of a grain of sand, made from ingredients found in food like silicon, copper, and magnesium, and has no battery or antenna. It remains inert until it comes into contact with stomach fluid.
Once ingested, the stomach’s acidic environment activates the sensor, causing it to generate a faint electrical signal. This signal is detected by the second component: the MyCite Patch. The patch is a wearable sensor, similar to a small bandage, worn on the torso. It receives the signal from the pill, confirming ingestion and recording the date and time.
The final piece is the MyCite App, a smartphone application that communicates with the patch via Bluetooth. The patch transmits ingestion data and other information, like activity levels, to the app. Patients use the app to view their medication patterns.
Therapeutic Purpose and Indications
The Abilify MyCite system provides an objective record of medication adherence that patients and their healthcare teams can use to inform treatment discussions. While the system tracks ingestion, studies have not shown that it improves patient compliance with a medication regimen. The system is not intended for tracking medication intake in real-time or for use in emergencies, as detection can be delayed.
The FDA has approved Abilify MyCite for specific conditions in adults. It is indicated for the treatment of schizophrenia. The system is also approved for the acute treatment of manic and mixed episodes associated with bipolar I disorder, either as a standalone therapy or with lithium or valproate. It is also used as an add-on treatment for major depressive disorder.
The system is not approved for treating dementia-related psychosis in elderly patients due to an increased risk of serious side effects. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.
Data Collection and Privacy Management
The Abilify MyCite system collects data on medication adherence and patient activity. The patch logs the date and time of ingestion and gathers information on activity levels. Through the MyCite App, patients can also voluntarily input other health information, such as their mood and how well they have rested.
The patient maintains control over their personal health information through the MyCite App. From the app, patients can view all collected data and have the sole authority to decide whether to share it. Access can be granted to a healthcare provider through a secure web-based portal, as well as up to four other individuals like family members. The patient manages this access and can revoke it at any time.
Practical Use and Considerations
The MyCite Patch must be worn continuously for the system to function. It is typically placed on the left or right side of the body just above the rib cage. The patch’s location should be changed with each new application to avoid placing it on the same spot consecutively.
The patch can be worn during daily activities like showering and swimming and must be replaced approximately every seven days. Some users may experience skin irritation from the patch’s adhesive; in clinical studies, about 12.4% of participants reported skin rashes at the application site. If irritation occurs, the patch should be removed.
The system may not register a dose even if the pill was swallowed. Detection can take up to two hours or, in some instances, may not happen at all. If the app does not confirm an ingestion, the patient should not take another dose of the medication.