About the ABILIFY MYCITE® System

Meet the first FDA-approved digital medicine system. It captures robust objective and patient-reported data to help encourage communication among care-team members and creates opportunities for more personalized treatment decisions.1,2
ABILIFY MYCITE® Starter Kit
ABILIFY MYCITE® Starter Kit

ABILIFY MYCITE® (aripiprazole tablets with sensor) has not been shown to improve patient compliance or for use in modifying aripiprazole dosage. It should not be used in “real-time” or during an emergency, because detection may be delayed or not occur.

What the ABILIFY MYCITE System does

The system combines wearable and ingestible sensors, smartphone technology, and patient-reported experiences to record a combination of1:

Objective Data

Date and time of ingestion
of ABILIFY MYCITE

Steps taken and miles
walked every 24 hours

Extended periods of time when a patient’s body is resting in a flat position up to an angle of 30°

Patient-reported data

Self-reported data, based on a
7-point visual scale from
1 (angry) to 7 (excited)

Quality of rest, based on 
a 5-point visual scale

Self-reported reasons for missing a dose:

  • I didn't feel like it
  • I forgot
  • I couldn't
  • I took it after midnight
  • I took my tablet but it did not register on the app

You can set up missed-dose notifications, choosing from predetermined criteria, including if the patient has missed multiple or consecutive doses.

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

Use data-driven insights captured by the ABILIFY MYCITE System to help inform treatment decisions.1

Explore the MYCITE® Dashboard

Get a more complete view of what’s happening between appointments, with the MYCITE Dashboard.1

MYCITE® Dashboard medication ingestion view

Illustrative data. Not from a real patient.

Review patients’ medication ingestion at a glance

MYCITE® Dashboard: Patient mood data

Illustrative data. Not from a real patient.

Review patient-reported mood

MYCITE® Dashboard: Patient rest quality

Illustrative data. Not from a real patient.

See rest and patient-reported rest quality

MYCITE® Dashboard: Patient activity level

Illustrative data. Not from a real patient.

View activity level

The impact of the ABILIFY MYCITE System on treatment adherence has not been demonstrated. Some factors, such as connectivity, transmitter malfunction, or device availability, may impact the consistency and reliability of data detection, collection and transmission. Only functions related to tracking drug ingestion have been evaluated or approved by FDA.

The MYCITE Dashboard is an online portal for healthcare providers1

You can:

Smartphone with question mark, Icon
View weekly or monthly ingestion data and reasons for missed doses
Desktop with check mark, Icon
Set up optional email or text notifications for when patients miss multiple or consecutive doses
Calendar, Icon
Review weekly or monthly activity and patient-reported rest and mood, if the patient chooses to share

By looking at the same set of patient data in the MYCITE Dashboard, healthcare providers are able to align on objective data and patient-reported information with other care-team members.1

Set up alerts for missed doses

Only with the MYCITE Dashboard can you choose to set up alerts for your patients’ missed doses

MYCITE® Dashboard: Missed dose alert

You will be able to:

  • Customize how often you want notifications for missed doses
  • See the reason your patients selected for missing a dose. They can choose:
    • I didn’t feel like it
    • I forgot
    • I couldn’t
    • I took it after midnight
    • I took my tablet but it did not register on the app

Knowing additional information regarding missed doses can help guide the conversation with patients and help inform their treatment plan.1

Although most ingestions will be detected within 30 minutes, it may take up to two hours to detect the ingestion of ABILIFY MYCITE; in some cases, tablet ingestion may not be detected. If this occurs, patients should be told not to repeat the dose.

The ABILIFY MYCITE System is not intended for real-time or emergency monitoring because detection may be delayed or not occur.

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

Explore the MYCITE® App

Patients can stay on top of their treatment, with the MYCITE App.

MYCITE® App: Tablet Status view

Illustrative data. Not from a real patient.

Keep track of when they take ABILIFY MYCITE

MYCITE® App: Mood & Rest view

Illustrative data. Not from a real patient.

See how they rated their mood and how well they rested

MYCITE® App: Activity view

Illustrative data. Not from a real patient.

Check their activity level

MYCITE® App: Weekly view

Illustrative data. Not from a real patient.

See weekly and monthly  views of their data

The impact of the ABILIFY MYCITE System on treatment adherence has not been demonstrated. Some factors, such as connectivity, transmitter malfunction, or device availability, may impact the consistency and reliability of data detection, collection and transmission. Only functions related to tracking drug ingestion have been evaluated or approved by FDA.

Why the ABILIFY MYCITE System

Benefits for you

Visibility into your patients’ medication-taking patterns and other data may help you­2-4:

Magnifying glass, Icon
Identify factors contributing to nonadherence
 
Clipboard with checkmark, Icon
Assess treatment response, if adherent
Person with star, Icon
Personalize treatment strategies
Bicep flexing, Icon
Strengthen the therapeutic alliance
Conversation bubbles, Icon
Foster a more open dialogue
Person, Icon
Engage and empower patients

Benefits for your patient

By seeing their daily data, your patients have the opportunity to1,2,5:

in managing their mental health condition and reaching their treatment goals

their treatment, see if they’re taking their medication, and have greater insight into their medication ingestion patterns, mood, activity level, and rest

with their care team and support network so patients:

  • Don’t have to remember everything that has happened between appointments
  • Stay connected throughout their treatment

The impact of the ABILIFY MYCITE System on treatment adherence has not been demonstrated. Some factors, such as connectivity, transmitter malfunction, or device availability, may impact the consistency and reliability of data detection, collection and transmission. Only functions related to tracking drug ingestion have been evaluated or approved by FDA.

The ABILIFY MYCITE System gives patients more ways to connect to their care team and support network. When everyone is working with the same information, it can help reduce uncertainty and foster trust.1,2

Which of your patients are appropriate for the ABILIFY MYCITE System?

Find out
Not a real patient.
1.
Otsuka and Proteus® announce the first U.S. FDA approval of a digital medicine system: ABILIFY MYCITE® (aripiprazole tablets with sensor). News release. Otsuka America Pharmaceutical, Inc. November 14, 2017. Accessed November 24, 2020. https://www.otsuka-us.com/discover/articles-1075
2.
Hatch A, Docherty JP, Carpenter D, Ross R, Weiden PJ. Expert consensus survey on medication adherence in psychiatric patients and use of a digital medicine system. J Clin Psychiatry. 2017;78(7):e803-e812. doi:10.1109/TBME.2014.2341272
3.
Shafrin J, May SG, Shrestha A, et al. Access to credible information on schizophrenia patients’ medication adherence by prescribers can change their treatment strategies: evidence from an online survey of providers. Patient Prefer Adherence. 2017;11:1071-1081. doi:10.2147/PPA.S135957
4.
Elenko E, Underwood L, Zohar D. Defining digital medicine. Nat Biotechnol. 2015;33(5):456-461. doi:10.1089/tmj.2005.11.675
5.
Sawesi S, Rashrash M, Phalakornkule K, Carpenter JS, Jones JF. The impact of information technology on patient engagement and health behavior change: a systematic review of the literature. JMIR Med Inform. 2016;4(1):e1. doi:10.2196/medinform.4514
INDICATIONS and IMPORTANT SAFETY INFORMATION
for ABILIFY MYCITE® (aripiprazole tablets with sensor)

INDICATIONS

ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated in adults for the:

  • Treatment of schizophrenia
  • Treatment of bipolar I disorder as monotherapy and as adjunct to lithium or valproate for:
    • Acute treatment of manic and mixed episodes
    • Maintenance treatment
  • Adjunctive treatment of major depressive disorder

Limitations of Use: ABILIFY MYCITE has not been shown to improve patient compliance or for use in modifying aripiprazole dosage. It should not be used in “real-time” or during an emergency, because detection may be delayed or not occur.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (1.6 to 1.7 times) compared to placebo-treated patients. ABILIFY MYCITE is not approved for the treatment of patients with dementia-related psychosis.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults. Those on antidepressant therapy should be monitored closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. The safety and effectiveness of ABILIFY MYCITE have not been established in pediatric patients.

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with aripiprazole.

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs, including ABILIFY MYCITE. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of ABILIFY MYCITE, intensive symptomatic treatment, and monitoring.

Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible, are believed to increase with duration of treatment and in total cumulative dose of antipsychotic drugs. TD can develop after a relatively brief treatment period, even at low doses, or after discontinuation. If antipsychotic treatment is withdrawn, TD may remit, partially or completely. Prescribing should be consistent with the need to minimize TD.

Metabolic Changes: Atypical antipsychotic drugs have caused metabolic changes including:

  • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics including aripiprazole. Patients with diabetes mellitus should be regularly monitored for worsening of glucose control; those with risk factors for diabetes (e.g., obesity, family history of diabetes), should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
  • Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
  • Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Pathological Gambling and Other Compulsive Behaviors: Intense urges, particularly for gambling, and the inability to control these urges have been reported while taking aripiprazole. Other compulsive urges have been reported less frequently. Prescribers should ask patients or their caregivers about the development of new or intense compulsive urges. Consider dose reduction or stopping ABILIFY MYCITE if such urges develop.

Orthostatic Hypotension: ABILIFY MYCITE may cause orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension.

Falls: Antipsychotics may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls causing fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue ABILIFY MYCITE at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.

Seizures: ABILIFY MYCITE should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: ABILIFY MYCITE may impair judgment, thinking, or motor skills. Instruct patients to avoid operating hazardous machinery, including automobiles, until they are certain ABILIFY MYCITE does not affect them adversely.

Body Temperature Regulation: Use ABILIFY MYCITE with caution in patients who may experience conditions that increase body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics).

Dysphagia: Esophageal dysmotility and aspiration have been associated with ABILIFY MYCITE. Use caution in patients at risk for aspiration pneumonia.

Dosage Adjustments and Cytochrome P450 Considerations: For patients with schizophrenia and bipolar I disorder taking ABILIFY MYCITE who are:

  • Known CYP2D6 poor metabolizers, administer half the recommended dose

  • Known CYP2D6 poor metabolizers taking concomitant strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin), administer a quarter the recommended dose.

  • Taking strong CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) or CYP3A4 inhibitors, administer half the recommended dose.

  • Taking strong CYP2D6 and CYP3A4 inhibitors, administer a quarter the recommended dose. When co‑administered drug is withdrawn, adjust ABILIFY MYCITE dosage to its original level.

  • Taking strong CYP3A4 inducers (e.g., carbamazepine, rifampin), double recommended dose over 1 to 2 weeks. When co‑administered drug is withdrawn, reduce ABILIFY MYCITE dosage to original level over 1 to 2 weeks.

Commonly Observed Adverse Reactions (incidence ≥5% and at least twice that for placebo) in adult patients:

  • Schizophrenia: akathisia

  • Bipolar mania (monotherapy): akathisia, sedation, restlessness, tremor, and extrapyramidal disorder

  • Bipolar mania (adjunctive therapy with lithium or valproate): akathisia, insomnia, and extrapyramidal disorder

  • Major depressive disorder (adjunctive treatment to antidepressant therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision

Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first days of treatment and at low doses.

Skin Irritation for MYCITE Patch: Symptoms of skin irritation localized at the site of the MYCITE Patch may occur. In clinical studies, 12.4% of patients (n=61) experienced skin rashes at the site of patch placement.

Pregnancy: Neonates exposed to antipsychotic drugs, including ABILIFY MYCITE, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Consider the benefits and risks of ABILIFY MYCITE and possible risks to the fetus when prescribing ABILIFY MYCITE to a pregnant woman. Advise pregnant women of potential fetal risk. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ABILIFY MYCITE during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Lactation: Aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, effects on the breastfed infant, or effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for ABILIFY MYCITE and any potential adverse effects on the infant or from the underlying maternal condition.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.