Why does the ABILIFY MYCITE benifit patients?

By seeing their daily data, your patients have the opportunity to: Be proactive in managing their mental health condition and reaching their treatment goals, Better understand their treatment, see if they’re taking their medication, and have greater insight into their medication ingestion patterns, mood, activity level, and rest, Share their information 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

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. Not actual sizes and not to scale.

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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 amount of time each day that 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 visual scale including depressed, happy, and stressed
Mood contributors, including family/work

Quality of rest, based on
a visual scale

Self-reported energy level, based on a
visual scale

Completion of coping activities, such as an
indoor/outdoor walk

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

Overview

Review your patients' data over time at a glance

Illustrative data. Not from a real patient.

Tap image to zoom.

Medication ingestion

Keep track of when patients take ABILIFY MYCITE

Illustrative data. Not from a real patient.

Tap image to zoom.

Energy level

Review patient-reported energy levels

Illustrative data. Not from a real patient.

Tap image to zoom.

Coping activities

View which coping activities patients are using most frequently

Illustrative data. Not from a real patient.

Tap image to zoom.

Mood

See which moods your patients reported feeling

Illustrative data. Not from a real patient.

Tap image to zoom.

Rest

See how much and when patients are resting

Illustrative data. Not from a real patient.

Tap image to zoom.

Rest quality

See how well patients are resting

Illustrative data. Not from a real patient.

Tap image to zoom.

Activity

View patients’ activity level

Illustrative data. Not from a real patient.

Tap image to zoom.

The MYCITE Dashboard is an online portal for healthcare providers^1,2

You can:

Get insight into
objective data, like
medication-taking
patterns and rest

See snapshot views of patient-reported data, like mood, mood contributors, and energy level

Review daily data and coping activities with your patient to better support their treatment plan

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

Pill status

Patients can keep track of when they take ABILIFY MYCITE

Illustrative data. Not from a real patient.

Tap image to zoom.

Mood

During the daily check-in, patients can choose their mood and mood contributors

Illustrative data. Not from a real patient.

Tap image to zoom.

Rest

At the end of the daily check-in, patients can rate how well they rested

Illustrative data. Not from a real patient.

Tap image to zoom.

Energy level

Patients can record their energy level

Illustrative data. Not from a real patient.

Tap image to zoom.

Coping activities

Patients can learn and utilize coping activities

Illustrative data. Not from a real patient.

Tap image to zoom.

Insights

Patients can use Insights to see charts of their mood, rest quality, and energy level data over time

Illustrative data. Not from a real patient.

Tap image to zoom.

Activity

Patients can view their activity level

Illustrative data. Not from a real patient.

Tap image to zoom.

Overview

Patients can see weekly and monthly views of their data

Illustrative data. Not from a real patient.

Tap image to zoom.

Why the ABILIFY MYCITE System

Benefits for you

Visibility into your patients’ medication-taking patterns and other data may help you^2-4:

Identify factors contributing to nonadherence

Assess treatment response, if adherent

Personalize treatment strategies

Strengthen the therapeutic alliance

Foster a more open dialogue

Engage and empower patients

Review factors likely contributing to patients' moods

Benefits for your patient

By seeing their daily data, your patients have the opportunity to^1,2,5:

in managing their mental health condition and reaching their treatment goals

their treatment, see if they’re taking their medication, and get a look into their medication ingestion patterns, mood, steps, 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

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 30, 2022. https://www.otsuka-us.com/discover/articles-1075

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:10.4088/JCP.16m11252

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

Elenko E, Underwood L, Zohar D. Defining digital medicine. Nat Biotechnol. 2015;33(5):456-461. doi:10.1038/nbt.3222

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

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY MYCITE^® (aripiprazole tablets with sensor)

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.

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.

About the
ABILIFY MYCITE^® System