Support for the ABILIFY MYCITE® System

These resources are designed to support you and your patients throughout your experience with the ABILIFY MYCITE System.
Hand holding ABILIFY MYCITE® (aripiprazole tablets with sensor) Tablet

Popular questions

Starting your patients on the ABILIFY MYCITE System

ABILIFY MYCITE® (aripiprazole tablets with sensor) is a drug-device combination product consisting of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion.

It 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.

In most cases, an ABILIFY MYCITE Kit can be prescribed by a psychiatrist, psychiatric nurse practitioner, or primary care physician.

The system is covered under many insurance plans. Find more information here.

The ABILIFY MYCITE® Starter Kit includes a 30-day supply of ABILIFY MYCITE and MYCITE Patches (1 reusable pod and 7 disposable adhesive strips). The kit will also include instructions on how to set up the system with the MYCITE® App. If the patient has any questions, they can call their Patient Education Liaison (PEL) at 1-855-242-7787.

The MYCITE Team can answer technical questions about the ABILIFY MYCITE System. You can call the team if you need help troubleshooting the MYCITE® Dashboard or need to contact the specialty pharmacy regarding a patient's prescription and refills.

Once you’ve prescribed an ABILIFY MYCITE Kit, your patient can enroll in our PEL program, and connect with a dedicated nurse. This PEL will provide resources and personalized support throughout the patient's treatment journey. They can help your patient get started on the ABILIFY MYCITE System and can answer questions they may have about their medication, the prescription process, and the MYCITE® App.

Yes. If you have a patient who is currently being treated or was previously treated using the ABILIFY MYCITE System and is interested in sharing their experience, they can call 1-844-815-0984 or email [email protected] to learn more.

About ABILIFY MYCITE (aripiprazole tablets with sensor)

Learn more about the ABILIFY MYCITE System

ABILIFY MYCITE Kits are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths.

Tap to view table.

ABILIFY MYCITE Recommended dosing in adults, Table
  Initial Titration Recommended Maximum
Major depressive disorder
(adjunct to antidepressants)
2-5 mg/day Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week 5-10 mg/day 15 mg/day
Bipolar mania
(monotherapy)
15 mg/day Adjust dose gradually 15 mg/day 30 mg/day
Bipolar mania
(adjunct to lithium or valproate)
10-15 mg/day
Schizophrenia
(monotherapy)
10-15 mg/day Adjust dose gradually; increases should generally not be made before 2 weeks 10-15 mg/day 30 mg/day

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.

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

See additional IMPORTANT SAFETY INFORMATION for ABILIFY MYCITE.

ABILIFY MYCITE is a smart pill with an embedded ingestible event marker (IEM) sensor the size of a grain of sand (1 mm). The sensor technology is made up of natural ingredients found in most diets and leaves the body as waste. The patient should not be able to feel the sensor or the signal it sends.1,2

About the MYCITE Patch

Learn more about the ABILIFY MYCITE System

Symptoms of skin irritation localized at the site of the MYCITE Patch may occur in some patients. In clinical studies of 492 patients, 61 (12.4%) experienced skin rashes localized at the site of patch placement. No serious adverse reactions related to the ingestible sensor were reported in clinical studies.3

These are not all the adverse reactions associated with the ABILIFY MYCITE System. The safety of ABILIFY MYCITE for the treatment of adults with schizophrenia, treatment of adults with manic and mixed episodes associated with bipolar I disorder, and adjunctive treatment of adults with major depressive disorder (MDD) has been established and is based on trials of aripiprazole.

If you have further questions, reach out to your Otsuka representative.

No. The patch is not medicated.

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 paired MYCITE Patch can be applied to the right or left side of the patient’s stomach (area below chest and above their navel). It should not be applied on areas where skin is scraped, cracked, inflamed, or irritated, or in a location that overlaps the area of the most recently removed patch. If there is skin irritation, the disposable adhesive strip should be removed.

All MYCITE Patch materials that contact the skin have been tested and meet appropriate biocompatibility standards. The patch adhesive area consists of hydrogels, hydrocolloids, and acrylic—it is not made with natural rubber latex.

Each reusable pod can be paired once, at setup, and used for up to 1 year. The MYCITE® App will let the patient know when it’s time to change the adhesive strip. Strips should be changed at least weekly, but you can let your patient know if they need to change them more frequently. The patch can stay on through water and sweat and does not need to be taken off in the shower or during exercise.

Technical questions

If a patient has any questions about setting up the ABILIFY MYCITE System, the MYCITE Team will be ready to help them at 844-MYCITE-4 (844-692-4834). The MYCITE Team is available 8 AM to 8 PM eastern time, Monday through Friday. Their dedicated PEL can also walk them through the setup process, step-by-step. PELs are available at 1-855-242-7787, 8 AM to 8 PM eastern time, Monday through Friday, excluding holidays.

The MYCITE Team is here to provide you and your office staff with any support you may need with the ABILIFY MYCITE System. Call the MYCITE Team for more information at 844-MYCITE-3 (844-692-4833).

The ABILIFY MYCITE System is a smart pill combined with a wearable Bluetooth®* patch that captures medication ingestion and objective physiological data, presented in the MYCITE Dashboard with patient-reported data.

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

The ABILIFY MYCITE System is intended to track whether ABILIFY MYCITE has been taken. Approximately 94% of all ingestions are registered by the MYCITE Patch within 3 minutes after ingestion; however, it may take up to 2 hours for the MYCITE App and MYCITE Dashboard to detect ingestion. The patient will usually see the information on their smartphone within 5 minutes. In some cases, tablet ingestion may not be detected. If this occurs, patients should be told not to repeat the dose.4

Some factors, such as connectivity, transmitter malfunction, or device availability may impact the consistency and reliability of data detection, collection, and transmission.

The MYCITE Patch records ingestion of the tablet and other physiological data. It will connect with the MYCITE App once it is within Bluetooth®* range, which is approximately 9 feet. Your patient will need to have access to a regular and reliable internet connection to be able to use the ABILIFY MYCITE System.

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

The MYCITE App 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)

It is advised that patients check their smartphones’ app store or call the MYCITE Team at 844‑MYCITE‑4 (844‑692‑4834) to ensure compatibility with their specific smartphones and operating systems. If patients don't see their device, but it still meets the operating system requirements listed above, they will still likely be able to use the MYCITE App. The MYCITE App is designed to be identical across Android and iOS except where differences are required by the respective operating systems.

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.

The ABILIFY MYCITE System will still work outside the country. Data plan and roaming charges may apply based on the patient’s phone plan and WiFi connection.

When traveling by airplane within or outside of the country, the patient should consider requesting a medical waiver to indicate why they are wearing a patch. Additionally, when going through airport security, the patient may request a pat-down instead of going through the body scanner.

Privacy of the system

Patients can share the daily data in their app with you and other members of their care team. They can also share all or some of their data with anyone else they choose—like family members or close friends.1

Patients can stop sharing all or some of their data at any time, and data are encrypted and stored securely in the cloud, ensuring patient privacy.1

For more information on how your patients' and your information will be used, please read the ABILIFY MYCITE® System Terms of Use, Privacy Notice, and Authorization & Consent.

No. There is no geolocation functionality associated with any element of the ABILIFY MYCITE System.

Get support for the ABILIFY MYCITE System

Our Otsuka representative can help you:

Learn more about the ABILIFY MYCITE System

Request

Request

Our support team can help patients and your office staff with:

  • Questions and technical support
  • Contacting the specialty pharmacy regarding a patient’s prescription and refills
  • Setting up your MYCITE Dashboard

Call us at 844⁠-⁠MYCITE⁠-⁠4 (844⁠-⁠692⁠-⁠4834). We are available 8 AM to 8 PM eastern time, Monday through Friday.

Once you’ve prescribed an ABILIFY MYCITE Kit, your patients can connect with a dedicated nurse for resources and personalized support throughout their treatment journey. This PEL will be their point of contact for:

  • Questions about insurance and the specialty pharmacy process
  • Getting started with the ABILIFY MYCITE System
  • Understanding and using the MYCITE App

Help your patient get enrolled in the PEL program. PELs are available at 1-855-242-7787, 8 AM to 8 PM eastern time, Monday through Friday, excluding holidays.

Downloadable resources

Materials for your practice

Materials for your patient

Patient Recruitment Card, Downloadable Resource

Patient Ambassador Card

Do you have patients using the ABILIFY MYCITE System who would like to inspire others by sharing about their experience? This card explains how they can join our Patient Ambassador Program.

Download /resources-support/patient-ambassador-card
Getting Started with the ABILIFY MYCITE® System, Downloadable Resource

Getting Started with the ABILIFY MYCITE System Brochure

Are you planning to start a patient on the ABILIFY MYCITE System? After you write their prescription, share this brochure with them so they know what to expect before their setup appointment.

Download /resources-support/getting-started-flashcard

Discover how the ABILIFY MYCITE System can provide data-driven insights to help inform treatment decisions.

Learn more
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.
Hafezi H, Robertson TL, Moon GD, Au-Yeung KY, Zdeblick MJ, Savage GM. An ingestible sensor for measuring medication adherence. IEEE Trans Biomed Eng. 2015;62(1):99-109. doi:10.1109/TBME.2014.2341272
3.
Proteus Digital Health Feedback Device. Instructions for use. Proteus Digital Health, Inc; 2018.
4.
Profit D, Rohatagi S, Zhao C, Hatch A, Docherty JP, Peters-Strickland TS. Developing a digital medicine system in psychiatry: ingestion detection rate and latency period. J Clin Psychiatry. 2016;77(9):e1095-e1100. doi:10.4088/JCP.16m10643
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.