Get your patients started on the ABILIFY MYCITE® System

If you and your patient decide that the ABILIFY MYCITE System is right for them, here’s how to start the prescription process.
Get your patients started on the ABILIFY MYCITE® System
Illustrative data.
Not from a real patient. Not a real patient.
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Is my patient covered?

The cost of an ABILIFY MYCITE® Kit depends on what kind(s) of health insurance your patient has.

Commercial plans

Eligible patients may pay as little as $5/month for an ABILIFY MYCITE Kit through an instant copay program.*

Medicaid

Most Medicaid plans also cover the ABILIFY MYCITE Kit with prior authorization from your state’s Medicaid plan.

Medicare

For patients who are covered under Medicare and qualify for Low Income Subsidy (LIS), copays for brand-name products are $9.85/month or less.1†

The MYCITE® Team is here to provide you and your patients with cost and coverage information about the ABILIFY MYCITE Kit. Call 844‑MYCITE‑3 (844‑692‑4833) for more information.

*
Offer not valid under Medicare, Medicaid, or other federal or state programs. Further conditions apply. Contact the specialty pharmacy for more information.
†
Verified October 25, 2021.
This resource is provided for informational purposes only and is not intended as reimbursement or legal advice. It does not guarantee that coverage and reimbursement will result. Providers should seek independent, qualified professional advice to ensure that their organization is in compliance with the complex legal and regulatory requirements governing healthcare services, and that treatment decisions are made consistent with the applicable standards of care.

Get familiar with the prescription process

Dashboard

Before you prescribe an ABILIFY MYCITE Kit for your patient, you need to create an account for the MYCITE® Dashboard. During setup, the dashboard will assign you a unique connection code that is sent to the patient on the App Setup Card included in the ABILIFY MYCITE® Starter Kit. The patient then enters your connection code in the app to start sharing data with you.

You can also invite others in your practice who are part of the patient's care team to set up their own dashboard accounts. Make sure each member shares their connection code with the patient, so the patient can enter it in the app and start sharing data with the other team members. 

Prescribe

You can prescribe an ABILIFY MYCITE Kit by faxing in the prescription form or by using your electronic health record (EHR) platform. To fax the prescription, download and complete the prescription form. Downloaded forms should be faxed to 844-9-MYCITE (844-969-2483). The specialty pharmacy will verify the patient's insurance coverage (may require a prior authorization).

Download Rx Form  Recommended dosing in adults

If you’re prescribing through your EHR platform, make sure to choose Orsini Pharmaceutical Services, Elk Grove Village, IL 60007 (NPI# 1073608998) as the pharmacy.

You can call the MYCITE Team 8 AM to 6 PM central time, Monday through Friday, if you have any questions: 844-MYCITE-3 (844-692-4833); press 4 for pharmacy.

Shipment

Once coverage is approved and the patient has provided payment information, the prescription will be filled. The pharmacy will send the kit to your office or the patient’s home with setup instructions. You will get an email when the kit has shipped.

Setup appointment

When you are notified, schedule a setup appointment with the patient to get them started. Alternatively, the patient can set up at home with support from the MYCITE Team.

The ABILIFY MYCITE Starter Kit contains a 30-day supply of ABILIFY MYCITE® (aripiprazole tablets with sensor) and MYCITE® Patches (1 reusable pod and 7 disposable adhesive strips). The ABILIFY MYCITE® Maintenance Kit contains a 30-day supply of ABILIFY MYCITE and 7 disposable adhesive strips.

Setting up the MYCITE Dashboard 

Before you prescribe an ABILIFY MYCITE Kit for your patient, follow these next steps to create an account with the dashboard. 

Create an account

You must create a dashboard account before prescribing the kit.

You can also invite others in your practice who are part of the patient's care team to set up their own dashboard accounts. When everyone on the care team sees the same data, it can make it easier to align on patient status.2 

Get your unique connection code

This code will be generated for you when you finish creating your account. The patient receives the code on the App Setup Card in their ABILIFY MYCITE Starter Kit. Once they enter the code in the app, they start automatically sharing their data with you.

Note: Care-team members will also need to create an account on the dashboard to generate their own unique connection codes. The patient must add these connection codes in the MYCITE® App. 

See patient’s daily data

Once your patient is set up with the system, their data will automatically be shared with you in the MYCITE Dashboard. They can change their permissions, at any time, in their app settings. You will get an email letting you know you’re connected. 

The ABILIFY MYCITE Kit is dispensed exclusively by a specialty pharmacy

The pharmacy will contact you to verify patient coverage and prescription information, as needed, and to arrange shipping. The starter kit can be shipped directly to your office or to the patient’s home.

The pharmacy will use CoverMyMeds®‡ for any prior authorizations. 

Maintenance kits can be shipped to your office or to the patient's home.

Pod replacement shipments are available upon request by calling 844‑MYCITE‑3 (844‑692‑4833).

The specialty pharmacy’s hours of operation are 8 AM to 6 PM central time, Monday through Friday. The pharmacy can be reached by calling 844‑MYCITE‑3 (844‑692‑4833) and pressing 4.

‡
CoverMyMeds is a registered trademark of CoverMyMeds LLC, an independent third-party vendor that is solely responsible for its products and services.

Instructions for Use

Below are quick step-by-step videos designed to walk your patient through the setup for the ABILIFY MYCITE System. You can also watch them here to familiarize yourself with the process. They're available to patients on the MYCITE App and on ABILIFYMYCITE.com.

Applying the MYCITE Patch

Once you have prescribed an ABILIFY MYCITE Kit, your patient should follow your instructions for using the system and for taking ABILIFY MYCITE.

The MYCITE Patch is made up of 2 components:

MYCITE Patch@3xa reusable poda disposable adhesive strip

Your patient should follow the Instructions for Use videos and place the adhesive strip on a flat surface, then attach the pod. The pod will need to be paired only once, at the beginning of treatment.

The MYCITE App will prompt your patient when it's time to change the adhesive strip. Strips should be changed at least weekly, but let your patient know if they need to change strips more frequently. 

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).

When prescribing an ABILIFY MYCITE Kit, make sure your patient follows these Instructions for Use:

DO NOT place the patch in areas where your skin is scraped, cracked, inflamed, or irritated.

DO NOT place the patch in a location that overlaps with the area of the most recently removed patch.

DO NOT dispose of the pod when changing your adhesive strip.

Patient wearing MYCITE® Patch

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 Team is here to support you and your patients.

Learn more
1.
US Dept of Health & Human Services. Centers for Medicare & Medicaid Services. 2022 resource and cost-sharing limits for low-income subsidy (LIS). Accessed August 16, 2022. https://www.cms.gov/files/document/lis-memo.pdf
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 August 16, 2022. https://www.otsuka-us.com/discover/articles-1075
IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY MYCITE® (aripiprazole tablets with sensor)
 

IMPORTANT SAFETY INFORMATION

INDICATIONS

 

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.

 

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.