Abilify MyCite Maintenance Kit

Abilify MyCite Maintenance Kit, an atypical antipsychotic, is prescribed to manage the following in adults:

• Schizophrenia: Stabilizes hallucinations, delusions, and disordered thinking.
• Bipolar I disorder: Used alone or combined with mood stabilizers to control manic or mixed episodes.
• Major depressive disorder (MDD): Augments antidepressant therapies to alleviate treatment-resistant depression.

Note: Off-label applications may exist beyond those listed here. Consult your healthcare provider for personalized guidance.

Potential adverse reactions

Seek immediate medical attention for:

• Allergic responses: Swelling of facial areas (lips, tongue, throat), hives, breathing difficulties.

Severe complications:

• Intense restlessness, agitation, or distress.
• Uncontrollable muscle movements (eyes, limbs, face).
• Mask-like facial rigidity, speech/swallowing difficulties.
• Seizures, high fever, rigid muscles, irregular heartbeat, or fainting.
• Low blood cell counts (symptoms: fever, bruising, purple skin spots).
• Hyperglycemia signs: excessive thirst, frequent urination, fruity breath odor.

Behavioral changes: Report sudden compulsions (gambling, sexual urges) to your doctor.

Common side effects:

• Tremors, restlessness, or anxiety.
• Digestive issues (nausea, constipation).
• Drowsiness, dizziness, or insomnia.

This list is not exhaustive. Contact your physician for side effect management. Report adverse reactions to the FDA at 1-800-FDA-1088.

Critical safety information

• Dementia-related psychosis: Not recommended for elderly patients due to heightened mortality risks.
• Suicidality: Patients with depression or psychiatric conditions may experience worsening symptoms or suicidal ideation, particularly adolescents starting treatment. Monitor for abrupt mood/behavior changes and seek urgent care if concerns arise.

Additional precautions:

• Avoid alcohol and CNS depressants, which may exacerbate drowsiness.
• Disclose all medications/supplements to prevent interactions.
• Regular monitoring of blood sugar, lipid levels, and weight is advised during therapy.

Precautions and considerations before using this medicine

Avoid Abilify MyCite Maintenance Kit if you have a known hypersensitivity to aripiprazole or its components.

Important safety notice for older adults:

This medication is not approved for elderly patients with dementia-related psychosis due to an elevated risk of mortality.

Notify your doctor if you have previously experienced:

• Cardiovascular conditions (e.g., heart disease, stroke)
• Blood pressure abnormalities (hypertension or hypotension)
• Diabetes (personal or familial)
• Low white blood cell counts (leukopenia/neutropenia)
• Seizure disorders
• Dysphagia (difficulty swallowing)

Mental health monitoring:

• Patients with depression or psychiatric disorders may experience suicidal ideation, particularly adolescents initiating treatment. Vigilantly monitor emotional and behavioral changes, and ensure caregivers remain alert to sudden shifts in mood or actions.

Blood sugar management:

• Aripiprazole may elevate blood glucose levels. If diabetic, conduct regular glucose monitoring and adjust management plans as needed.

Pregnancy and breastfeeding:

• Third-trimester use: Antipsychotic use late in pregnancy may pose risks to newborns, such as withdrawal symptoms or complications. Notify your provider immediately if pregnancy occurs; do not discontinue medication without guidance.
• Pregnancy registry: Participation in a registry may be required to track fetal outcomes.
• Lactation: Consult your doctor about breastfeeding risks, as drug transfer through breast milk is possible.

Administration guidelines

Schizophrenia

• Initial dosage: 10 or 15 mg once daily
• Usual range: 10-15 mg/day
• Maximum dosage: 30 mg/day

Bipolar I disorder

• Monotherapy: 15 mg once daily initially
• Adjunctive to lithium or valproate: 10-15 mg/day initially
• Target dose: 15 mg daily
• Maximum dosage: 30 mg/day

Major depressive disorder (adjunctive treatment)

• Initial dosage: 2-5 mg daily
• Recommended range: 2-15 mg daily
• Dosage adjustments: Up to 5 mg daily, at intervals of no less than one week
• Maximum dosage: 15 mg/day

Follow your prescriber’s instructions precisely. Dosage adjustments may occur during treatment.

Abilify MyCite system

This integrated drug-device system includes:

1. Sensor-embedded tablet: Ingestible pill containing a digital sensor.
2. Wearable patch: Adheres to the skin, detecting signals from the tablet post-ingestion.
3. Mobile app: Records dosing times, activity levels, sleep patterns, and mood data.
4. Healthcare portal: Shares app-generated insights with your medical team.

Usage protocol:

• Detection timeline: The patch typically identifies the tablet within 30 minutes. If undetected, do not take an extra dose.
• Data synchronization: App/portal updates may take ≥2 hours.
• Dosing: Take with or without food, as directed.

Additional instructions:

• Swallow tablets whole; do not crush, chew, or split.
• Attend regular medical evaluations to assess treatment efficacy and safety.
• Store at 68°F–77°F (20°C–25°C), avoiding moisture and heat.

Missed doses and overdose risks

If you forget a dose, take it promptly unless your next scheduled dose is imminent.

Overdose symptoms

In case of suspected overdose, contact emergency services or the Poison Control hotline at 1-800-222-1222 immediately. Symptoms may include:

• Extreme drowsiness or confusion
• Vomiting, tremors, or uncharacteristic aggression
• Irregular heart rhythms (too fast or slow)
• Seizures, fainting, or loss of consciousness
• Labored breathing or coma

Precautions

• Activity restrictions: Avoid driving, operating machinery, or engaging in risky tasks until you understand how the medication affects your alertness. Drowsiness or dizziness increases fall risks.
• Temperature sensitivity: This medication may impair your body’s ability to regulate heat. Avoid prolonged heat exposure, stay hydrated, and monitor for signs of overheating (e.g., excessive sweating, fatigue) during exercise or hot weather.

Action steps:

• Disclose all current medications to your prescriber.
• Consult your doctor before starting or stopping any new treatments.

Does Abilify MyCite interact with my other drugs?

Yes, Abilify MyCite (aripiprazole with a sensor) can interact with other medications, potentially altering its effectiveness or increasing side effects. Key interactions include:

• Antidepressants/antipsychotics: Drugs like fluoxetine (Prozac) or quetiapine (Seroquel) may raise aripiprazole levels, intensifying drowsiness or metabolic changes.
• Blood pressure medications: May amplify dizziness or low blood pressure when combined.
• CYP3A4/CYP2D6 enzyme modifiers: Medications like carbamazepine (Tegretol) or paroxetine (Paxil) can speed up or slow down aripiprazole metabolism, requiring dose adjustments.
• Sedatives or alcohol: May worsen drowsiness or impair coordination.

Combining Abilify MyCite with other substances can alter its effectiveness or trigger adverse reactions. Key considerations:

• Pharmacokinetic interactions: Some medications may raise or lower aripiprazole blood levels, heightening side effects or reducing therapeutic benefits.
• Scope of substances: Includes prescribed drugs, supplements, vitamins, and herbal remedies.

Always inform your doctor about all prescriptions, over-the-counter drugs, supplements, or herbal products you use. Never start, stop, or adjust doses without medical guidance.

Questions and answers

How does Abilify MyCite work?

Abilify MyCite contains aripiprazole, an atypical antipsychotic that stabilizes dopamine and serotonin activity in the brain to manage symptoms of schizophrenia, bipolar disorder, or depression. The embedded sensor tracks ingestion, transmitting data via a wearable patch to a smartphone app, helping monitor adherence.

How do Abilify and Abilify Maintena differ?

Abilify refers to the standard oral tablet taken daily, while Abilify Maintena is a long-acting monthly injectable formulation. Abilify MyCite adds a sensor to the oral tablet for adherence tracking, unlike the non-sensor versions.

Why should you take aripiprazole in the morning?

Aripiprazole may cause restlessness or insomnia in some patients. Taking it in the morning aligns with natural wakefulness cycles, reducing sleep disruption. Your doctor may adjust timing based on side effects.

Does Abilify cause weight gain?

Weight gain is possible but less common compared to other antipsychotics. Risk factors include dosage, duration, and individual metabolism. Monitor diet, exercise, and discuss concerns with your provider to manage changes.

Sources

1. Otsuka America Pharmaceutical, Inc. (2025). Abilify MyCite Maintenance Kit (aripiprazole tablets with sensor): Prescribing Information. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e8787c3f-5e41-42d1-8091-44b56346620f
2. Food and Drug Administration. (2017). Clinical Review: Abilify MyCite (aripiprazole + MIND1 system) NDA 207202. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207202Orig1s000MedR.pdf
3. European Medicines Agency. (2020). Abilify MyCite: EPAR – summary for the public. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/abilify-mycite
4. StatPearls Publishing. (2024). Aripiprazole – StatPearls [Internet]. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK547739/
5. National Institute for Health and Care Excellence (NICE). (2020). Abilify MyCite (aripiprazole with sensor) for bipolar disorder and schizophrenia: Health Technology Briefing. Retrieved from https://www.io.nihr.ac.uk/wp-content/uploads/2022/01/24348-TSID_10351-Abilify-MyCite-for-Bipolar-and-Schizophrenia-v1.0-JUN2020-NON-CONF.pdf
6. de Miguel Beriain, I. (2020). ‘Digital pills’ for mental diseases: an ethical and social analysis of the first FDA‐approved smart drug. Journal of Law and the Biosciences, 7(1), lsaa040. Retrieved from https://academic.oup.com/jlb/article/7/1/lsaa040/5857113
7. National Center for Biotechnology Information (NCBI). (2023). Real-World Evidence of Aripiprazole Tablets with Sensor: Treatment Patterns in a US Commercially Insured Population. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC10292208/