ABILIFY MYCITE KIT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ABILIFY MYCITE KIT (ABILIFY MYCITE KIT).
Aripiprazole is a partial agonist at D2 and D3 dopamine receptors and 5-HT1A serotonin receptors, and an antagonist at 5-HT2A serotonin receptors. It also exhibits moderate affinity for histamine H1 receptors and alpha1-adrenergic receptors. The MyCite kit includes a sensor that detects tablet ingestion and transmits data to a wearable patch.
| Metabolism | Aripiprazole is metabolized primarily by CYP2D6 and CYP3A4. The major active metabolite is dehydro-aripiprazole (formed by CYP2D6). Phase I reactions include dehydrogenation and hydroxylation. Phase II glucuronidation of hydroxylated metabolites occurs. |
| Excretion | Aripiprazole: ~25% renal, ~55% fecal; unchanged drug accounts for <1% renal. Dehydro-aripiprazole (active metabolite): excreted similarly. |
| Half-life | Aripiprazole: 75 hours (range 48–146 h). Dehydro-aripiprazole: 94 hours (range 48–206 h). Steady state reached in 14 days. |
| Protein binding | Aripiprazole: >99% bound to albumin and alpha-1-acid glycoprotein. Dehydro-aripiprazole: >99% bound. |
| Volume of Distribution | Aripiprazole: 4.9 L/kg (IV). High Vd indicates extensive tissue distribution. |
| Bioavailability | Oral: 87% (absolute). Tablet and orally disintegrating tablet are bioequivalent. |
| Onset of Action | Oral: 1–3 weeks for antipsychotic effect; 1–2 weeks for mood stabilization. |
| Duration of Action | Oral: 24+ hours due to long half-life; once-daily dosing maintains therapeutic levels. |
| Molecular Weight | 448.4 |
| Action Class | Atypical antipsychotic; dopamine-serotonin system stabilizer |
Oral: 10-15 mg once daily; dose range 5-30 mg/day; titrate based on response and tolerability. The MYCITE sensor is applied to the tablet; the patch and app are for adherence monitoring only.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (CrCl ≥15 mL/min). Not recommended for severe renal impairment (CrCl <15 mL/min) due to lack of data. |
| Liver impairment | Child-Pugh Class A or B: No dose adjustment necessary. Child-Pugh Class C: Use with caution; maximum dose 10 mg/day due to increased exposure. |
| Pediatric use | Not approved for patients <18 years; safety and effectiveness not established. |
| Geriatric use | No specific dose adjustment; use lower starting doses (e.g., 5 mg/day) due to increased sensitivity and risk of adverse effects, especially orthostatic hypotension and tardive dyskinesia. |
| 1st trimester | Aripiprazole crosses the placenta. Limited human data; risk of neural tube defects and other malformations cannot be excluded. Use only if benefit outweighs risk. |
| 2nd trimester | Monitor for gestational diabetes and excessive weight gain. May increase risk of preterm delivery. Consider dose adjustments due to physiological changes. |
| 3rd trimester | Risk of extrapyramidal symptoms and withdrawal in neonate. Consider tapering before delivery if possible. |
Clinical note
Comprehensive clinical and safety monograph for ABILIFY MYCITE KIT (ABILIFY MYCITE KIT).
| Placental transfer | Aripiprazole crosses the placenta; fetal plasma concentrations are approximately 50% of maternal levels. |
| Breastfeeding | Aripiprazole is excreted in human milk. Relative infant dose is ~1% of maternal weight-adjusted dose. Monitor infant for somnolence, irritability, and poor feeding. Breastfeeding is considered compatible if benefits outweigh risks. |
■ FDA Black Box Warning
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. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
| Common Effects | Nausea, Vomiting, Constipation, Headache, Dizziness, Akathisia, Insomnia, Anxiety, Somnolence, Tremor, Fatigue, Increased appetite, Weight gain, Dry mouth, Blurred vision |
| Serious Effects | Increased mortality in elderly patients with dementia-related psychosis, Suicidal thoughts or behaviors, Neuroleptic malignant syndrome, Tardive dyskinesia, Stroke and transient ischemic attack in elderly dementia patients, Seizures, Hyperglycemia and diabetes mellitus, Dyslipidemia, Weight gain, Orthostatic hypotension, Leukopenia, neutropenia, agranulocytosis, QT prolongation, Priapism, Body temperature dysregulation, Esophageal dysmotility and aspiration |
Hypersensitivity to aripiprazole or any excipientsConcurrent use of strong CYP3A4 inducers (e.g., carbamazepine)
| Precautions |
Loading safety data…
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | First trimester: Limited human data; animal studies show developmental toxicity (reduced fetal weight, delayed ossification) at doses similar to human exposure. Second/third trimester: Neonates exposed to antipsychotics (including aripiprazole) during late pregnancy may experience extrapyramidal symptoms and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder). |
| Fetal Monitoring | Monitor maternal weight, blood pressure, glucose tolerance, and psychiatric status. Fetal monitoring: consider third-trimester ultrasound for growth, and neonatal monitoring for extrapyramidal symptoms and withdrawal after delivery. |
| Fertility Effects | Aripiprazole may increase serum prolactin levels, potentially causing galactorrhea, amenorrhea, or gynecomastia, and may impair fertility in women and men. Animal studies show no direct impairment of fertility at clinically relevant doses. |
| Neuroleptic malignant syndrome, Tardive dyskinesia, Metabolic changes including hyperglycemia/diabetes, dyslipidemia, weight gain, Orthostatic hypotension, Falls, Leukopenia/neutropenia/agranulocytosis, Seizures, Body temperature regulation impairment, Dysphagia, Suicidal thoughts/behaviors in adolescents/young adults with MDD |
| Food/Dietary | No specific food interactions are reported for the sensor component. Aripiprazole can be taken with or without food. However, avoid excessive alcohol consumption as it may increase central nervous system depression or worsen side effects. Grapefruit and grapefruit juice do not significantly interact with aripiprazole metabolism (CYP3A4 minor pathway); no restriction needed. |
| Clinical Pearls | Abilify MyCite is aripiprazole tablets embedded with an ingestible sensor (Ingestible Event Marker, IEM) that communicates with a wearable patch to record medication ingestion. It is used for schizophrenia, bipolar I disorder, and as adjunctive therapy for major depressive disorder. The sensor does not monitor drug levels or efficacy; it only confirms ingestion. Ensure the patient has a compatible smartphone and the MyCite app. The patch must be replaced weekly. Avoid MRI, CT, or diathermy near the patch; remove if undergoing these procedures. Monitor for aripiprazole side effects: akathisia, metabolic changes, tardive dyskinesia, and neuroleptic malignant syndrome. The ingestible sensor contains copper, magnesium, and silicon; allergy risk is low but possible. |
| Patient Advice | Take Abilify MyCite by mouth as directed. The sensor in the tablet activates upon contact with stomach fluid. Wear the MyCite patch on your left upper abdomen, replacing it weekly. Use the MyCite app to scan the tablet's QR code and confirm ingestion. Do not crush or chew the tablet. If a dose is missed, take it as soon as remembered unless it is close to the next dose. Do not double doses. · The patch is not MRI compatible; remove it before any MRI, CT scan, or diathermy procedure. Inform all healthcare providers that you use this system. The patch contains no latex. You may feel a mild sensation when the patch communicates with your phone. Keep your phone nearby (within Bluetooth range) for recording. · Common side effects of aripiprazole include nausea, vomiting, constipation, headache, dizziness, insomnia, restlessness, and weight gain. Seek medical attention for severe muscle stiffness, fever, confusion, irregular heartbeat, or suicidal thoughts. Avoid alcohol and activities requiring mental alertness until you know how this medication affects you. · The ingestible sensor is generally safe, but if you have a sensitivity to copper, magnesium, or silicon, discuss with your doctor. The patch may cause skin irritation; if it persists, stop use and contact your provider. · Do not rely solely on the app to confirm ingestion; it is not a substitute for clinical judgment. Store tablets at room temperature, away from moisture and heat. Keep out of reach of children. |