Drug Detail:Abilify mycite starter kit (oral with sensor) (Aripiprazole (oral with sensor) [ ar-i-pip-ra-zole ])
Generic Name: ARIPIPRAZOLE 2mg
Dosage Form: tablet
Drug Class: Atypical antipsychotics
Overview of the ABILIFY MYCITE System
The ABILIFY MYCITE System is composed of the following:
- Aripiprazole tablet embedded with an IEM sensor (ABILIFY MYCITE);
- MYCITE® Patch (wearable sensor) that detects the signal from the IEM sensor after ingestion and transmits data to a smartphone (referred to as the patch);
- MYCITE App - a smartphone application which is used with a compatible smartphone to display information for the patient (referred to as the app);
- Web-based portal for healthcare professionals and caregivers
Prior to initial patient use of the ABILIFY MYCITE System, facilitate use of ABILIFY MYCITE and the patch, app, and portal; ensure the patient is capable and willing to use a smartphone and the app; and instruct patients to [see How Supplied/Storage and Handling (16.1)]:
- Download the app,
- Follow all the instructions in the Instructions for Use within the app and the Quick Start Guide within the carton, and
- Ensure that the app is compatible with their specific smartphone and is paired with the patch prior to use.
Prior to prescribing the ABILIFY MYCITE Maintenance Kit ensure the patient has access to the appropriate components of the patch [see How Supplied/Storage and Handling (16.1)].
Although most ingestions will be detected within 30 minutes, it may take up to two hours for the app and portal to detect the ingestion of ABILIFY MYCITE; in some cases, the ingestion of the tablet with sensor may not be detected. If the tablet with sensor is not detected after ingestion, do not repeat the dose [see Adverse Reactions (6)].
Administration Instructions
ABILIFY MYCITE
Administer ABILIFY MYCITE orally with or without food [see Clinical Pharmacology (12.3)]. Swallow tablets with sensor whole; do not divide, crush, or chew.
MYCITE Patch
Refer to the Instructions for Use (IFU) within the app [see How Supplied/Storage and Handling (16.1)]:
- Apply only when instructed by the app to the right or left side of the body just above the lower edge of the rib cage.
Additional patch instructions:
- Do not place the patch in areas where the 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, instruct patients to remove the patch).
- The app will prompt the patient to change the patch (at least weekly or sooner), and to apply and remove the patch correctly.
- Keep the patch on when showering, swimming, or exercising.
- For those undergoing an MRI, remove the patch and replace with a new patch as soon as possible.
Dosage in Schizophrenia
The recommended starting and target dosage for ABILIFY MYCITE in adults with schizophrenia is 10 or 15 mg daily. Dosage increases should generally not be made before 2 weeks [see Clinical Pharmacology (12.3)]. The maximum recommended dosage is 30 mg daily; however, doses above 15 mg daily have shown no additional clinically meaningful benefit.
Dosage in Bipolar I Disorder
The recommended starting dosage in adults with acute and mixed episodes associated with bipolar I disorder is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive treatment with lithium or valproate. The recommended target dose of ABILIFY MYCITE is 15 mg daily, as monotherapy or as adjunctive treatment with lithium or valproate. The dosage may be increased to 30 mg daily based on clinical response. The maximum recommended daily dosage is 30 mg.
Dosage in Adjunctive Treatment of Major Depressive Disorder
The recommended starting dose for ABILIFY MYCITE as adjunctive treatment of adults with MDD taking an antidepressant is 2 to 5 mg daily. The recommended dosage range is 2 to 15 mg daily. Dosage adjustments of up to 5 mg daily should occur gradually, at intervals of no less than one week. The maximum recommended daily dosage is 15 mg. Periodically reassess to determine the continued need for maintenance treatment.
Dosage Adjustments for Cytochrome P450 Considerations
Dosage adjustments are recommended in patients who are known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 1). When the coadministered drug is withdrawn from the combination therapy, ABILIFY MYCITE dosage should then be adjusted to its original level. When the coadministered CYP3A4 inducer is withdrawn, ABILIFY MYCITE dosage should be reduced to the original level over 1 to 2 weeks. Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted based on clinical response.
| Factors | Dosage Adjustments for ABILIFY MYCITE |
|---|---|
| Known CYP2D6 Poor Metabolizers | Administer half of recommended dose |
| Known CYP2D6 Poor Metabolizers taking concomitant strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) | Administer a quarter of recommended dose |
| Strong CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) or CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) | Administer half of recommended dose |
| Strong CYP2D6 and CYP3A4 inhibitors | Administer a quarter of recommended dose |
| Strong CYP3A4 inducers (e.g., carbamazepine, rifampin) | Double recommended dose over 1 to 2 weeks |
When adjunctive ABILIFY MYCITE is administered to patients with major depressive disorder, ABILIFY MYCITE should be administered without dosage adjustment as specified in [Dosage and Administration (2.5)].
