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Abilify Mycite Dosage

Generic name: ARIPIPRAZOLE 2mg
Dosage form: tablet

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Medically reviewed by Drugs.com. Last updated on Feb 14, 2020.

Overview of the ABILIFY MYCITE System

The ABILIFY MYCITE System is composed of the following components:

  • 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;
  • MYCITE APP - a smartphone application (app) which is used with a compatible smartphone to display information for the patient;
  • Web-based portal for healthcare professionals and caregivers

Prior to initial patient use of the ABILIFY MYCITE System, facilitate use of the combination product and its components (patch, app, portal) and ensure the patient is capable and willing to use smartphones and apps. Before using any component of the ABILIFY MYCITE System, instruct patients to:

  • Download the MYCITE APP and follow all the Instructions for Use.
  • Ensure that the app is compatible with their specific smartphone.

Although most ingestions will be detected within 30 minutes, it may take up to two hours for the smartphone app and web portal to detect the ingestion of ABILIFY MYCITE; in some cases, the ingestion of the tablet may not be detected. If the tablet is not detected after ingestion, do not repeat the dose [see Adverse Reactions (6)] .

The status of the MYCITE Patch is indicated by a status icon in the app to inform the user that the patch is properly adhered and fully functioning. Instruct patients to ensure that the app is paired with the patch prior to use. Refer to the information provided in the product packaging and electronic Instructions for Use within the MYCITE APP.

Administration Instructions

ABILIFY MYCITE

Administer ABILIFY MYCITE orally with or without food [see Clinical Pharmacology (12.3)] . Swallow tablets whole; do not divide, crush, or chew.

MYCITE Patch

Apply the MYCITE Patch only when instructed by the app to the left side of the body just above the lower edge of the rib cage. Do not place the MYCITE 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. Instruct patients to keep the patch on when showering, swimming, or exercising. The MYCITE Patch should be changed weekly or sooner as needed. The app will prompt patient to change the patch and will direct patient to apply and remove the patch correctly. Patients undergoing an MRI need to remove their patch and replace with a new one as soon as possible. If there is skin irritation, instruct patients to remove the patch.

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 1 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 co-administered drug is withdrawn from the combination therapy, ABILIFY MYCITE dosage should then be adjusted to its original level. When the co-administered 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.

Table 1: Dose Adjustments for ABILIFY MYCITE in Patients Who Are Known CYP2D6 Poor Metabolizers and Patients Taking Concomitant CYP2D6 Inhibitors, 3A4 Inhibitors, and/or CYP3A4 Inducers
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) ].

Frequently asked questions

Further information

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