Medically reviewed by Drugs.com. Last updated on Feb 10, 2021.
Generic name: brexpiprazole 0.25mg
Dosage form: tablet
Adjunctive Treatment of Major Depressive Disorder
The recommended starting dosage for REXULTI as adjunctive treatment is 0.5 mg or 1 mg once daily, taken orally with or without food [see Clinical Pharmacology (12.3)].
Titrate to 1 mg once daily, then up to the target dosage of 2 mg once daily. Dosage increases should occur at weekly intervals based on the patient's clinical response and tolerability. The maximum recommended daily dosage is 3 mg. Periodically reassess to determine the continued need and appropriate dosage for treatment.
Treatment of Schizophrenia
The recommended starting dosage for REXULTI is 1 mg once daily on Days 1 to 4, taken orally with or without food [see Clinical Pharmacology (12.3)].
The recommended target REXULTI dosage is 2 mg to 4 mg once daily. Titrate to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8 based on the patient's clinical response and tolerability. The maximum recommended daily dosage is 4 mg.
Dosage Adjustments for Hepatic Impairment
For patients with moderate to severe hepatic impairment (Child-Pugh score ≥7), the maximum recommended dosage is 2 mg once daily for patients with MDD, and 3 mg once daily for patients with schizophrenia [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
Dosage Adjustments for Renal Impairment
For patients with moderate, severe or end-stage renal impairment (creatinine clearance CLcr<60 mL/minute), the maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia [see Use in Specific Populations (8.8), Clinical Pharmacology (12.3)].
Dosage Modifications for CYP2D6 Poor Metabolizers and for Concomitant Use with CYP Inhibitors or Inducers
Dosage adjustments are recommended in patients who are known cytochrome P450 (CYP) 2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 1). If the coadministered drug is discontinued, adjust the REXULTI dosage to its original level. If the coadministered CYP3A4 inducer is discontinued, reduce the REXULTI dosage to the original level over 1 to 2 weeks [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
|Factors||Adjusted REXULTI Dosage|
|CYP2D6 Poor Metabolizers|
|CYP2D6 poor metabolizers||Administer half of the usual dose.|
|Known CYP2D6 poor metabolizers taking strong/moderate CYP3A4 inhibitors||Administer a quarter of the usual dose.|
|Patients Taking CYP2D6 Inhibitors and/or CYP3A4 Inhibitors|
|Strong CYP2D6 inhibitors*||Administer half of the usual dose.|
|Strong CYP3A4 inhibitors||Administer half of the usual dose.|
|Strong/moderate CYP2D6 inhibitors with strong/moderate CYP3A4 inhibitors||Administer a quarter of the usual dose.|
|Patients Taking CYP3A4 Inducers|
|Strong CYP3A4 inducers||Double usual dose over 1 to 2 weeks.|
Frequently asked questions
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