Rx Item-Rexulti brexpiprazole 0.25Mg Tab 30 By Otsuka America

For: Schizophrenia; Major Depressive Disorder

Rexulti (brexpiprazole) is a serotonin-dopamine activity modulator (SDAM) for the treatment of schizophrenia and the adjunctive treatment of major depressive disorder. REXULTI- brexpiprazole tablet
Otsuka America Pharmaceutical, Inc.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

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. REXULTI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].



Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behaviors in patients aged 24 years and younger in short-term studies. Monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors. The safety and efficacy of REXULTI have not been established in pediatric patients [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4)].

1 INDICATIONS AND USAGE

REXULTI is indicated for:

� Adjunctive treatment of major depressive disorder (MDD) [see Clinical Studies (14.1) ].
� Treatment of schizophrenia [see Clinical Studies (14.2) ].
2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

2.3 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)].

2.4 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)].

2.5 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

RX ITEM-Rexulti 0.25Mg Tab 30 By Otsuka
Rexulti brexpiprazole 0.25Mg Tab 30 By Otsuka America item No.:RX422175 NDC No.59148003513 UPC No.:359148035130 NDC No. 59148-0035-13 5914803513 59148-035-13 5914803513 UPC/GTIN No. 3-59148-03513-0 3

Rexulti 0.25Mg Tab 30 By Otsuka America
BRAND: REXULTI NDC: 59148-0035-13,59148003513 UPC: 3-59148-03513-0,359148035130 Otsuka America

BREXPIPRAZOLE ORAL TABLET
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