Rexulti Dosage/Direction for Use

Administration Information: Administer Brexpiprazole (Rexulti) orally, once daily with or without food (see Pharmacology: Pharmacokinetics under Actions).
Recommended Dosage for Adjunctive Treatment of Major Depressive Disorder (Adults): The recommended starting Brexpiprazole (Rexulti) dosage for the adjunctive treatment of MDD in adults is 500 mcg or 1 mg once daily (see Pharmacology: Pharmacokinetics under Actions).
Titrate to 1 mg once daily, then titrate to the target dosage of 2 mg once daily (based on the patient's clinical response and tolerability, increase the dosage at weekly intervals). The maximum recommended daily dosage is 3 mg.
Periodically reassess to determine the continued need and appropriate dosage for treatment.
Recommended Dosage for Schizophrenia (Adults and Pediatric Patients 13 to 17 Years): Adults: The recommended starting dosage for Brexpiprazole (Rexulti) for the treatment of schizophrenia in adult is 1 mg once daily on Days 1 to 4 (see Pharmacology: Pharmacokinetics under Actions).
Titrate to 2 mg once daily on Day 5 through Day 7. On Day 8, the dosage can be increased to the maximum recommended daily dosage of 4 mg based clinical response and tolerability. The recommended target dosage is 2 mg to 4 mg once daily.
Pediatric Patients (13 to 17 years of age): The recommended starting dosage for Brexpiprazole (Rexulti) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age is 0.5 mg once daily on Days 1 to 4, taken orally with or without food (see Pharmacology: Pharmacokinetics under Actions). Titrate to 1 mg once daily on Day 5 through Day 7, then to 2 mg on Day 8 based on the patient's clinical response and tolerability. Weekly dose increases can be made in 1 mg increments. The recommended target Brexpiprazole (Rexulti) dosage is 2 mg to 4 mg once daily. The maximum recommended daily dosage is 4 mg.
Recommended Dosage for Agitation Associated with Dementia Due to Alzheimer's Disease: The recommended starting Brexpiprazole (Rexulti) dosage for the treatment of agitation associated with dementia due to Alzheimer's disease is 0.5 mg taken once daily on Days 1 to 7. Increase the dosage on Days 8 through 14 to 1 mg once daily, and on Day 15 to 2 mg once daily. The recommended target dose is 2 mg once daily. The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, based on clinical response and tolerability.
Recommended Dosage in Patients with Hepatic Impairment: The maximum recommended dosage in patients with moderate to severe hepatic impairment (Child-Pugh score ≥7) is [see Hepatic Impairment under Precautions, Pharmacology: Pharmacokinetics under Actions]. 2 mg once daily for patients with MDD or agitation associated with dementia due to Alzheimer's disease, and 3 mg once daily in patients with schizophrenia (see Renal Impairment under Precautions, Pharmacology: Pharmacokinetics under Actions).
Recommended Dosage in Patients with Renal Impairment: The maximum recommended dosage in patients with creatinine clearance CrCl <60 mL/minute) is [see Renal Impairment under Precautions, Pharmacology: Pharmacokinetics under Actions].
2 mg orally once daily in patients with MDD or agitation associated with dementia due to Alzheimer's disease and 3 mg orally once daily in patients with schizophrenia.
Dosage Modifications for CYP2D6 Poor Metabolizers and for Concomitant use with CYP Inhibitors or Inducers: Dosage modifications are recommended in patients who are known cytochrome P450 (CYP) 2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors, CYP2D6 inhibitors, or strong CYP3A4 inducers (see Table 5).
If the concomitant drug is discontinued, adjust the Brexpiprazole (Rexulti) dosage to its original level. If the concomitant CYP3A4 inducers is discontinued, reduce the Brexpiprazole (Rexulti) dosage to the original level over 1 to 2 weeks [see Drugs Having Clinically Important Interactions with Brexpiprazole (Rexulti) under Interactions, Pharmacology: Pharmacokinetics under Actions]. (See Table 5.)

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Patients with Lactose Intolerance: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be aware that brexpiprazole tablets contain lactose.