From the FDA Drug Label
2 DOSAGE AND ADMINISTRATION
2.1 Administration Information Administer brexpiprazole tablets orally, once daily with or without food 2.2 Recommended Dosage for Adjunctive Treatment of Major Depressive Disorder (Adults) The recommended starting brexpiprazole tablets dosage for the adjunctive treatment of MDD in adults is 0.5 mg or 1 mg orally once daily. 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. 2.3 Recommended Dosage for Schizophrenia (Adults) The recommended starting brexpiprazole tablets dosage for the treatment of schizophrenia in adults is 1 mg orally once daily on Days 1 to 4. 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 on clinical response and tolerability The recommended target dosage is 2 mg to 4 mg once daily.
The recommended use and dosage of Rexulti (brexpiprazole) is as follows:
- For adjunctive treatment of Major Depressive Disorder (MDD) in adults:
- Starting dosage: 0.5 mg or 1 mg orally once daily
- Target dosage: 2 mg once daily
- Maximum recommended daily dosage: 3 mg
- For treatment of Schizophrenia in adults:
- Starting dosage: 1 mg orally once daily on Days 1 to 4
- Titrate to 2 mg once daily on Day 5 through Day 7
- Maximum recommended daily dosage: 4 mg
- Target dosage: 2 mg to 4 mg once daily 1
From the Research
Rexulti (brexpiprazole) is recommended for the treatment of schizophrenia in adults, with a target dose of 2-4 mg daily, and as an adjunctive treatment for major depressive disorder (MDD) with a target dose of 2 mg daily. The medication should be initiated at a dose of 1 mg once daily for 4 days, then increased to 2 mg daily for 3 days, with gradual increases to the target dose as needed and tolerated [ 2 ].
Key Considerations
- Dosage adjustments are necessary for patients with moderate to severe liver or kidney impairment, and for those taking strong CYP2D6 or CYP3A4 inhibitors [ 3 ].
- Rexulti works by modulating serotonin and dopamine activity in the brain, helping to stabilize mood and reduce psychotic symptoms [ 4 ].
- Common side effects include weight gain, akathisia (restlessness), and increased risk of suicidal thoughts in young adults [ 5 ].
- The medication should be taken consistently at the same time each day, with or without food, and patients should avoid alcohol while taking it [ 6 ].
Monitoring and Follow-up
Regular follow-up appointments are essential to monitor effectiveness and side effects, with particular attention to weight gain, akathisia, and suicidal thoughts [ 2 ].
Evidence Summary
The recommended use and dosage of Rexulti (brexpiprazole) are based on the most recent and highest quality studies, including a review of brexpiprazole for the treatment of schizophrenia [ 2 ] and a systematic review of the efficacy and safety profile of brexpiprazole [ 5 ]. These studies demonstrate the efficacy and safety of brexpiprazole for the treatment of schizophrenia and as an adjunctive treatment for MDD, with a favorable side effect profile compared to other antipsychotic medications [ 3 ].