From the FDA Drug Label
DOSAGE AND ADMINISTRATION The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40-80 mg daily). The following dosage titration schedule is suggested: 5 mg t.i.d. for 3 days 10 mg t.i.d. for 3 days 15 mg t.i.d. for 3 days 20 mg t.i.d. for 3 days Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).
The recommended dosing for Brexpiprazole is not found in the provided label, as it refers to a different drug, brebreuarda. However, based on the provided label for a different medication, it appears the label is for a medication that is dosed between 40-80 mg daily.
- The dosage titration schedule is:
- 5 mg three times a day for 3 days
- 10 mg three times a day for 3 days
- 15 mg three times a day for 3 days
- 20 mg three times a day for 3 days
- The maximum daily dose should not exceed 80 mg. However, Brexpiprazole (Rexulti) dosing cannot be determined from this label as it is for a different drug. 1
From the Research
The recommended dosing for Brexpiprazole (Rexulti) is 2-4 mg daily for schizophrenia, with a starting dose of 1 mg/day and gradual increase to the target dose, as supported by the most recent and highest quality study 2.
Key Considerations
- The dose should be adjusted for patients taking certain medications, such as CYP2D6 inhibitors, which may require reducing the Rexulti dose by half.
- Patients with moderate to severe liver or kidney impairment should receive lower doses.
- Rexulti should be taken at the same time each day with or without food.
- It may take several weeks to experience the full therapeutic effect, so patience is important.
Common Side Effects
- Weight gain
- Akathisia (restlessness)
- Sedation
Mechanism of Action
- Partial agonist at dopamine D2 and serotonin 5-HT1A receptors
- Antagonist at serotonin 5-HT2A receptors
- More balanced receptor profile compared to other antipsychotics, potentially offering improved tolerability while still providing effective symptom control for both depression and schizophrenia.
Clinical Evidence
- Brexpiprazole 2-4 mg/day produced statistically significant and clinically meaningful improvements in overall symptomatology and psychosocial functioning compared with placebo in adults with acute exacerbation of schizophrenia 2.
- As maintenance treatment, brexpiprazole 1-4 mg/day significantly delayed the time to relapse compared with placebo in patients who were already stabilized on the drug and was associated with stabilization or continued improvement in patients' symptoms and functioning 2.