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Adjunctive Treatment of Major Depressive Disorder: The recommended starting dose for REXULTI as adjunctive treatment is 0.5 mg or 1 mg once daily. Dose titration to 1 mg/day and up to the target dose of 2 mg/day should occur at intervals of up to 1 week based on the patient's clinical response and tolerability. Doses up to 3 mg/day have been studied in clinical trials. The benefit of the 3 mg dose has not been clearly established. Periodically reassess to determine the continued need and appropriate dose for treatment.
The long-term efficacy of REXULTI as adjunctive treatment in MDD has not been established.
Schizophrenia: The recommended starting dose for REXULTI in the treatment of patients with schizophrenia is 1 mg once daily on days 1 to 4. The recommended target dose range 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.
Maintenance treatment: The recommended maintenance dose range is 2 mg/day to 4 mg/day. Periodically reassess to determine the continued need for maintenance treatment.
Treatment of Agitation Associated with Alzheimer's Dementia: The recommended starting dosage for REXULTI for the treatment of AAD is 0.5 mg taken orally once daily on Days 1 to 7. The dosage should be titrated on Days 8 through 14 to 1 mg, and on Day 15 to 2 mg.
The recommended target dose range is 2 mg once daily. After at least 14 days at 2 mg once daily, the dose can be increased to the maximum recommended daily dose of 3 mg, if clinically warranted.
Dosing Precautions: Dosing Adjustment 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 or AAD, and 3 mg once daily for patients with schizophrenia.
Dosing Adjustment 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 or AAD and 3 mg once daily for patients with schizophrenia. (See Table 5.)
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