Recommended dose and dose adjustment: See Table 3.
Click on icon to see table/diagram/image
Schizophrenia: The recommended starting dosage for REXULTI is 1 mg once daily on Days 1 to 4, taken orally with or without food.
The recommended target REXULTI dosage is 2 mg to 4 mg once daily. In short-term fixed-dose clinical trials, the dose was titrated to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8. The maximum recommended daily dosage is 4 mg. Periodically reassess to determine the continued need and appropriate dosage for treatment.
Patients should be treated with the lowest effective dose that provides optimal clinical response and tolerability.
Adjunctive Treatment in Major Depressive Disorder (MDD): The dose range of 1 to 3 mg/day was evaluated as adjunctive treatment in clinical trials. No additional benefit was demonstrated at doses greater than 2 mg/day (see Pharmacology: Pharmacodynamics: Clinical Trials: Short-term Adjunctive Treatment in Major Depressive Disorder (MDD) under Actions). Periodically reassess to determine the continued need and appropriate dose for treatment.
The required length of adjunctive treatment with REXULTI is not known. When prescribed as an adjunct to antidepressants in the treatment of MDD, REXULTI should be used for the shortest period of time that is clinically indicated (see Pharmacology: Pharmacodynamics: Clinical Trials: Short-term Adjunctive Treatment in Major Depressive Disorder (MDD) under Actions).
The recommended starting dose for REXULTI as adjunctive treatment is 0.5 mg or 1 mg once daily, taken orally with or without food.
Titrate to 1 mg once daily, then up to the recommended 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 dose is 2 mg once daily.
Dosing Considerations: Hepatic Impairment: For patients with moderate to severe hepatic impairment (Child-Pugh score ≥7), the maximum recommended dosage is 3 mg once daily for patients with schizophrenia and 1.25 mg once daily for patients with MDD.
Renal Impairment: For patients with moderate, severe or end-stage renal impairment (creatinine clearance CLcr<60 mL/minute), the maximum recommended dosage is 3 mg once daily for patients with schizophrenia and 1.25 mg once daily for patients with MDD.
CYP isozymes: 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 4). If the co-administered drug is discontinued, adjust the REXULTI dosage to its original level. If the co-administered CYP3A4 inducer is discontinued, reduce the REXULTI dosage to the original level over 1 to 2 weeks. (See Table 4.)
Click on icon to see table/diagram/image
Geriatrics: The safety and efficacy of REXULTI in patients 65 years of age or older have not been established. Caution should be used when treating geriatric patients (see Use in the Elderly: Geriatrics (> 65 years of age) under Precautions). REXULTI is not indicated in elderly patients with dementia (see Increased Mortality in Elderly Patients with Dementia under Warnings; Use in the Elderly: Use in Elderly Patients with Dementia under Precautions).
Missed Dose: If a dose is missed then it should be taken as soon as possible unless it is close to the next dose. Two doses should not be taken.
Administration: REXULTI may be given once daily, with or without food.
Switching from Other Antipsychotics: There are no systematically collected data to specifically address switching patients with schizophrenia or MDD from other antipsychotics to REXULTI or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia or MDD, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.