Adults: Schizophrenia: REXULTI (brexpiprazole) is indicated for treatment of schizophrenia in adults.
In clinical trials, REXULTI was found to significantly improve both positive and negative symptoms.
Adjunctive Treatment of Major Depressive Disorder (MDD): REXULTI is indicated for use as an adjunct to antidepressants for the treatment of major depressive disorder (MDD) in adult patients with an inadequate response to prior antidepressant treatments during the current episode (see Pharmacology: Pharmacodynamics: Clinical Trials: Short-term Adjunctive Treatment in Major Depressive Disorder (MDD) under Actions).
When considering the use of REXULTI as adjunctive treatment in MDD, clinicians must take into account the safety concerns associated with antipsychotic drugs, a class of drugs to which REXULTI belongs. Safety concerns of this class include: weight gain; hyperlipidemia; hyperglycaemia; Tardive Dyskinesia; and Neuroleptic Malignant Syndrome (see Precautions; Adverse Reactions). REXULTI should only be prescribed in patients with MDD by clinicians who are aware of the importance and are experienced in the early detection and management of the safety issues associated with this class of drugs.
The efficacy and safety of REXULTI in the adjunctive treatment of MDD were demonstrated in 6-week, double-blind, placebo-controlled trials in adult patients. Therefore, 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; Recommended dose and dose adjustment: Adjunctive Treatment in Major Depressive Disorder (MDD) under Dosage & Administration).
Clinical trials evaluating REXULTI in MDD did not include REXULTI monotherapy treatment arms. It is, therefore, not known whether efficacy in adjunct treatment is due to REXULTI alone or from combined treatment with an antidepressant.
Geriatrics (> 65 years of age): 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). The safety and efficacy of REXULTI have not been systematically evaluated in patients 65 years of age or older. Caution should be used when treating geriatric patients (see Pharmacology: Pharmacokinetics: Special Populations and Conditions: Geriatrics under Actions; Use in the Elderly: Geriatrics (> 65 years of age) under Precautions).
Pediatrics (< 18 years of age): The safety and efficacy of REXULTI have not been established in patients less than 18 years of age. REXULTI is not indicated in pediatric patients and its use is not recommended in this population (see Use in Children under Precautions).