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FDA Approves Rexulti for Schizophrenia

Drug also gets go-ahead as add-on for MDD

Indications: Rexulti (brexpiprazole) is an atypical antipsychotic indicated for treatment of schizophrenia and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder.

Dosing: The recommended starting dosage for treatment of schizophrenia is 1 mg once daily on days 1 to 4, taken orally with or without food. The recommended target dosage is 2 mg to 4 mg once daily. The recommended starting dosage 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 target dosage of 2 mg once daily.

Pharmacokinetics: After single dose administration of Rexulti tablets, the peak plasma brexpiprazole concentrations occurred within 4 hours after administration; and the absolute oral bioavailability was 95%. Brexpiprazole steady-state concentrations were attained within 10-12 days of dosing. Can be administered with or without food.

Side Effects/Risks: Most serious adverse reaction is increased mortality in elderly patients with dementia-related psychosis; increased incidence of cerebrovascular adverse reactions. Suicidal thoughts and behaviors may occur.

Source: Highlights of Prescribing Information: Rexulti (brexpiprazole). FDA website.

Revised July 2015. Accessed July 13, 2015.