Rexulti Approved to Treat Schizophrenia in Pediatric Patients

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December 27, 2021 – Rexulti® (brexpiprazole – Otsuka Pharmaceutical) is now approved to treat schizophrenia in patients who are at least 13 years old. Previously, FDA approval for this indication was limited to adult patients.

  • First FDA approved in 2015, Rexulti is also indicated as an adjunctive therapy to antidepressants for treatment of major depressive disorder in adults.
  • Recommended dosing for schizophrenia is as follows:
    • Adult Patients: 1mg per day (taken by mouth) for the first four days, titrated up to 2mg per day during Days 5-7 of treatment, with the option to titrate to a maximum daily dose of 4mg starting on Day 8, depending on response to treatment.
    • Pediatric Patients: 0.5mg once daily (taken by mouth) for the first four days, titrated up to 1mg per day during Days 5-7 of treatment, then to 2mg per day on Day 8 depending on clinical response. If needed, weekly dose increases can then be used to titrate up to a maximum dose of 4mg per day.