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UZEDY (risperidone extended-release injectable suspension) is approved for once-monthly or once-every-two-months subcutaneous dosing in adults with schizophrenia. The 2-month dosing interval (every 8 weeks) uses higher strengths—100 mg or 125 mg—to maintain therapeutic risperidone levels over that period.[1][2]
It delivers steady risperidone release via a subcutaneous depot, with peak plasma levels around day 7-10 and sustained exposure through week 8. Clinical trials showed equivalent efficacy and safety to monthly dosing, with no significant loss in schizophrenia symptom control.[2][3]
Administer as soon as possible, then resume every 8 weeks. If delayed over 8 weeks, restart with monthly dosing to rebuild levels. Plasma monitoring may guide adjustments.[2]
Common issues like weight gain, somnolence, and injection-site reactions occur similarly to monthly use. Long-acting nature means effects linger if issues arise—prolactin elevation and EPS risks persist.[2][3]
Teva Pharmaceuticals and MedinCell developed it. FDA approved in April 2023; 2-month dosing added December 2023.[1][4] [1]: UZEDY Prescribing Information (Teva) [2]: FDA Label for UZEDY [3]: Phase 3 RISE Study (NPJ Schizophrenia) [4]: Teva Press Release (Dec 2023)
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