Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 9/15/15

Clozapine REMS

Goal of the Clozapine REMS Program

The goal of the Clozapine REMS Program is to mitigate the risk of severe neutropenia associated with the use of clozapine by:

A. Educating prescribers and pharmacists about the risk of severe neutropenia and appropriate monitoring requirements

B. Informing patients about the risk of severe neutropenia and appropriate monitoring requirements

C. Ensuring compliance with the monitoring schedule for absolute neutrophil count (ANC) prior to dispensing clozapine

D. Ensuring the prescriber documents a risk-benefit assessment when ANC falls below the acceptable range as described in the Prescribing Information

E. Establishing long-term safety and safe use of clozapine by enrolling all patients who receive clozapine in the registry

REMS Elements

• Elements to Assure Safe Use

• Implementation System