What is clozapine REMS?

An uncommon but serious side effect of clozapine is severe neutropenia, a reduction in a specific type of white blood cell. Severe neutropenia can be fatal if not detected and managed since it makes people vulnerable to infection. In the United States, the Food and Drug Administration (FDA) requires regular blood count monitoring of all patients taking clozapine. The requirements to prescribe, dispense, and receive clozapine are incorporated into a single, shared program called the Clozapine Risk Evaluation and Mitigation Strategy (REMS). The Clozapine REMS Program is a “shared-system,” meaning that it includes all clozapine medications approved by the FDA. The Clozapine REMS Program focuses on patient monitoring for and management of clozapine-induced severe neutropenia, providing a centralized system for prescribers and pharmacists to manage patient risk: https://www.clozapinerems.com or 844-267-8678. Changes were made to the REMS system effective February 28, 2019. Changes include that to receive clozapine, patients must be registered with the REMS, and be part of a system that includes regular monitoring and registry reporting of their Absolute Neutrophil Count. Patients must be enrolled by the prescriber or their designee. Pharmacists must be registered to dispense clozapine. To prescribe clozapine outside a hospital, clinicians must register with the clozapine REMS program, complete a training, and pass a quiz. For more information, see APA’s Clozapine REMS FAQs, Clozapine REMS website, and the SMI Adviser Clinician Q&A presentation.


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