The Clozapine Risk Evaluation and Mitigation Strategy (REMS) is a crucial safety program mandated by the U.S. Food and Drug Administration (FDA). Its primary goal is to monitor and mitigate the risk of severe neutropenia—a condition characterized by a dangerously low level of neutrophils (a type of white blood cell)—that can occur with clozapine treatment. Severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/µL, poses a significant threat as it can lead to severe and potentially fatal infections.
To ensure safe administration, patients must be enrolled in the Clozapine REMS program by a certified healthcare provider. This certification ensures that the provider has received the necessary training and understands the protocols required to manage and monitor the risks associated with clozapine treatment.
