Clozapine in Practice

Clozapine REMS Eliminated Effective 2/24/25

CPMG Provides Estimated Timeline for Clozapine Prescribing Updates and Sunsetting Timeline for newclozapinerems.com Website

An Important Message for Pharmacies

Beginning February 24, 2025, FDA does not expect prescribers, pharmacies, and patients to participate in the risk evaluation and mitigation strategies (REMS) program for clozapine or to report results of absolute neutrophil count (ANC) blood tests before pharmacies dispense clozapine. FDA still recommends that prescribers monitor patients’ ANC according to the monitoring frequencies described in the prescribing information. Information about severe neutropenia will remain in the prescribing information for all clozapine medicines, including in the existing Boxed Warnings. 

Summary of the November 19, 2024 Meeting of the Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee on Clozapine REMS

A joint FDA advisory committee overwhelming voted to eliminate the risk evaluation and mitigation strategy (REMS) program designed around the risk for severe neutropenia associated with clozapine, a drug used to treat schizophrenia and schizoaffective disorder. All but one of the 15 voting panel members said the current requirements for prescribers to document absolute neutrophil count (ANC) results and for pharmacies to verify results are not necessary to ensure safe use of the atypical antipsychotic. 
 

Clozapine in Practice

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3/31/25: Updates to this toolkit are in progress to reflect REMS elimination.

Clozapine is the medication of choice for those with treatment-resistant schizophrenia. Clozapine is also FDA approved for the reduction in suicidal behavior in schizophrenia or schizoaffective disorder and effective for treatment-resistant mood disorders. Despite the clinical benefits of clozapine, hesitancy to prescribe the medication is not uncommon based on perceived dangers and rigorous monitoring parameters. One method to overcome barriers of clozapine use includes ensuring adequate education about the medication.

This toolkit contains important clozapine-related drug information such as:

  • Considerations when starting clozapine 
  • Baseline screening parameters  
  • Ongoing monitoring 
  • Drug interactions 
  • Potential adverse reactions with prevention and management strategies    
  • An introduction to clozapine-augmentation strategies 

Authored by AAPP members Jonathan G. Leung, PharmD, BCPS, BCPP, Greg Deardorff, PharmD, BCPP, Megan Trout, PharmD, and Robin Hieber, PharmD, BCPP, this toolkit is intended to highlight both the evidence base available as well as strategies of clinical decision making used by expert clinicians.