Clozapine REMS 2021

Changes to the Clozapine REMS have been announced and are to be implemented on 11/15/2021. CPNP recently released recommendations expressing concerns to the FDA and Clozapine Products Manufacturer Group (CPMG) about the implementation date and various elements of the new Clozapine REMS system. CPNP staff and Past Presidents Megan Ehret will be representing psychiatric pharmacy and the patients we serve on an FDA listening session on October 20. Per our letter in coalition with our partners, CPNP is urging a delay in the implementation date and suggesting several changes to the REMS system and will report outcomes to the CPNP membership as we learn about them after the FDA listening session.

Please visit our resources on the new Clozapine REMS. The Clozapine FAQ document will continue to be updated as additional information and changes are announced.

Clozapine in Practice

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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.

As an update to the 2011 toolkit in the MHC, this version 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 CPNP 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.