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 previous 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 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.

Clozapine REMS 2021

Changes to the Clozapine REMS occurred in November 2021. Certain provisions are still under enforcement discretion by the FDA meaning they are not currently mandatory. Most notably, this means that there is not a current mandate to obtain a REMS Dispensing Authorization (RDA). The dispensing quantities for inpatient pharmacies have also been changed to align with the ANC monitoring intervals in the product labeling.

Recent News Concerning the Clozapine REMS

Congressional Leaders Pen Letter On Clozapine REMS to FDA Commissioner

The Schizophrenia and Psychosis Alliance spearheaded an effort with Congressman Brad Sherman’s office to coordinate a letter to FDA Commissioner Robert Califf urging the FDA to reduce clozapine-related barriers by shifting its REMS program to one with an educationally oriented focus for prescribers, pharmacists and front-line clinicians. The letter cites the overwhelming scientific evidence that the burdens imposed by the clozapine REMS program substantially outweigh the risk posed by the medication’s potential side effects. AAPP recently supported a Hill briefing coordinated by the Alliance on this topic with Past-President Deanna Kelly serving as the expert clozapine speaker. Thanks to the Alliance and participating members of Congress responding to concerns expressed by multiple stakeholders and consumers.

Letter to FDA on Clozapine-2023.08.09

Past Communication and Notes Regarding the Clozapine REMS