Updated Approaches to Clozapine Monitoring Post-REMS
The US Food and Drug Administration’s (FDA) decision to end the Risk Evaluation and Mitigation Strategy (REMS) program for clozapine doesn’t mean the end of absolute neutrophil count (ANC) monitoring, emphasizes Jonathan Meyer, MD, Psych Congress Consultant. Filmed at the 2025 Psych Congress in San Diego, CA, Dr Meyer offers an updated approach for clinicians navigating clozapine monitoring following the end of REMS. In this insightful discussion, Dr Meyer explores how clinicians can best leverage the flexibility provided by the FDA’s decision while ensuring patient safety and stability throughout clozapine treatment.
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Read the Transcript
Jonathan Meyer, MD: Hi, everyone. This is Dr Jonathan Meyer, voluntary clinical professor of psychiatry at the University of California, San Diego, here in my hometown, enjoying the annual Psych Congress meeting.
Psych Congress Network: In light of the FDA’s decision to end the REMS program, how do you recommend clinicians approach ANC monitoring throughout the initiation and duration of clozapine treatment?
Meyer: The end of REMS doesn't necessarily mean the end of monitoring. The reason REMS was created in part was because there is a recognition that early in the course of clozapine treatment is the period of higher risk for severe neutropenia, and then it tapers off significantly after the first 18 weeks. The package insert now recommends monitoring, and most people think this is in the patient’s best interest. If the patient misses a week of monitoring, you do have the flexibility early on of continuing treatment in a way that we did not before. I think this will benefit everyone.
Where we can really make some modifications is especially when you've been on clozapine for an extended period of time, let's say 3 years or more, where we feel like the risk of severe neutropenia is numerically almost the same as that for other antipsychotics. At that point, you can have a discussion with the patient about whether they want to continue monitoring or not. If they choose to forego it, you simply document in the clinical record that the patient understands there may be a very small risk, but we're going to manage this risk not by a monthly blood test, but by them contacting me if they develop fever or other severe infections, and we can decide together at that point, maybe they should go get a blood count to rule out severe neutropenia.
You have the flexibility, which you didn't before. I think most importantly, you do document your rationale for your approach, especially if there's a period where you decide to forego monitoring after prolonged clozapine exposure.
I'm Jonathan Meyer. I hope you enjoyed this video. Please come back to this site in the future for more clinical updates.
Jonathan Meyer, MD, is a voluntary clinical professor of psychiatry at University of California, San Diego, and a distinguished life fellow of the American Psychiatric Association. Dr Meyer is a graduate of Stanford University and Harvard Medical School, finished his adult psychiatry residency at LA County-USC Medical Center and completed fellowships there in Consultation/Liaison Psychiatry and Psychopharmacology Research. Dr Meyer has teaching duties at UC San Diego and the Balboa Naval Medical Center in San Diego, and is a consultant to the first episode psychosis program at Balboa NMC.
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