Modifications to the national Clozapine REMS (Risk Evaluation and Mitigation Strategy) Program go into effect on November 15, 2021, that will affect program users.
The Clozapine REMS is a safety program required by the Food and Drug Administration (FDA) to manage the risk of severe neutropenia associated with clozapine treatment. Neutropenia occurs when a person has too few neutrophils, a type of white blood cell that helps fight infections, especially those caused by bacteria.
The Clozapine Product Manufacturers’ Group (CPMG) and FDA continue to work to ensure that patients relying on clozapine have continued access to this medication and appropriate management of associated risks. New requirements include:
- Clozapine prescribers must re-certify in the newly updated Clozapine REMS Program. Anyone who fails to re-certify is prohibited from legally prescribing clozapine from November 15 forward.
- Prescribers must re-enroll patients in the updated Clozapine REMS Program. Patients who are not re-enrolled by November 15 will no longer be able to receive clozapine.
- A new patient status form, documenting absolute neutrophil count (ANC) monitoring, must be submitted by prescribers to the Clozapine REMS Program.
Because failure to comply with these new rules may impact care for residents, it is important that providers ensure that Clozapine prescribers act as soon as possible. Facility providers can request lists of residents on Clozapine from their long-term care pharmacies.
More information can be found on the Clozapine REMS Program website at or by calling the Clozapine REMS Program Contact Center at 888-586-0758.