Managing existing patients:
- All patients registered in any of the existing clozapine registries within the last three years and all patients listed in the NNRMF will be automatically transferred into the Clozapine REMS Program.
- Starting October 12, 2015, prescribers will no longer be able to enroll or manage patients through the other clozapine patient registries. All patient management activities will be handled through the Clozapine REMS Program.
Managing new patients:
- Prescribers must be certified in the Clozapine REMS Programdisclaimer icon in order to enroll new patients.
- Generally, to enroll a new patient prescribers must provide the patient or caregiver with What you Need to Know about Clozapine: A Guide for Patients and Caregivers, inform the patient or caregiver about the risk of severe neutropenia associated with clozapine and about the Clozapine REMS Program requirements, and complete and submit Patient Enrollment Form.
- Prescribers can enroll patients through the Clozapine REMS Program website at clozapinerems.com, or by faxing the completed Patient Enrollment Form to (844) 404-8876.
Prescribers may designate other health care professionals or office staff to enroll patients and enter ANC results on their behalf.
For more information visit FDA.gov.