The Food and Drug Administration (FDA) has approved a modification to the Clozapine REMS program that will go into effect on November 15, 2021 to ensure that patients have continued access to clozapine and that associated risks are appropriately managed.
Clozapine is an atypical antipsychotic indicated for treatment-resistant schizophrenia and for reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. The treatment is only available through the restricted program known as the Clozapine REMS program due to the risk of severe neutropenia. Patients who receive clozapine must be enrolled in the program and comply with the absolute neutrophil count (ANC) testing and monitoring requirements.
According to the Agency, the Clozapine REMS program will include the following important modifications:
- Prescribers and pharmacies must be re-certified in the Clozapine REMS program by November 15, 2021 to continue to prescribe or dispense clozapine.
- Prescribers must re-enroll their patients who will continue receiving clozapine by November 15, 2021.
- The process for re-certification and re-enrollment can begin on August 16, 2021.
- Pharmacies will have to obtain authorization to dispense clozapine either through the REMS Contact Center or online via the REMS website. The telecommunication verification (also known as the switch system) may no longer be used by pharmacies to verify safe use conditions.
- For all outpatients, there will be a new Patient Status Form to document ANC monitoring. The form must be submitted monthly and should be used to interrupt, discontinue, or resume treatment; designate the patient as a benign ethnic neutropenia (BEN) patient; create a treatment rationale when the patient’s ANC level is below 1000/µL for a general population patient or less than 500/µL for a BEN patient; or designate the patient as a hospice patient.
For more information, please call the Clozapine REMS Contact Center at (844) 267-8678 or visit clozapinerems.com.
Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirements will change on November 15, 2021. News release. US Food and Drug Administration. July 29, 2021. Accessed July 30, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/clozapine-risk-evaluation-and-mitigation-strategy-rems-requirements-will-change-november-15-2021.