On July 29, 2021, FDA approved a modification to the Clozapine Risk Evaluation and Mitigation Strategy (REMS).
Beginning November 15, 2021 new requirements will go into effect. Key changes include:
- Pharmacies will no longer be able to use the telecommunication verification (the switch system) to verify safe use conditions for clozapine. The authorization to dispense clozapine can be obtained either through the contact center or online via the REMS website.
- New Patient Status Form to document monitoring for all outpatients. This form must be submitted monthly.
- Patient monitoring must still continue per the Prescribing Information.
- All prescribers and pharmacies must be re-certified by November 15, 2021 or they will no longer be able to prescribe/dispense clozapine.
- Prescribers must re-enroll their patients who will continue clozapine by November 15, 2021. Patients who ae not re-enrolled by that date will no longer be able to receive clozapine. Re-certification and re-enrollment can begin on August 16, 2021.
- To re-certify and re-enroll in the Clozapine REMS please see the Important Program Update at www.clozapineREMS.com.
Information on Clozapine
Clozapine (marketed as Clozaril, Fazaclo ODT, Versacloz and generics) is an antipsychotic medicine used to treat schizophrenia in patients whose symptoms are not controlled with standard antipsychotic drugs. Clozapine is also used in patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.
While clozapine is beneficial for some patients, there are risks associated with this drug. Specifically, clozapine can decrease the number of neutrophils, a type of white blood cell, that function in the body to fight off infections. When neutrophils are significantly decreased, severe neutropenia may result and the body may become prone to infections. For this reason, patients taking clozapine need to have their absolute neutrophil count (ANC) monitored on a regular basis. This monitoring requirement serves as the basis for the Clozapine Risk Evaluation and Mitigation Strategy (REMS).
Clozapine REMS Program
The Clozapine REMS Programwas approved in September 2015 and is a “shared-system” program, meaning that it includes all clozapine medicines approved by the Food and Drug Administration (FDA). The Clozapine REMS Program ensures optimal patient monitoring for and management of clozapine-induced severe neutropenia, providing a centralized system for prescribers and pharmacists in managing patient risk, regardless of which clozapine product is being used. Prior to the approval of the Clozapine REMS Program, individual clozapine manufacturers operated separate patient registries.
In response to implementation challenges identified following the approval of the Clozapine REMS Program, the FDA announced, in November 2015, that the deadlines for certification of prescribers and pharmacies would be extended to help ensure that health care professionals had sufficient time to complete certification and to ensure patient access to clozapine was maintained.
We believe that most of the issues identified to date have been resolved. If prescribers and pharmacies experience problems while attempting to become certified, they should contact the Clozapine REMS Call Center at 844-267-8678.
In an effort to provide timely clozapine information to prescribers, pharmacies, patients, and distributors, the FDA will post any related updates on clozapine and the Clozapine REMS Program on this page.
- Frequently Asked Questions | Clozapine REMS Modification
- CDER Statements: The Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program Modification will go live on February 28, 2019, 1/16/19, 12/16/16, 11/19/15, 11/13/15, and 10/20/15.
- FDA Drug Safety Communication: FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines, 9/15/15
- Clozapine REMS website
- Clozapine REMS information on the FDA website
If you have questions or concerns about the Clozapine REMS Program or its website please contact FDA at email@example.com, 1-855-543-3784 or 301-796-3400.