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 Program was 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.
The FDA will continue to work with clozapine manufacturers to address the issues identified when the Clozapine REMS Program was initially implemented. We believe that most of the issues 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.
Although the FDA announced in May 2016 that the full REMS program launch would occur in December 2016, recent technical and logistical challenges necessitate that we postpone the launch. The Clozapine Product Manufacturers’ Group and the FDA are continuing to work to ensure that patients relying on clozapine have continued access to this medication and appropriate management of associated risks. We are planning a phased approach to implementing the Clozapine REMS Program in order to carefully balance patient access and ensuring the safe use of clozapine during the transition to a fully implemented Clozapine REMS Program.
Please see the updated CDER Statement for more details.
We encourage certification prior to the new deadline, if prescribers and pharmacies have not already done so.
This website will be updated once new deadlines for certification have been established.
Please see the Clozapine REMS Website for up-to-date and detailed information about the program.
CDER Statements: FDA working with manufacturers to resolve challenges with the Clozapine REMS Program, 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
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.