Information on Clozapine

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 Programdisclaimer icon 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 Programdisclaimer icon 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.

Latest Update

January 2, 2018----Pharmacies that are currently certified in the Clozapine REMS Program disclaimer icon agreed to renew certification every two years. To maintain certification to order and dispense clozapine, authorized representatives are encouraged to verify their pharmacy certification is current to avoid deactivation from the Clozapine REMS Program. The Clozapine Product Manufacturers’ Group (CPMG) has recently communicated with pharmacies regarding recertification requirements under the program. The deactivation process for pharmacies choosing not to recertify started December 15, 2017. Questions regarding this process should be directed to the Clozapine REMS Call Center at 844-267-8678.    
Prescribers and pharmacies that have not certified in the Clozapine REMS Program are encouraged to certify in the program before the full launch, which includes a fully implemented predispense authorization (PDA) for pharmacies. Prescribers and pharmacies should continue to adhere to the current Clozapine REMS Program requirements. Please see the CDER Statements for previous updates.

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 Websitedisclaimer icon for up-to-date and detailed information about the program.

Related Resources

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

Clozapine REMS websitedisclaimer icon

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 druginfo@fda.hhs.gov, 1-855-543-3784 or 301-796-3400.

Page Last Updated: 01/02/2018
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