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 treatment. Clozapine is also used to treat recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.

While clozapine is beneficial for some, there are risks associated with this drug. Specifically, clozapine can decrease the number of neutrophils in the blood. Neutrophils are a type of white blood cell that assists in fighting off infections in the body. In some instances when neutrophils are significantly decreased, severe neutropenia can result leaving a patient prone to infections — particularly those caused by bacteria. Due to this risk, patients taking clozapine need to have their absolute neutrophil count (ANC) monitored on a regular basis. It is this monitoring requirement which serves as the basis for the Clozapine risk evaluation and mitigation strategy (REMS).

The Clozapine REMS Programdisclaimer icon was approved in September 2015. The Clozapine REMS is a shared system program that includes all clozapine medicines. The Food and Drug Administration (FDA) required a shared system REMS for all clozapine products to ensure optimal overall patient monitoring for and management of clozapine-induced severe neutropenia. This system also reduces the burden to the healthcare system by providing a centralized point of access for prescribers and pharmacists in managing this 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.

Due 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 were being extended to help ensure that health care professionals had sufficient time to complete this process and to ensure patient access to clozapine was maintained.

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

The FDA has been working with the 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.

The FDA is continuing to work with clozapine manufacturers to develop a timeline for the full implementation of the shared Clozapine REMS Program, including the pre-dispense authorization (PDA) and prescriber and pharmacy certification requirements. This will be completed in a phased approach beginning in May of 2016.The goal is to have the REMS fully operational by the end of 2016. Please see the Clozapine REMS websitedisclaimer icon for up to date information on the program.

Once the REMS is fully operational, prescribers and pharmacies will need to be certified in the Clozapine REMS Program in order to prescribe and dispense clozapine. 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.

Posted on the FDA website on 26 April 2016