Drug Information Update- New Website for Clozapine

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

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 Program 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 to the link below.

For more information, please visit: Clozapine.