FDA Updates Clozapine REMS Program

The FDA has modified the Clozapine Risk Evaluation and Mitigation Strategy (REMS). Starting November 15, 2021, pharmacies that dispense clozapine will now need to obtain a pre-dispense authorization that can be accessed on the Clozapine REMS website (www.clozapineREMS.com) or the Clozapine REMS Contact Center (888-586-0758). They will no longer be able to use the current system, which is called the “switch system,” for verification.

Dispensing pharmacies, as well as wholesalers and distributors, will also need to recertify or re-enroll in the program, which can be done on the website beginning August 16, 2021.

Health care professionals prescribing clozapine will need to re-enroll all patients that are currently prescribed clozapine into the new Clozapine REMS. Physicians can now submit Patient Status Forms monthly, but there is a new form that is being used to document the absolute neutrophil count (ANC) results, monitoring frequency, and appropriateness to continue treatment.

Clozapine, including generics and branded therapies (Clozaril, Fazaclo ODT, Versacloz), is an atypical antipsychotic medicine used to treat schizophrenia symptoms that are not controlled with standard antipsychotic drugs. The drug is also used in patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Clozapine, however, is associated with neutropenia, which can lead to serious and fatal infections.

The Clozapine REMS program was originally approved in September 2015 to monitor patients taking any of the clozapine products. Before this, each manufacturer operated separate monitoring programs.