FDA: Major Prescribing Changes for Clozapine

The Food and Drug Administration (FDA) announced changes to prescribing information for clozapine and a new shared risk evaluation and mitigation strategy (REMS) due to continuing safety concerns and current knowledge regarding the risk of severe neutropenia. Clozapine is an atypical antipsychotic agent indicated for the treatment of resistant schizophrenia and to reduce the risk of recurrent suicidal behavior in schizophrenia and schizoaffective disorders.

The requirements to monitor, prescribe, dispense, and receive clozapine are now incorporated into the new shared Clozapine REMS Program, which replaces the six individual clozapine registries. The REMS program includes all clozapine medicines in order to provide a centralized point of access for prescribers and pharmacists in managing the risk of neutropenia. Starting October 12, 2015, clozapine will be available only through the Clozapine REMS Program.

Important changes to the neutropenia monitoring recommendations and treatment algorithm for clozapine include:

• Absolute neutrophil count (ANC) is the only test result accepted in the Clozapine REMS Program to monitor for neutropenia.
• If the patient is an outpatient, the ANC must be reported to the Clozapine REMS Program before clozapine is dispensed.
• If the patient is an inpatient, the ANC must be reported within 7 days of the most recent blood sample.
• Patients with benign ethnic neutropenia (BEN) can now be treated with clozapine.