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FDA Removes Clozapine REMS Requirement to Report Patients’ Absolute Neutrophil Count
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Key Takeaways
- The FDA will eliminate the REMS program for clozapine, reducing healthcare system burdens and improving drug access.
- Clozapine's risk of severe neutropenia remains, but the REMS program is deemed unnecessary to ensure benefits outweigh risks.
The move is expected to expand clozapine access for patients with schizophrenia.
The FDA will no longer require pharmacies, prescribers, and patients to participate in the Risk Evaluation and Mitigation Strategy (REMS) program for clozapine (Clozaril; HLS Therapeutics USA, Inc.), an antipsychotic medicine indicated for the treatment of schizophrenia in patients whose symptoms are not controlled with standard antipsychotic drugs. REMS, a shared program that was initially approved in September 2015, served as a measure for health care professionals to report results of absolute neutrophil count (ANC) blood tests prior to dispensing clozapine.1,2
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Although clozapine is beneficial for patients, according to the FDA, there are risks associated with this drug. Clozapine may decrease the number of neutrophils, a type of white blood cell, that function in the body to fight off infections.1 Severe neutropenia is associated with an increased risk of serious and potentially fatal infections and occurs in a small percentage of patients who take clozapine.2 For this reason, patients taking clozapine were required to have their ANC monitored on a regular basis.1
Previously, the REMS program required patients to undergo weekly blood draws in the first 6 months of treatment, and following completion of the 6-month duration, patients then graduated to blood draws every 2 weeks until month 12 and monthly draws thereafter. Prescribers were instructed to document a patient's ANC by fax or the web-based REMS system, which then authorized the REMS-registered pharmacy to dispense clozapine to the patient. Prescribers and pharmacy staff were also required to complete training to become certified to prescribe and dispense clozapine, according to a MedPage Today news release.2
Furthermore, the Clozapine REMS Program helped ensure optimal patient monitoring and the management of clozapine-induced severe neutropenia by providing a centralized system for prescribers and pharmacists in managing patient risk, regardless of the clozapine product being used. Prior to the approval of the program, individual clozapine manufacturers had separate patient registries they managed.1
This decision follows advice from a nearly unanimous joint FDA advisory committee, which weighed the program as no longer necessary. Experts believe that eliminating the REMS is expected to decrease the burden on the health care delivery system, therefore improving access to clozapine. This treatment is indicated for patients with recurrent suicidal behavior that is associated with schizophrenia or schizoaffective disorder and is the only drug currently indicated for treatment-resistant schizophrenia.1,2
The FDA explained that, although severe neutropenia with clozapine still exists, the REMS program for clozapine is no longer necessary to ensure the benefits of the medicine outweigh that risk. The agency notified manufacturers of clozapine that the REMS program must be eliminated. In addition, they instructed these manufacturers to formally submit a modification to eliminate the Clozapine REMS and to update their prescribing information, including removing mandatory reporting of ANC blood tests to the REMS program. Despite the removal of the program, health care professionals are still encouraged to monitor patients ANC labels as outlined in the label’s prescribing information.1
The FDA has stated that in the coming months, the agency will work with the clozapine manufacturers to update the prescribing information and eliminate the clozapine REMS.1 The risk for severe neutropenia—which is defined as an ANC count less than 500 cells/uL—still exists, and it will remain listed within the boxed warning on all clozapine products.1,2
