FDA Modifies REMS Program for Clozapine

Regulatory NewsRegulatory News | 17 January 2019 |  By 

The US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.
Clozapine, which is marketed as Clozaril, Fazaclo ODT and Versacloz, is an antipsychotic drug first developed in the late 1950s and was first approved by FDA in 1989. Clozapine is indicated for the treatment of schizophrenia in patients whose symptoms are not adequately controlled using other antipsychotic drugs and to treat patients with recurrent suicidal behavior associated with schizophrenia.
While clozapine can be effective in treating some patients, FDA says that the drug carries serious risks.
"Specifically, clozapine can decrease the number of neutrophils, a type of while blood cell, that function in the body to fight off infections," FDA writes.
FDA first required a REMS for clozapine in September 2015. The REMS applies to all clozapine medicines on the market and requires patient monitoring via a centralized system to monitor and manage clozapine-induced neutropenia.
Prior to 2015, individual manufacturers operated their own clozapine patient registries.
REMS Modification
Under the latest modification to the clozapine REMS, FDA is making changes to who must be certified to participate in the program and restricting pharmacies from enrolling patients in the clozapine registry.
As of 28 February 2019, FDA says that prescribers and pharmacies must be certified under the REMS or they will not be able to prescribe or dispense clozapine.
Inpatient prescribers, on the other hand, do not need to be certified to prescribe clozapine to patients who are already enrolled in the registry.
FDA is also allowing pharmacies to dispense clozapine to patients who do not have a current absolute neutrophil count (ANC) to ensure treatment is not disrupted.
Additionally, FDA says that pharmacies will no longer be allowed to enroll patients in the REMS program as enrollment must be completed by their prescriber once the REMS modifications take effect.
Physicians that need to be certified for the REMS are instructed to visit www.clozapinerems.com and once certified ensure that any prescriber designees are also enrolled.
Outpatient prescribers are also instructed to obtain an ANC for their patients to submit to the REMS program before the drug is dispensed. For patients whose last ANC shows moderate to severe neutropenia, FDA says that clozapine can not be dispensed unless their prescriber has documented that the benefits of clozapine outweigh the risks of neutropenia.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy