Clozapine REMS Changes Effective 11/15

Modifications to the risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine approved by FDA 7/20 will take effect 11/15. An agency online FAQ document says the changes are intended to ensure that the drug’s benefits outweigh the risk of severe neutropenia. “The clozapine REMS ensures appropriate patient monitoring for and management of clozapine-induced severe neutropenia and provides a centralized system for prescribers and pharmacists in managing patient risk, regardless of which clozapine product is being used,” the notice says.

Key changes to the REMS listed by FDA are: 

•          pharmacies will no longer be able to use telecommunication verification (switch system) to verify safe use conditions for clozapine, with authorization to dispense clozapine available only through the contact center or REMS Website; and
•          new patient status form to document monitoring for all outpatients that must be submitted monthly.