The initial PDA launch is scheduled to go live on Friday 5/20. Prescribers are encouraged to certify in the Clozapine REMS Program as soon as possible - but the initial PDA launch will not prevent a dispense from being authorized if a prescriber is not certified. Click on the Important Program Update button for more information.
The initial PDA launch is scheduled to go live on Friday 5/20. Pharmacies should click on the Important Program Update button for more information on how it affects them.
Clozapine is associated with severe neutropenia (absolute neutrophil count (ANC) less than 500/μL). The
requirements to prescribe, dispense, and receive clozapine are incorporated into a single, shared program
called the Clozapine Risk Evaluation and Mitigation Strategy (REMS). A REMS is a strategy to manage known or
potential risks associated with a drug or group of drugs, and is required by the FDA for clozapine to ensure
that the benefits of the drug outweigh the risk of severe neutropenia. The Clozapine REMS Program replaces
the individual clozapine patient registries and the National Non-Rechallenge Master File (NNRMF).
|***Important Program Update (as of 12/16/2016)***||X|