Full Launch of Clozapine REMS Program Postponed

Clozapine Product Manufacturers' Group and the FDA are working to ensure patients have access to the drug
Clozapine Product Manufacturers' Group and the FDA are working to ensure patients have access to the drug

The Food and Drug Administration (FDA) has announced that the full launch for the Clozapine Risk Evaluation and Mitigation Strategy (REMS) program will be postponed due to recent technical and logistical challenges. The launch was initially planned for December 2016.

The Clozapine Product Manufacturers' Group and the FDA are working together to ensure that patients have continued access to the drug and appropriate management of associated risks. They are planning a phased approach to implementing the Clozapine REMS Program to ensure safe medication use during the transition to a fully implemented REMS Program.  

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Non-certified prescribers and pharmacies in the Clozapine REMS Program are encouraged to certify in the program prior to the full launch, which includes a fully implemented predispense authorization (PDA) for pharmacies. Prescribers are also to submit absolute neutrophil count (ANC) results to the Clozapine REMS Program according to the patient's monitoring frequency (eg, within 7, 15 or 31 days) to ensure that the ANC is current. 

If pharmacies and prescribers are not certified in the REMS program, and if the ANC is not current after the full launch, this will affect the pharmacy's ability to dispense clozapine. 

During this transition period, however, the absence of prescriber and pharmacy certification or a current ANC will not preclude a patient being dispensed clozapine. 

When an implementation date has been confirmed, updated information will be communicated to prescribers and pharmacies. 

For more information call (844) 267-8678 or visit FDA.gov.