Clozapine REMS Delayed

PUBLISHED: Dec 20, 2016

Although the US Food and Drug Administration (FDA) announced in May 2016 that the full REMS program launch would occur in December 2016, recent technical and logistical challenges necessitate that the FDA postpone the launch.

The Clozapine Product Manufacturers’ Group and the FDA are continuing to work to ensure that patients relying on clozapine have continued access to this medication and appropriate management of associated risks. The FDA is planning a phased approach to implementing the Clozapine REMS Program in order to carefully balance patient access and ensuring the safe use of clozapine during the transition to a fully implemented Clozapine REMS Program.

Prescribers and pharmacies that have not certified in the Clozapine REMS Program are encouraged to use this additional time to certify in the program before the full launch, which includes a fully implemented predispense authorization (PDA) for pharmacies.

In addition, prescribers should submit absolute neutrophil count (ANC) results to the Clozapine REMS Program according to the patients monitoring frequency (i.e. within 7, 15, or 31 days) to ensure the ANC is current.

If prescribers and/or pharmacies are not certified in the Clozapine REMS Program and the ANC in the Clozapine REMS Program is not current after the full launch, this will impact the pharmacy’s ability to dispense clozapine, negatively affecting patient care.

Updated information will be sent to prescribers and pharmacies once an implementation date has been confirmed.

Follow the link below for additional information.

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