FDA updates clozapine REMS program

The FDA recently reported that most of the issues identified with the Clozapine Risk Evaluation and Mitigation Strategy program have been resolved.

The agency has been working with clozapine manufacturers to address these issues since the program was first implemented in fall 2015.

The Clozapine REMS Program website has been updated to include the following:

Frequently Asked Questions have been updated with new content on the initial Pre-Dispense Authorization (PDA) launch and other updated information;

A PDA fact sheet has been posted in the Program Materials section of the website; and

Recent communications to prescribers and pharmacies about the initial PDA launch have been posted in the Program Materials section.

The FDA will continue to work with clozapine manufacturers to develop a timeline for full implementation of the shared Clozapine REMS program, including PDA and requirements for prescriber and pharmacy certification.

This will be completed in phases beginning in May 2016. The FDA hopes to have the REMS fully operational by the end of 2016.

Once the REMS program is fully implemented, prescribers and pharmacies will need to be certified in the Clozapine REMS program to prescribe and dispense clozapine.

The Clozapine REMS program was approved in September 2015 to ensure optimal patient monitoring for and management of neutropenia associated with clozapine.

The program aims to reduce burden on the health care system by providing a central point of access for prescribers and pharmacies for managing the risk for clozapine-induced neutropenia, regardless of which clozapine product is used.

Prior to program approval, individual clozapine manufacturers had separate patient registries.

For more information:

Visit the Clozapine REMS website at www.clozapinerems.com/.

If prescribers and pharmacies encounter problems when attaining certification, they should contact the Clozapine REMS call center at 844-267-8678.