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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY May 2017 | Archived Issues

FDA Eliminates Risk Evaluations for ESA Agents

The U.S. Food and Drug Administration (FDA) recently eliminated the risk evaluation and mitigation strategy (REMS) for erythropoiesis-stimulating agents (ESA), which includes Epogen®, Procrit® and Aranesp®.

Established in 2011, the REMS program was designed to ensure that the benefits of ESA therapy to treat anemia due to myelosuppressive chemotherapy outweighed the risks. After further study, the FDA determined in April that the REMS program is no longer necessary.

The elimination of the ESA Apprise Oncology REMS program means:

  • Prescribers are no longer required to be certified before being able to prescribe ESA for patients with anemia due myelosuppressive chemotherapy.
  • Prescribers are no longer required to complete a Patient and Healthcare Provider Acknowledgement Form for each patient before a new ESA course is initiated.
  • Hospitals are no longer required to be certified before being able to dispense ESA for patients with anemia due myelosuppressive chemotherapy.

Prescribers should continue to follow clinical guidelines and hospital protocols when prescribing ESA.

For more information or questions, please contact Drug Use Policy (grouppharmacydup@cshs.org).