It was announced today that the FDA has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs) in patients with cancer.
Elements of the REMS include:
- A Medication Guide must be provided to all patients receiving ESAs
- Providers are required to train and enroll in the ESA APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology Program
- Providers are required to document that a discussion about the risks of ESAs took place with each patient prior to the initiation of each new course of ESA therapy
The ESA APPRISE Oncology Program will launch on March 24, 2010. Direct patient registration or approval prior to ESA administration is not required through this program. The manufacturers will distribute a Dear Healthcare Provider letter within 45 days which will provide additional details on the program.
Edited to add: information available directly from FDA here.
Edited to add: visit the APPRISE website directly at www.esa-apprise.com