Welcome to the ESA APPRISE Oncology Program

What is the ESA APPRISE Oncology Program?

Erythropoiesis Stimulating Agents (ESAs) include Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa), and Procrit® (epoetin alfa). The Food and Drug Administration (FDA) determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the decision to initiate ESA treatment for a patient with cancer begins with a discussion between the patient and healthcare provider (HCP) about the benefits and risks associated with ESA therapy.*

Amgen and Janssen Products, LP have implemented the ESA APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology Program as part of a REMS designed for HCPs treating patients with an ESA for their cancer.

What are the risks addressed through the ESA APPRISE Oncology Program?

  • Increased risk of death and/or increased risk of tumor progression or recurrence in patients with cancer.
    • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.

Key Program Requirements

Healthcare Providers Hospitals
1. Complete Training 1a. Select a Hospital Designee
1b. Hospital Designee Completes Training
2. Enroll in the ESA APPRISE Oncology Program 2. Enroll in the ESA APPRISE Oncology Program
3. Counsel and Document
  • Counsel each patient on the risks of ESAs prior to each new course of ESA therapy.
  • Document that the risk:benefit discussion with each patient has occurred by completing the Acknowledgment Form and providing each patient a copy of the signed form.
3. Implement
  • Hospital Designee to establish or oversee the establishment of a system, order sets, protocols, or other measures designed to ensure that the hospital is in compliance with the Program.

The ESA APPRISE Oncology Program training and enrollment takes you step-by-step through the required training and enrollment process.

Failure to comply with the ESA APPRISE Oncology Program requirements will result in suspension of your access to ESAs

Questions about the ESA APPRISE Oncology Program?

If you need more information about the ESA APPRISE Oncology Program:

  • Call the ESA APPRISE Oncology Program Call Center at 1-866-284-8089, or
  • Contact your local Amgen or Janssen Products, LP Field Representative

*Additional information on REMS may be found at www.FDA.gov

Aranesp® and Epogen®/Procrit® are different drugs with distinct dosing schedules.

This document has been required by the US Food and Drug Administration as part of a Risk Evaluation and Mitigation Strategy (REMS) for Aranesp®, Epogen®, and Procrit®.


This program is intended for residents of the United States only.
© 2013 Amgen and Janssen Products, LP