Information on How the New ESA REMS Program Will Affect MDS Patients

2010-03-11

On March 24, the Food and Drug Administration (FDA) will require that all drugs categorized as erythropoiesis-stimulating agents (ESAs) be prescribed and used under a risk management program, known as a risk evaluation and mitigation strategy (REMS), to ensure the safe use of these drugs.

Since the FDA announced the REMS program, ASH has heard from several hematologists who raised questions and concerns about how the program will apply to their patients with myelodysplastic syndrome (MDS). The FDA has clarified that patients with MDS who are prescribed ESAs are not included in the APPRISE program. This is because ESAs are not indicated for the treatment of anemia due to MDS and the APPRISE program does not address off-label uses. The APPRISE Program is designed for health-care professionals prescribing ESAs for approved uses in the course of treating patients with cancer. Please note, however, as part of the REMS program, a Medication Guide is required to be distributed to all patients whenever an ESA is dispensed, either for an approved indication or for an unapproved indication under the practice of medicine. The Medication Guide explains the risks and benefits of ESAs.

ASH continues to seek further clarification from FDA about how the REMS will apply to MDS patients, including clarification about the frequency required to provide Medication Guides. If you have any specific questions about how the REMS will apply to your MDS patients, please contact ASH Government Affairs Manager Stephanie Kart.

Amgen plans to distribute additional information about the REMS to health-care professionals on March 24, 2010. In the meantime, health-care professionals should begin to receive mailings from Amgen on how to register, enroll in the program, and obtain copies of the Medication Guide.

If you have any questions about the ESA APPRISE Oncology Program or the Medication Guide:

  • Visit the FDA Web site
  • Contact your local Amgen or Centocor Ortho Biotech Products Field Representative
  • Call the ESA APPRISE Oncology Program Call Center at 866-284-8089
  • Contact ASH at grassroots@hematology.org 

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