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U.S. Department of Health and Human Services

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FDA approves a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs)"

On February 16, 2010, the U.S. Food and Drug Administration approved a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs).  The medications included in the program are marketed by Amgen under the names Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and by Centocor Ortho Biotech Products under the name Procrit (epoetin alfa).  FDA required Amgen, the manufacturer of these products, to develop the REMS based on studies demonstrating that use of ESAs can increase the risk of tumor growth and shorten survival in patients with cancer.  Studies conducted in patients with cancer and in patients with renal failure also show that use of ESAs can increase the risk of myocardial infarction, congestive heart failure, stroke and thrombotic events.

As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs.  Additionally, Amgen, in collaboration with Centocor Ortho Biotech Products, was required to develop the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology program for healthcare professionals who prescribe ESAs to patients with cancer.   

Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer.  Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. This program will be implemented within 45 days after FDA approval. 
The ESA APPRISE Oncology program requires that all healthcare professionals who prescribe ESAs in patients with cancer do the following:

  • Complete a training module that covers the use of ESAs for patients with cancer. Completion of the training module is required for enrollment in the ESA APPRISE Oncology program. 
  • Obtain a signed patient/healthcare professional acknowledgement form prior to initiating a new course of ESA therapy.  The acknowledgement form attests that the healthcare professional and patient have discussed the risks with using an ESA.
  • Re-enroll in the ESA APPRISE Oncology program every three years.
  • Healthcare professionals not enrolled in the ESA APPRISE Oncology program will not be able to prescribe ESAs for use in patients with cancer.

As part of the enrollment in the ESA APPRISE Oncology program, healthcare professionals must attest to understanding the following:

  • 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 cancer.
  • Healthcare professionals not enrolled in the ESA APPRISE Oncology program will not be able to prescribe ESAs for use in patients with cancer.
  • To decrease the risks of ESAs, the lowest dose of ESAs should be used to avoid red blood cell transfusion.
  • Aranesp is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for red blood cell transfusions in patients with metastatic, non-myeloid malignancies receiving chemotherapy.
  • Epogen/Procrit is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for red blood cell transfusions in patients with metastatic, non-myeloid malignancies receiving chemotherapy for a minimum of 2 months.
  • ESAs are not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
  • ESA use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being.
  • ESAs should be discontinued following completion of a chemotherapy course of treatment.

 

Additional information on the ESAs, this REMS and the ESA APPRISE Oncology Program is available at  
Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5197lbl.pdf
and http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103234s5199lbl.pdf

 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting Program via an online form at www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid Form 3500 available at www.fda.gov/medwatch, or by telephone (1-800-FDA-1088).