FDA Approves Risk Management Plan for ESAs

Cancer patients will learn more from their doctors about the possible risks and benefits of erythropoiesis-stimulating agents (ESAs) to manage anemia during chemotherapy under a new program just approved by the FDA.

ESAs can be given to chemotherapy patients to reduce the need for blood transfusions.  However, there can be problems with ESAs including causing some tumors to grow faster or some patients to die sooner.  They can also increase risk for blood clots, heart failure, heart attack or stroke.

ESAs, including Procrit®, Epogen®, and Aranesp®, are now covered by a REMS or Risk Evaluation and Mitigation Strategy which requires that patient receive a Medication Guide from their health care providers that tells them how to safely use an ESA drug.

In addition, health care providers who use ESAs with their patients must be be actively enrolled in  the APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) Oncology program and receive training in their safe use. 

ESAs are forms of the human protein erythropoietin, which stimulates bone marrow to make red blood cells.   Chemotherapy can cause anemia, which is the loss of these cells.  If red cells counts fall too low, a blood transfusion may be necessary.

Because of the potential risks of ESA treatment, the FDA required Amgen, Inc., which manufacture Aranesp, Epogen, and Procrit, to develop a Medication Guide and REMS.

The Medication Guide tells patients:

  • If you decide to take an ESA, your healthcare provider should prescribe the smallest dose to lower the chance of getting red blood cell transfusions.
  • After you have finished your chemotherapy course, ESA treatment should be stopped.
  • ESAs do not improve the symptoms of anemia (lower than normal number of red blood cells), quality of life, fatigue, or well-being for patients with cancer.
  • You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with an ESA to a hemoglobin level above 12 g/dL.
  • You may get blood clots at any time while taking an ESA . If you are receiving ESA and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus).
  • Before ESA treatment begins, patients must sign an acknowledgment form that says they have talked with their healthcare professional about the risks of ESAs.

The APPRISE Oncology program requires that health care professionals who treat cancer patients with ESAs:

  • Complete a training module that covers the use of ESAs. Completion of the training module is required for enrollment in the ESA APPRISE Oncology program.
  • Sign the patient/healthcare professional acknowledgement form prior to the patient receiving an ESA. The acknowledgement form attests that the healthcare professional and patient have discussed the risks of using an ESA.
  • Re-enroll in the ESA APPRISE Oncology program every three years.

Only health care professionals who are part of APPRISE can prescribe ESAs for their cancer patients receiving chemotherapy.

Richard Pazdur, M.D., director of the Office of Oncology Products in the FDA’s Center for Drug Evaluation and Research said,

Evaluation of Erythropoiesis-Stimulating Agents has been an ongoing and intensive process since 2004, involving a series of public meetings, labeling changes, and a required Medication Guide. This new risk management program will help ensure that patients and their health care professionals have fully considered the benefits and risks of using ESAs.

Disclosure: C3 has accepted funding for projects and educational programs from Amgen in the form of unrestricted educational grants. C3 has ultimate authority over website content.

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