One of the more common side effects of chemotherapy is anemia, or the lack of hemoglobin (red blood cells). Severe anemia is dangerous and will require the suspension of the use of chemotherapy as well as immediate treatment.

In light of this the U.S. Food and Drug Administration (FDA) has required that Amgen Inc. developed and approved a risk management program to inform both healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs) which are used to treat anemia resulting from chemotherapy (including advanced prostate cancer survivors).

These drugs, ESAs, which include epoetin alfa (marketed as Procrit and Epogen) and darbepoetin alfa (marketed as Aranesp), are manufactured by Amgen Inc. They are forms of the human protein erythropoietin, which stimulates bone marrow to make red blood cells.

The FDA required Amgen Inc. in 2008 to establish this risk management program based on studies that found that ESAs caused tumors to grow faster and resulted in earlier deaths in some cancer patients.

Amgen’s management program, Risk Evaluation and Mitigation Strategy (REMS), requires health care professionals to provide their patients receiving an ESA with a Medication Guide that contains information for patients on how to safely use a drug.

In addition, the company’s APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) program, which is part of the REMS, requires specific training and certification of health care professionals who administer chemotherapy to patients with cancer (including men with advanced prostate cancer) and counseling of their patients.

This management program, “Evaluation of Erythropoiesis-Stimulating Agents has been an ongoing and intensive process since 2004. Its goal is to ensure that patients and their health care professionals have fully considered the benefits and risks of using ESAs.”

Through the risk management program, Amgen must ensure that health care professionals who treat patients with cancer do the following:

• Register and maintain active enrollment in the ESA APPRISE program,
• Complete a special training module on how to use ESAs in patients with cancer, and
• Discuss the risks, benefits, and FDA-approved uses of ESAs with patients who have cancer before beginning a course of ESA
treatment and document this discussion with a written acknowledgement from the patient.

The FDA also requires that Amgen oversee and monitor health care professionals and hospitals that use ESAs for patients with cancer to ensure that these caregivers are fully compliant with all aspects of the overall risk management program.

For more information:

Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp

The current guideline Safety now recommends initiating ESAs at hemoglobin (Hb) levels <10 g/dL (US) or <= 10 g/dL (EU)."You should be aware of the symptoms of anemia may include the following: • fatigue; • decreased energy; • weakness; • shortness of breath; • lightheadedness; • palpitations (feeling of the heart racing or beating irregularly); and • looking pale.Symptoms of severe anemia may include: • chest pain, angina, or heart attack; • dizziness; • fainting or passing out; and • rapid heart rate.Some of the signs that may indicate anemia in an individual may include: • Change in stool color, including black and tarry stools (sticky and foul smelling), maroon-colored, or visibly bloody stools if the anemia is due to blood loss through the gastrointestinal tract; • rapid heart rate; • low blood pressure; • rapid breathing; • pale or cold skin; • yellow skin called jaundice if anemia is due to red blood cell breakdown; • heart murmur; and • enlargement of the spleen with certain causes of anemia.Men, with advanced prostate cancer and receiving chemotherapy who experience these symptoms must contact their doctor and report them. Any man experiencing the severe symptoms should immediately proceed to an emergency room.Joel T. Nowak, M.A., M.S.W.