FDA Video: Risk Management Program for Procrit, Epogen and Aranesp
FDA is requiring that Erythropoiesis-Stimulating Agents (ESAs) be prescribed and used under a special risk management program. This program is designed to inform healthcare providers and their patients about the risks of these drugs and to ensure that they're administered appropriately when they're used to treat cancer patients for anemia.
ESAs, sold as Procrit (epoetin alfa), Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), and stimulate the bone marrow to produce red blood cells. They're approved to treat anemia resulting from chemotherapy, chronic kidney failure and some HIV treatments, and also to reduce the number of blood transfusions during and after certain major surgeries.
Studies have shown that ESAs can increase the risk of tumor growth and shorten survival in cancer patients. Also, any patient treated with these drugs may have a higher risk of heart attack, heart failure, stroke or blood clots.
The risk management program requires health care professionals to provide patients receiving an ESA with a Medication Guide that contains information on how to safely use the drug. In addition, Amgen, the manufacturer of the three products, will oversee a training and certification program called APPRISE for health care professionals who administer chemotherapy to patients with cancer. Providers who treat these patients with ESAs must register and maintain active enrollment in the APPRISE program and complete a special training module on how to use ESAs in patients with cancer. They must also discuss the risks, benefits, and FDA-approved uses of ESAs with patients and document their discussion with a written acknowledgement from the patient. The APPRISE program does not apply to patients treated with an ESA for conditions other than cancer.