Introduction

2007

Special Announcement (Updated May 1, 2008): The US Food and Drug Administration (FDA) announced revisions to erythropoiesis-stimulating agent (ESA) product labels on November 8, 2007, when this guideline was in press. These revisions warn that data are not sufficient to exclude the possibility of shortened survival and tumor progression in cancer patients when ESAs are dosed to reach a hemoglobin (Hb) level between 10 and 12 g/dL. Clinicians are advised to consider this warning, as discussed in the guideline.

On March 12, 2008, the FDA posted the following information to its Website: "Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of greater than 12 g/dL."

For more information, visit http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA

To help doctors give their patients the best possible care, the American Society of Clinical Oncology (ASCO) asks its medical experts to develop recommendations for specific areas of cancer care. In 2002, ASCO and the American Society of Hematology (ASH) together published a clinical practice guideline about the use of epoetin (Epogen, Procrit) for chemotherapy-related anemia. This guideline was expanded and updated in 2007 to include a similar medication, called darbepoetin (Aranesp). This patient guide is based on the ASCO/ASH recommendations.

As you read this guide, please keep in mind that every person treated for cancer is different. These recommendations are not meant to replace your judgment or that of your doctor. The final decisions you and your doctors make will be based on your individual circumstances.

Information in ASCO’s patient education materials is not intended as medical advice or as a substitute for the treating doctor’s own professional judgment; nor does it imply ASCO endorsement of any product, service, or company.

Last Updated: February 20, 2008

| Next >