ASH Guidelines

Epoetin and Darbepoetin

Special Announcement (Updated March 20, 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 Web site:

"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 = 12 g/dL."

"American Society of Hematology/American Society of Clinical Oncology 2007 clinical practice guideline update on the use of epoetin and darbepoetin"
The latest research and evidence-based clinical guidelines about the use of epoetin for the treatment of cancer-related anemia.

Epo Guideline Quick Reference
A quick reference for the "2007 Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin."

"Idiopathic thrombocytopenic purpura: A practice guideline developed by explicit methods for the American Society of Hematology"
This guideline is an evidence-based analysis of the diagnosis and management of idiopathic thrombocytopenic purpura (ITP) developed by a panel of specialists sponsored by ASH.

Other Guidelines

von Willebrand Disease

"von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA)"
This guideline was prepared by the National Heart, Lung, and Blood Institute and was published online in the journal Haemophilia on February 29, 2008. ASH is providing a link to this guideline as a service to our members.

Stem Cell Research

"Guidelines for the Conduct of Human Embryonic Stem Cell Research"
This guideline was developed by the International Society for Stem Cell Research and is endorsed by ASH.