ASCO Patient Guide: Epoetin and Darbepoetin Treatment

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ASCO Patient Guide: Epoetin and Darbepoetin Treatment

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

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Background

Anemia is a low level of red blood cells, or of hemoglobin, which is the oxygen-carrying part of the red blood cell. Epoetin and darbepoetin are drugs that help treat anemia caused by chemotherapy. They are similar to the hormone erythropoietin. Erythropoietin is made in the body naturally, and it helps the bone marrow produce more red blood cells. When the levels of red blood cells and/or hemoglobin decrease, the body has to work harder to move oxygen, which can cause fatigue, muscle weakness, and difficulty breathing.

People with anemia have a blood test that shows decreased amounts of hemoglobin in the blood. Normal levels of hemoglobin are 12 to 18 grams per deciliter (g/dL), with men naturally having slightly higher levels than women. Depending on the underlying cause, anemia may be treated with a variety of approaches, including finding the cause of anemia and reversing it, or other specific treatments, such as iron, folate, or vitamin B6 or B12 supplements; a blood transfusion; or with epoetin or darbepoetin. Epoetin and darbepoetin are given as a series of injections (shots) and can reduce the need for red blood cell transfusions and increase hemoglobin levels. However, these drugs also have risks, including the risk of serious or life-threatening blood clots.

In March 2007, the FDA issued a public health advisory about the safety of epoetin and darbepoetin. This advisory warned that these medications increased the risk of death when they were given to people with cancer who were anemic but not undergoing active treatment with chemotherapy, and when they were used to raise hemoglobin levels to more than 12 g/dL. The labeling of these drugs was updated with these changes, and the ASCO/ASH recommendations reflect these changes.

Last Updated: February 20, 2008

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Recommendations

The ASCO/ASH recommendations for epoetin and darbepoetin treatment are as follows:

Epoetin and darbepoetin are equal in terms of effectiveness and safety when used to treat chemotherapy-associated anemia. These drugs may also be considered for some patients with low-risk myelodysplastic syndrome (MDS), a disorder of the bone marrow that may cause anemia. However, epoetin and darbepoetin should not be used to treat anemia in patients with cancer who are no longer receiving chemotherapy.
The doctor may choose to begin treatment earlier, when the hemoglobin level is between 10 g/dL and 12 g/dL, for patients with other medical conditions affected by anemia (such as heart disease) or those who have difficulties performing regular daily activities,. The doses of these drugs may need to be adjusted over time, so that the hemoglobin level remains high enough for the patient to avoid a blood transfusion but remains under 12 g/dL. Levels higher than 12 g/dL, when produced with these drugs, may create serious health risks. (People with normal levels of hemoglobin higher than 12 g/dL do not have these same risks.) Iron supplements, given either intravenously (IV, through a vein) or by mouth, may improve the effectiveness of epoetin and darbepoetin.
Doctors and patients should weigh the risks and benefits of these drugs for patients at high risk for developing blood clots. Risk factors include a previous blood clot, recent major surgery, long periods of bed rest or limited activity (such as being in the hospital), and certain types of chemotherapy and hormone therapy. Patients receiving some types of treatment for multiple myeloma (especially thalidomide [Thalomid] or similar drugs) may also have a higher risk of developing a blood clot. For more information, read the ASCO Patient Guide: Preventing and Treating Blood Clots.
If the hemoglobin levels aren’t rising after four to six weeks of treatment with one of these drugs, the doctor may consider increasing the dose, as recommended in the labeling of the drug. If hemoglobin levels still do not rise after another four weeks, then ESA treatment should stop.

Last Updated: February 20, 2008

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