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Alert Number 151

Aranesp Safety Warning

Date: February 16, 2006

Aranesp is a growth factor that is used quite often in CLL patients, in an attempt to boost red cell production. There is new warning issued by the FDA with respect to this drug. Even if you do not presently take Aranesp, you should be aware of the development for future reference. At the risk of sounding like a broken record, none of the drugs or growth factors we have to use to control the CLL and its side effects is entirely harmless. I am getting the distinct impression that it is not a good idea to double up on some of these drugs, either in dosage or frequency, under the assumption that more is better.

Aranesp is a man-made version of the red blood cell growth factor that the body makes. Think of this growth factor as the order sent to the factory (your bone marrow) to make more red blood cells. The Medscape article below reports that in some cases, the immune system develops antibodies to the man-made drug, neutralizing it before it can be acted upon by the bone marrow. But that is only the tip of the iceberg. It seems that the immune system goes one step further, it is not just the man-made version that is neutralized, even the home grown version of it made by the body is also neutralized. Without the necessary growth factor signal, red blood cell production may shut down. This can lead to deep seated and potentially life threatening anemia. The bad news is that the resistance to Aranesp may extend to other erythropoietin drugs as well.

Talk about a rock and a hard place. This is just one more aspect of the penchant CLL patients have to all sorts of autoimmune diseases, where we develop antibodies to perfectly good and necessary proteins. The moral of the story is quite simple. Think twice before you push your doctor to give you more shots than you really need. There is a dark side to “epo”, as we discussed in a prior article on our website: The Dark Side of Epoetin

Frequently doctors go along with a patient's request, if for no other reason than to get the pushy patient out of their hair. While higher hemoglobin and red blood cell levels give a boost to energy and general feeling of well being in the short run, you may be using up your markers faster than you would want to. Fighting CLL is a long term process, and part of the strategy is not to burn too many bridges early on. Becoming resistant to natural or man-made erythropoietin is serious business, it means becoming dependent on transfusions of red blood cells to continue living.

Be well,

Chaya
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Report

FDA Safety Changes: Aranesp

News Author: Yael Waknine

Release Date: February 15, 2006;

Darbepoetin Alfa (Aranesp) Linked to Risks for Pure Red Cell Aplasia and Anemia

On October 26, 2005, the FDA approved safety labeling revisions for darbepoetin alfa injection (Aranesp, made by Amgen, Inc) to reflect postmarketing reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with the development of neutralizing antibodies to erythropoietin in patients receiving the product.

Although these events have occurred predominantly in patients with chronic renal failure receiving darbepoetin alfa by subcutaneous injection, any patient who develops a sudden loss of response accompanied by severe anemia and low reticulocyte counts should be evaluated for causative factors.

Causative etiologies to be considered include iron deficiency; underlying infectious, inflammatory, or malignant processes; occult blood loss; underlying hematologic diseases, such as thalassemia, refractory anemia, or other myelodysplastic disorders; folic acid/vitamin B12 deficiencies; hemolysis; aluminum intoxication; and osteitis fibrosa cystica.

In the absence of another etiology, patients should be evaluated for evidence of pure red cell aplasia and undergo serum testing for antibodies to erythropoietin. Assays for binding and neutralizing antibodies may be requested from the manufacturer by telephone at 1-800-77AMGEN (1-800-772-6436).

All treatment with darbepoetin alfa and other erythropoietic proteins should be withheld in patients with suspected antibody-related anemia and permanently discontinued on diagnostic confirmation. Because of the potential for antibody cross-reactivity, switching patients from one therapy to another is not recommended.

Darbepoetin alfa is indicated for the treatment of chronic renal failure-related anemia in dialysis and nondialysis patients and chemotherapy-related anemia in patients with nonmyeloid malignancies.

This article is intended for primary care clinicians, pediatricians, infectious disease specialists, nephrologists, oncologists, surgeons, obstetrics/gynecologists, and other specialists who care for patients with infections, anemia due to chronic renal failure, or chemotherapy or who require local or regional anesthesia.
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