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CAUTION ABOUT USE OF ERYTHROPOIETIN PRODUCTS
By Brian G.M. Durie, MD
Several recent public health advisories and safety messages have raised cautions about the use of Darbopoetin alfa (Aranesp®) and Epoetin alfa (Procrit® and Epogen®). These drugs are used to stimulate red blood cell production to reverse anemia.
03.28.07

Several recent public health advisories and safety messages have raised cautions about the use of Darbopoetin alfa (Aranesp®) and Epoetin alfa (Procrit® and Epogen®). These drugs are used to stimulate red blood cell production to reverse anemia. The specific situation that has raised concern is anemia related to cancers, including myeloma, being treated with Aranesp®, Procrit®, or Epogen® in the absence of any ongoing active treatment from the underlying myeloma. The recent study with Aranesp indicated that in this situation the use of the Aranesp may have contributed to a poorer outcome. Right now the reasons for this are unclear. However, based upon these data, the Centers for Medicare and Medicaid Services (CMS) has issued an instruction to prohibit Medicare coverage for Aranesp®, Procrit®, and Epogen® in this setting identified as ICD-9 code 285-22. This is obviously an important step. Coverage for use in other settings remains in effect; most importantly, "anemia due to ongoing active therapy." There are separate clauses allowing coverage for use to stimulate red blood cell production for 3 months after stem cell or bone marrow transplant; in the setting of renal insufficiency or failure; and in some other special situations such as HIV infection.

Some nuances of coverage are still being sorted out. What is "active therapy"? Is this just "chemotherapy"? By most, this is assumed to also include new drugs such as Revlimid® (lenalidomide), Thalomid® (thalidomide), and Velcade® (bortezomib).

Myeloma patients are strongly encouraged to discuss any ongoing or planned use of Aranesp®, Procrit®, and Epogen® directly with their treating physicians. It is important to make sure there is not any increased risk with use for each individual patient as well as making sure about reimbursement of costs.

The IMF will keep you posted as to new developments.

Please see the links below for further details.

FDA Public Health Advisory
Epoetin alfa (marketed as Procrit, Epogen)
Darbepoetin alfa (marketed as Aranesp)

FDA Public Health Advisory Update
Erythropoiesis-Stimulating Agents (ESAs)

FDA Information for Healthcare Professionals
Erythropoiesis Stimulating Agents (ESA)
[Aranesp (darbepoetin), Epogen (epoetin alfa), and Procrit (epoetin alfa)]

Ortho Biotech's Procrit Safety Update
Boxed Warning
You can also visit www.procrit.com or call 1 888 2ASK OBI or 1-888-227-5624.

Amgen's Update to U.S. Prescribing Information for Aranesp® and EPOGEN®
Includes prescribing information and statement of safety.


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