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Hypertensive encephalopathy and seizures have been observed in patients with CRF treated with Aranesp ä or Epoetin alfa.

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The use of erythropoietin has resulted in profound improvements in the health and quality of life of dialysis patients and has been a landmark achievement in the care of end-stage renal disease patients.

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Investigators have documented that the transient, supraphysiologic levels of hormone seen with erythropoietin injection produces hypochromic red cells similar to those seen with frank iron deficiency (Madore, et al.

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Iron stores were quite high in these early subject all of whom had been on maintenance transfusion therapy prior to the introduction of erythropoietin.

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This, Lappin noted, is significant because it suggests the potential use of erythropoietin receptors of a tumor to target an erythropoietin-attached drug to the tumor and not damage the surrounding healthy tissue (Farrell 2004).

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There were no new safety signals for epoetin alfa from the study and safety findings were consistent with the known safety profile of epoetin alfa.

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Less frequent dosing regimens, although equivalent to more frequent dosing regimens on the basis of a hematologic response, result in higher peak blood levels of hormone (Chung 1998, 2001; Kryzunski 2005; Ramakrishnan 2004).

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The investigator will adjust epoetin doses as per the study algorithm during the run-in (every two weeks) and active phases (every four weeks).

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