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

However, thrombotic events may be unrelated to the episode of chemotherapy and unrelated to the use of ESAs.

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The 2012 charges relate to development projects which have been discontinued or delayed.

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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We speculate that this is due to decreased production by endothelial cells of the macrophage-deactivating transforming growth factor-beta.

With drug independent autoantibodies, typified by alpha-methyl DOPA, IHA can persist at length, even after the drug is withdrawn.

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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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