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This observation provided the basis for a warning on the label for darbepoetin alfa (and eventually a stronger warning on the label for epoetin alfa) regarding excessive rates of increase in hemoglobin concentrations.
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Erythropoiesis-stimulating agent slows the progression of chronic kidney disease: a possibility of a direct action of erythropoietin.
Significantly fewer patients treated with epoetin alfa than SOC reported fatigue as an adverse event.
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Affected individuals develop peripheral vein varicosities, hypertension and increased vascular complications, including thrombotic events and a shorter lifespan ().
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The anemia of CKD is typically normochromic and normocytic and is caused primarily by a decrease in erythropoietin production relative to the degree of anemia.
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Another possibility, and one of long-standing concern to us at the FDA, is that the risk of cardiovascular events is related to the rapidity of the increase in hemoglobin concentration, as well as to oscillations in hemoglobin levels and overshoots of the target concentration; aggressive dosing can cause all these effects.
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The cells or organisms are used to produce certain complex proteins or molecules that are then used as medications, and the medications are known as "biologics" or "biopharmaceuticals.
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Food and Drug Administration: FDA announces new safety plan for agents used to treat chemotherapy-related anemia.
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PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of epoetin alfa with a placebo in treating anemia in cancer patients who are receiving chemotherapy.
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