The FDA has approved revised boxed warnings and safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. ESAs are a bio-engineered version of a protein made in the kidneys that stimulates bone marrow to produce more red blood cells.
A sampling of the new statements addresses the following:
The U.S. Food and Drug Administration (FDA) has approved methoxy polyethylene glycolepoetin beta (Mircera, Roche) for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients and in those not undergoing dialysis.
Mircera is the only FDA-approved erythropoiesis-stimulating agent (ESA) to help correct anemia with dosing once every two weeks and to maintain stable hemoglobin levels with once-monthly dosing or once-every-two-week dosing in all patients with CKD.
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