Erythropoiesis-stimulating agents (ESAs) increased the risk of serious cardiovascular events, thromboembolic events, and mortality in clinical studies; a rapid rise in hemoglobin (>1 g/dL over 2 weeks) or maintaining higher hemoglobin levels may contribute to these risks. Cases of severe anemia and pure red cell aplasia reported. A shortened overall survival and/or increased risk of tumor progression or recurrence reported in studies with breast, cervical, head and neck, lymphoid, and non-small cell lung cancer patients. ESAs not indicated for patients receiving myelosuppressive therapy when anticipated outcome is curative. Increased risk of death and serious cardiovascular events reported in patients administered ESAs to target higher vs lower hemoglobin levels in two clinical studies. Hypertensive encephalopathy reported in patients receiving erythropoietic therapy. Epoetin not approved for reduction of red blood cell transfusion in patients undergoing cardiac or vascular surgery. Use caution with porphyria (exacerbation of porphyria reported in chronic renal failure). Use with caution in history of seizures. An excessive rate of rise of hemoglobin may possibly be associated with exacerbation of seizures. Product may contain albumin, which confers a theoretical risk of transmission of viral disease or Creutzfeldt-Jakob disease. Multidose vials contain benzyl alcohol, associated with «gasping syndrome» in neonates. Not recommended for acute correction of severe anemia or as a substitute for transfusion. Supplemental iron recommended if serum ferritin <100 µg/L or serum transferrin saturation <20%.