Potentially serious allergic reactions may occur (rash and urticaria). Cases of severe anemia and pure red cell aplasia reported, predominantly in patients with chronic renal failure receiving SubQ darbepoetin (the I.V. route is preferred for hemodialysis patients). Therapy with darbepoetin and other erythropoiesis-stimulating agents may increase risk of death and serious cardiovascular events (myocardial infarction, stroke, congestive heart failure, hemodialysis graft occlusion) when targeted to hemoglobin concentrations exceeding 12 g/dL (chronic renal failure patients or undergoing coronary artery bypass surgery may be at a higher risk for cardiovascular and mortality events). An increased incidence of thromboembolic events (e.g. pulmonary embolism, thromboembolism, thrombophlebitis, thrombosis) observed in cancer patients receiving darbepoetin (not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is curative). Caution in history of hypertension or history of seizures. May contain albumin and latex (theoretical risk of transmission of viral disease or Creutzfeldt-Jakob disease). Correct deficiencies of iron, vitamin B~12~, and/or folate, as well as other factors which may impair erythropoiesis (aluminum toxicity, inflammatory conditions, infections) prior to initiating treatment. Hemoglobin levels should not exceed a target range of 10-12 g/dL and should not rise >1 g/dL per 2-week time period during therapy in any patient. Solution should not be shaken.