Greater risks for death, serious CV events & stroke if administered in patients w/ chronic renal failure to target Hb levels of ≥13 g/dL. Shortened overall survival &/or increased risk of tumor progression or recurrence in patients w/ breast, non-small cell lung, head & neck, lymphoid, & cervical cancers. Use only for treatment of anaemia due to concomitant myelosuppressive chemotherapy. Not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure; discontinue following the completion of chemotherapy course. Increased rate of DVT in patients not receiving prophylactic anticoagulation. Pure red cell aplasia (PRCA) & severe anaemia, w/ or w/o other cytopenias, associated w/ neutralizing Abs may occur, predominantly when administered by SC in patients w/ chronic failure. PRCA in patients while undergoing treatment for hepatitis C w/ interferon & ribavirin. Evaluate for the etiology of loss in effect including the presence of neutralizing Abs in any patients who develops a sudden loss of response to treatment accompanied by severe anaemia & low reticulocyte count. Permanently discontinue in patients w/ Ab-mediated anaemia. Abs may cross-react w/ other erythropoiesis-stimulating agents. Regularly monitor hematocrit (once a wk in initial treatment phase & twice a wk in maintenance phase) to avoid excessive erythropoiesis & Hb (once every 1-2 wk) when 36,000 IU/mL is used; discontinue if excessive erythropoiesis it occurs or Hb is >120 g/L. Patients w/ known porphyria. Absolute or functional Fe deficiency may develop. Evaluate Fe status, including transferrin saturation & serum ferritin prior to & during therapy. Surgery patients should receive adequate Fe supplementation throughout the course of therapy to support erythropoiesis & avoid depletion of Fe stores. Adequately control BP before initiation of therapy; decrease or w/hold dose if BP is difficult to control. Carefully adjust dose to achieve & maintain HB levels between 10-12 g/dL in chronic renal failure patients on hemodialysis w/ clinically evident ischemic heart disease or CHF. Known history of seizure disorder or underlying hematologic disease (eg, sickle cell anaemia, myelodysplastic syndromes, or hypercoagulable disorders). Treated patients may require increased anticoagulation w/ heparin to prevent clotting of the artificial kidney during hemodialysis. Increased risk of thrombotic events including vascular access thrombosis in adult patients w/ ischemic heart disease or CHF receiving therapy w/ goal of reaching a normal hematocrit (42%). Monitor closely the presence of premonitory neurologic symptoms; pre-existing CV disease. Patients w/ symptoms of cardiac infarction, pulmonary infarction, cerebral infarction or those w/ allergic history of drugs & manifestation of allergy. May diminish efficacy w/ folic acid or vit B
12 deficiency; Al intoxication. Avoid potentially hazardous activities eg, driving or operating heavy machinery. Pregnancy & lactation. Premature infants, newborns, & infants. Elderly.