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Eposis Injection (Epoetin alfa)

  • Each 1 mL of solution contains 2000, 4000, 5000 or 10,000 Units of Epoetin alfa.
  • Treatment of anaemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis, Zidovudine in HIV-infected patients, the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
  • Epoetin alfa is a glycoprotein, produced by recombinant DNA technology. It induces erythropoiesis by stimulating the division and differentiation of committed erythroid progenitor cells, including burst-forming units erythroid, colony-forming units erythroid, erythroblasts, and reticulocytes, in bone marrow.
  • CKD Patients: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (children on dialysis). Individualize maintenance dose. Intravenous route recommended for patients on haemodialysis. Zidovudine-treated HIV-infected Patients: 100 Units/kg 3 times weekly. Cancer Patients on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (children ≥ 5 years). Surgery Patients: 300 Units/kg per day daily for 14 days or 600 Units/kg weekly.
  • Uncontrolled hypertension. Pure red cell aplasia (PRCA) that begins after treatment or other erythropoietin protein drugs. Serious allergic reactions. Use of the multi-dose vials in neonates, infants, pregnant women, and nursing mothers.
  • Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer. Hypertension, Seizures & pure red cell aplasia.
  • Pregnancy Category C (single-dose vials only) There are no adequate and well-controlled studies of use during pregnancy. It is not known whether Eposis is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Eposis from single-dose vials is administered to a nursing woman. Safety and effectiveness have not been established in CKD patients undergoing dialysis who are less than 1 month old, paediatric patients with cancer less than 5 years old, paediatric patients with CKD not on dialysis, and paediatric patients with HIV infection.
  • An increase in heparin dosage may be required in patients receiving haemodialysis, because epoetin-induced increases in red blood cell volume may lead to blood clotting in the dialyzer and/or vascular access.
  • Adverse reactions in ≥ 5% of Eposis-treated patients in clinical studies were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
  • Store at 2 to 8 degrees C (36 to 46 degrees F). Do not freeze or shake.
  • Anaemia Management and Haematinics