Biocare Lifesciences


Concise Prescribing Info
Recombinant human erythropoietin
Anaemia associated w/ chronic renal failure in adult haemodialysis, peritoneal dialysis & predialysis patients (PD) w/ renal insufficiency. Anemia & reduction of transfusion requirements in adults receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma & at risk of transfusion. Facilitates autologous blood collection w/in a predonation program in patients w/ moderate anemia. Reduces risk of exposure to allogenic blood transfusion in non-Fe adults who are receiving major elective orthopedic surgery.
Dosage/Direction for Use
Chronic renal failure IV/SC Adult 50-100 IU/kg 3 times wkly, childn 25-50 IU kg 3 times wkly. Correction phase: 50 IU/kg 3 times wkly. Adjust dose in increments of 25 IU/kg 3 times wkly at intervals of at least 4 wk until target Hb conc achieved. Maintenance phase: total wkly dose is 75-300 IU/kg. Treatment of anemia in adult cancer patient SC Initially 150 IU/kg 3 times wkly. Increase dose to 300 IU/kg 3 times wkly if Hb increase is <1 mg/dL and reticulocyte count increased <40,000 cells/μL. Adult surgery patient in an autologous predonation program IV 300-600 IU/kg twice wkly for 3 wk. Elective surgery in adult patient SC 600 IU kg for 3 wk (days 21, 14 & 7) prior & the day of surgery. If shortened surgery of <3 wk, administer 300 IU/kg daily for 10 consecutive days prior & on the day of surgery, & 4 days post-surgery.
Hypersensitivity to human albumin & products from mammalian cells. Patients who develop pure red cell aplasia w/ any erythropoetin. Patients scheduled for major elective surgery, not participating in autologous blood predonation program & not having CAD, peripheral artery disease, carotid arterial disease or stroke, including patients w/ recent MI or stroke. Surgery patients who cannot receive adequate antithrombotic prophylaxis.
Special Precautions
Adequately control BP prior to treatment initiation. Monitor serum electrolytes, CBC & platelet count during treatment in patients w/ chronic renal failure. Evaluate levels of Fe & serum ferritin prior & during treatment. History of seizures, epilepsy, chronic liver failure & underlying hematologic disease. Discontinue of hyperkalemia occurs. Increased risk of cardiovascular & thrombotic events. Immunogenicity. Investigate when decrease in therapeutic response & discontinue use when suspected for pure red blood cells aplasia. Avoid switching to another erythropoiesis-stimulating agents. Immunogenicity. Childn. Pregnancy & lactation.
Adverse Reactions
Increased BP, aggravation of preexisting HTN. Hypertensive crisis w/ encephalopathy. Sudden stabbing migraine-like headache.
Drug Interactions
Concomitant use w/ another anti-anemic drugs. Cyclosporin.
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Epocare 4000 soln for inj 4000 IU/mL
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