epoetin beta




Zuellig Pharma
Concise Prescribing Info
Epoetin β
Anemia associated w/ chronic renal failure (CRF) in patients on dialysis. Symptomatic treatment of renal anemia in pre-dialysis patients. Anemia w/ solid tumours & treated w/ platinum-based chemotherapy prone to induce anemia. Symptomatic treatment of anemia w/ multiple myeloma, low grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia in adults w/ relative erythropoietin deficiency & receiving anti-tumor therapy. Increasing yield of autologous blood from patients in pre-donation program. Prevention of anaemia in premature infants <34 wk w/ 750-1,500 g birth wt.
Dosage/Direction for Use
Anemia w/ CRF Correction phase: SC inj Initially 3 x 20 IU/kg wkly, may be increased every 4 wk by 3 x 20 IU/kg wkly if increase is inadequate <0.25 g/dL wkly. Wkly dose can be divided into daily doses. IV inj Initially 3 x 40 IU/kg wkly, may be increased after 4 wk to 80 IU/kg 3 times wkly. Further increased at 20 IU/kg increments if needed 3 times wkly at mthly intervals. Max dose: Not to exceed 720 IU/kg wkly. Maintenance phase: Initially reduced to ½ of previously administered amount. Adjust dose subsequently at 2-4 wk intervals individually. Prevention of anemia of prematurity SC inj 3 x 250 IU/kg wkly for 6 wk. Symptomatic treatment of anemia in cancer SC inj Initially 30,000 IU wkly (approx 450 IU/kg wkly based on ave wt) for 4 wk. If Hb value increased by at least 1 g/dL, continue therapy; if not, double wkly dose. After 8 wk therapy, if Hb value has not increased by at least 1 g/dL, discontinue therapy. Continue therapy up to 4 wk after end of chemotherapy. Max: Not to exceed 60,000 IU wkly. Increasing amount of autologous blood SC/IV inj Individualized dosage administered twice wkly over 4 wk. Max IV dose: 1,600 IU/kg wkly. Max SC dose: 1,200 IU/kg wkly.
Hypersensitivity. Poorly controlled HTN. MI or stroke, unstable angina pectoris, at risk of DVT eg, history of venous thromboembolic disease.
Special Precautions
Severe cutaneous adverse reactions. Discontinue use if pure red cell aplasia is diagnosed. Presence of refractory anemia w/ excess blasts in transformation, epilepsy, thrombocytosis. Phenylketonuria. Fe deficiency; chronic inflammation; chronic blood loss, bone marrow fibrosis, severe Al overload, hemolysis; sudden stabbing migraine-like headache. Nephrosclerotic patients not yet undergoing dialysis. May stimulate growth of malignancy. Evaluate Fe status prior to & during treatment. Rule out folic acid & vit B12 deficiencies prior to treatment. Monitor platelet count, serum K, haematocrit/Hb levels & BP regularly. Chronic hepatic failure. Pregnancy & lactation. Not to be used in infants <2 yr.
Adverse Reactions
HTN, hypertensive crisis w/ or w/o encephalopathy-like symptoms eg, headaches, confused state, sensorimotor disorders; thromboembolic event.
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Recormon inj (pre-filled syringe) 4,000 IU/0.3 mL
Recormon inj (pre-filled syringe) 2,000 IU/0.3 mL
Recormon inj (pre-filled syringe) 5,000 IU/0.3 mL
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