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Chronic renal failure patients: In patients with chronic renal failure, where intravenous access is routinely available (haemodialysis patients) administration of EPODION by the intravenous route is preferable. Where intravenous access is not readily available (patients not yet on dialysis and peritoneal dialysis patients) EPODION may be administered subcutaneously. The recommended desired haemoglobin concentration range is between 10 g/dL to 12 g/dL (6.2-7.5 mmol/L) in adults. In patients with chronic renal failure and clinically evident ischaemic heart disease or congestive heart failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration. Iron status should be evaluated prior to and during treatment and iron supplementation should be administered if necessary. Other causes of anaemia (folate or Vitamin B12 deficiency) should be excluded before starting therapy with EPODION. Non-response to EPODION therapy should prompt a search for causative factors. These include: iron, folate or Vitamin B12 deficiency, aluminium intoxication, intercurrent infections; inflammatory or traumatic episodes, blood loss, haemolysis and bone marrow fibrosis of any origin.
Adult haemodialysis patients: In patients on haemodialysis where intravenous access is readily available, administration by intravenous route is preferable.
The treatment is divided into two stages: Correction phase: The starting dose is 50 IU/kg, 3 times per week. If necessary, increase or decrease the dose by 25 IU/kg (3 times per week) until the desired haemoglobin concentration range between 10 g/dL to 12 g/dL (6.2-7.5 mmol/L) is achieved (this should be done in steps of at least four weeks).
Maintenance phase: The maintenance dose should be individualized for each chronic renal failure patient. The recommended total weekly dose is between 75 IU/kg and 300 IU/kg. Appropriate adjustment of the dose should be made in order to maintain haemoglobin values within the desired concentration range between 10 g/dL to 12 g/dL (6.2-7.5 mmol/L). Patients with very low initial haemoglobin (<6 g/dL or <3.75 mmol/L) may require higher maintenance doses than patients whose initial anaemia is less severe (>8 g/dL or >5 mmol/L).
Adult peritoneal dialysis patients: Where intravenous access is not readily available, EPODION may be administered subcutaneously.
Correction phase: The starting dose is 50 IU/kg, 3 times per week. If necessary, increase or decrease the dose by 25 IU/kg (3 times per week) until the desired haemoglobin concentration range between 10 g/dL to 12 g/dL (6.2-7.5 mmol/L) is achieved (this should be done in steps of at least four weeks).
Maintenance phase: The usual dose to maintain the target haemoglobin is between 17 and 33 IU/kg three times per week. The maximum dosage should not exceed 200 IU/kg three times per week. Appropriate adjustment of the dose should be made in order to maintain haemoglobin values at the desired level between 10 g/dL to 12 g/dL (6.2-7.5 mmol/L).
Adult patients with renal insufficiency not yet undergoing dialysis: Where intravenous access is not readily available, EPODION may be administered subcutaneously.
Correction phase: Starting dose of 50 IU/kg, 3 times per week, followed if necessary by a dosage increase with 25 IU/kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
Maintenance phase: During the maintenance phase, EPODION can be administered either 3 times per week or in the case of subcutaneous administration, once weekly or once every 2 weeks. Appropriate adjustment of dose and dose intervals should be made in order to maintain haemoglobin values at the desired level: haemoglobin between 10 g/dL and 12 g/dL (6.2-7.5 mmol/L). The recommended dosage adjustment is between 17 and 33 IU/kg three times per week. The maximum dosage should not exceed 200 IU/kg three times per week.
Treatment of adult patients with chemotherapy-induced anaemia: EPODION should be administered to patients with anaemia (e.g. haemoglobin concentration ≤10.5 g/dL (6.5 mmol/L)). The subcutaneous route of administration should be used. The target haemoglobin concentration should be up to 12 g/dL (7.5 mmol/L) in men and women and it should not be exceeded. EPODION therapy should continue until one month after the end of chemotherapy. However, the need to continue EPODION therapy should be re-evaluated periodically.
The initial dose is 150 IU/kg subcutaneously, 3 times per week. If the haemoglobin concentration has increased by at least 1 g/dL (0.62 mmol/L) or the reticulocyte count has increased ≥40,000 cells/µL above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week. If the haemoglobin concentration has not increased by ≥1 g/dL (≥0.62 mmol/L) and the reticulocyte count has not increased by ≥40,000 cells/µL above baseline after 4 weeks of treatment, at the initial dose should be increased to 300 IU/kg 3 times per week. If after an additional 4 weeks of therapy at 300 IU/kg 3 times per week, the haemoglobin concentration has increased ≥1 g/dL (≥0.62 mmol/L) or the reticulocyte count has increased ≥40,000 cells/µL, the dose should remain at 300 IU/kg 3 times per week.
If after an additional 4 weeks of therapy at 300 IU/kg 3 times per week, haemoglobin concentration has increased <1 g/dL (<0.62 mmol/L) and the reticulocyte count has increased <40,000 cells/µL above baseline after an additional 4 weeks of therapy, response is unlikely and treatment should be discontinued.
[The recommended dosing regimen is described in the following diagram: (See figure)].
Click on icon to see table/diagram/imageA rate of rise in haemoglobin of greater than 2 g/dL (1.25 mmol/L) per month should be avoided.
If the haemoglobin concentration is increasing by more than 2 g/dL (1.25 mmol/L) per month, or if the haemoglobin concentration level exceeds 12 g/dL (7.5 mmol/L), reduce the EPODION dose by about 25 to 50%. If the haemoglobin concentration level exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinitiate EPODION therapy at a dose 25% below the previous dose.
Treatment of adult surgery patients in an autologous predonation programme: The intravenous route of administration should be used. EPODION should be administered after the completion of the blood donation procedure. For patients in an autologous predonation programme, iron supplementation (elemental iron 200 mg/day orally) should be administered several weeks prior to initiating the autologous predeposit in order to achieve high iron stores prior to starting Epoetin alfa therapy, and throughout the course of Epoetin alfa therapy. Mildly anaemic patients (haematocrit of 33 to 39% and/or haemoglobin 10 to 13 g/dL) requiring predeposit of ≥4 units of blood should be treated with EPODION 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Perisurgery patients without autologous blood donation: The subcutaneous route of administration should be used. Patient should receive adequate iron supplementation (at least 200 mg/daily orally) which should be initiated no later than the beginning of treatment with EPODION and should continue throughout the course of therapy. Recommended dosage regimen is 600 IU/kg of EPODION given weekly for three weeks, days -21, -14 and -7 prior to surgery and on the day of surgery.
Treatment of adult patients scheduled for major elective orthopaedic surgery: The subcutaneous route of administration should be used. The recommended dose is EPODION 600 IU/kg administered subcutaneously weekly for three weeks (days -21, -14 and -7) prior to surgery and on the day of surgery. For patients scheduled for major elective orthopaedic surgery, iron supplementation (elemental iron 200 mg/day orally) should be administered throughout the course of Epoetin alfa therapy. If possible, iron supplementation should be initiated prior to starting Epoetin alfa therapy to achieve adequate iron stores. In cases where there is a medical need to shorten the lead time before surgery to less than three weeks, EPODION 300 IU/kg should be administered subcutaneously daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter. If the haemoglobin level reaches 15 g/dL, or higher, during the preoperative period, administration of EPODION should be stopped and further dosages should not be administered. Care should be taken to ensure that at the outset of the treatment patients are not iron deficient.
HIV-infected patients being treated with AZT (Zidovudine): Prior to beginning EPODION therapy, it is recommended that the endogenous serum erythropoietin level be determined (prior to transfusion). Available evidence suggests that patients receiving zidovudine with levels >500 mU/mL are unlikely to respond to therapy with EPODION unless the dose of zidovudine is reduced or temporarily stopped.
Starting Dose: For patients with serum erythropoietin levels ≤500 mU/mL, the recommended starting dose of EPODION is 100 IU/kg as an intravenous or subcutaneous injection three times weekly for eight weeks.
Increase Dose: During the dose adjustment phase of therapy, the haemoglobin should be monitored weekly. If the response is not satisfactory in terms of reducing transfusion requirements or increasing haemoglobin after eight weeks of therapy, the dose of EPODION can be increased by 50-100 IU/kg three times per week. Response should be evaluated every 4-8 weeks thereafter and the dose adjusted accordingly by 50-100 IU/kg increments three times per week. If patients have not responded satisfactorily to an EPODION dose of 300 IU/kg three times per week up to month 12 of therapy, further continuation of treatment is not warranted as it is unlikely that they will respond to higher doses of EPODION.
Maintenance Dose: After attainment of the desired response (i.e., reduced transfusion requirements or increased haemoglobin), the dose of EPODION should be titrated to maintain the response based on factors such as variations in zidovudine dose and the presence of intercurrent infectious or inflammatory episodes. If the haemoglobin exceeds 12 g/dL, the dose should be temporarily withheld until the haemoglobin falls below 12 g/dL. Resume dosing at 25% less than the previous dose and titrate the dose to maintain the desired haemoglobin.
Haemoglobin Range: Maximum benefit from EPODION therapy appears to occur when the haemoglobin is maintained in the range of 12-13 g/dL; however, the haemoglobin for zidovudine-treated/HIV-infected patients should not exceed 12 g/dL.
