Epodion

Recombinant human erythropoietin α

Anemia associated w/ chronic renal failure in adult patients on haemodialysis & peritoneal dialysis. Severe anemia of renal origin accompanied by clinical symptoms in adult patients w/ renal insufficiency not yet undergoing dialysis. Anemia & reduction of transfusion requirements in adult patients receiving chemotherapy. Facilitates autologous blood collection w/in a predeposit programme & decreases risk of receiving allogeneic blood transfusions in patients w/ moderate anemia who are scheduled for major elective surgery & are expected to require more blood than that which can be obtained through autologous blood collection techniques in the absence of epoetin α. Augments erythropoiesis in perisurgical period to reduce allogeneic blood transfusions & correct post-op anemia in adult non-Fe deficient patients undergoing major elective orthopaedic surgery. Anemia in symptomatic HIV-infected patients being treated w/ AZT (zidovudine) & who are transfusion-dependent.

IV Adult Haemodialysis patient Correction phase: 50 IU/kg 3 times/wk. Adjust dose in 25 IU/kg-increments 3 times/wk at least 4-wk intervals until target Hb conc is achieved. Maintenance phase: Individualized dosage. Recommended total wkly dose: 75-300 IU/kg. Surgery patient in an autologous predonation programme 600 IU/kg, 2 times/wk for 3 wk prior to surgery. IV/SC Adult Peritoneal dialysis patient Correction phase: 50 IU/kg 3 times/wk. Adjust dose in 25 IU/kg-increments 3 times/wk at least 4-wk intervals until target Hb conc is achieved. Maintenance phase: 17-33 IU/kg 3 times/wk. Max: 200 IU/kg 3 times/wk. Patient w/ renal insufficiency not yet undergoing dialysis Correction phase: 50 IU/kg 3 times/wk. Adjust dose in 25 IU/kg-increments 3 times/wk at least 4-wk intervals. Maintenance phase: 17-33 IU/kg 3 times/wk. Max: 200 IU/kg 3 times/wk. HIV-infected patient treated w/ AZT (Zidovudine) Starting dose: 100 IU/kg 3 times/wk for 8 wk. The dose may be increased in 50-100 IU/kg-increments 3 times/wk before re-evaluation after 4-8 wk. Maintenance dose: Titrate dose to maintain the desired response. If Hb values exceed 12 g/dL, temporarily w/hold dose until Hb values falls <12 g/dL. Resume dosing at <25% of previous dose & titrate to maintain the desired Hb values. SC Adult Patient w/ chemotherapy-induced anaemia Initially 150 IU/kg 3 times/wk. If Hb value has increased by at least 1 g/dL or reticulocyte count has increased ≥40,000 cells/µL above baseline after 4 wk, continue current dose. If Hb value has not increased by ≥1 g/dL & reticulocyte count has not increased by ≥40,000 cells/µL above baseline after 4 wk, increase initial dose to 300 IU/kg 3 times/wk. Retain dose at 300 IU/kg 3 times/wk, if after an additional 4 wk Hb values has increased ≥1 g/dL or reticulocyte count has increased ≥40,000 cells/µL. Discontinue therapy, if after an additional 4 wk Hb value has increased <1 g/dL & reticulocyte count has increased <40,000 cells/µL above baseline. Perisurgery patient w/o autologous blood donation Recommended dose: 600 IU/kg given wkly for 3 wk, days 21, 14, & 7 prior to surgery & on the day of surgery. Patient scheduled for major elective orthopaedic surgery Recommended dose: 600 IU/kg given wkly for 3 wk, days 21, 14, & 7 prior to surgery & on the day of surgery. In case there is need to shorten the lead time before surgery to <3 wk, administer 300 IU/kg daily for 10 consecutive days prior & on the day of surgery & for 4 days immediately thereafter.

Hypersensitivity. Patients who develop pure red cell aplasia (PRCA) following treatment w/ any erythropoietin. Uncontrolled HTN. Contraindications associated w/ autologous blood predonation programmes. Severe coronary, peripheral arterial, carotid or cerebrovascular disease, recent MI or CVA in patients scheduled for major elective orthopaedic surgery & not participating in an autologous blood pre-donation programme. Patients who cannot receive adequate antithrombotic prophylaxis. Patients w/ MI or stroke in the mth preceding treatment, unstable angina pectoris, increased risk of DVT (eg, history of venous thromboembolic disease).

Closely monitor & control BP prior to initiation of treatment. Initiate or increase anti-hypertensive treatment during therapy in the presence of untreated, inadequately treated, or poorly controllable HTN; discontinue treatment if BP cannot be controlled. Hypertensive crisis w/ encephalopathy & seizures may occur in patients w/ previously normal or low BP; immediate & intensive medical care is required. Pay particular attention to sudden stabbing migraine-like headaches. Patients w/ epilepsy, history of seizures, or medical conditions associated w/ predisposition to seizure activity eg, CNS infections & brain metastases; underlying haematological diseases (eg, haemolytic anaemia, sickle cell anaemia, thalassemia, porphyria). Increased risk of thrombotic vascular events eg, venous & arterial thromboses & embolism (eg, DVT, pulmonary emboli, retinal thrombosis & MI). Cerebrovascular accidents (eg, cerebral infarction & haemorrhage, & transient ischaemic attacks). Closely monitor Hb levels due to potential increased risk of thromboembolic event & fatal outcomes when Hb levels are treated above the conc range. Moderate dose-dependent rise in platelet count; thrombocythaemia above the normal range. Regularly monitor platelet count during the 1st 8 wk of therapy. Evaluate & treat all other causes of anaemia (Fe, folate or vit B₁₂ deficiency, Al-intoxication, infection or inflammation, blood loss, haemolysis & bone marrow fibrosis of any origin) prior to initiating therapy w/ Epoetin-α. Immediately discontinue use if anti-erythropoietin, Ab-mediated PRCA is suspected. Measure Hb levels on a regular basis until stable & periodically thereafter in chronic renal failure & cancer patients. Assure adequate Fe stores or supplementation. Consider & evaluate other etiologies including Fe deficiency anemia if HIV-infected patients fail to respond or maintain a response to Epoetin-α. Routine vol replacement in surgery patients in autologous predonation programmes. Not to be used in perisurgery patients w/ baseline Hb >13 g/dL (8.1 mmol/L). Increased risk of HTN during initial phase of treatment may affect ability to drive or operate machinery. Monitor serum electrolytes in patients w/ chronic renal impairment. Chronic hepatic impairment. Increased erythropoiesis in patients w/ hepatic impairment due to decreased metabolism. Not recommended in pregnant & lactating surgical patients in an autologous blood predonation programme. Childn. Elderly.

Dose-dependent increase in BP or aggravation of existing HTN. Diarrhea, nausea, headache, flu-like illness (eg, joint pains, myalgia, dizziness & tiredness), pyrexia, rash, vomiting, DVT, pulmonary embolism, seizures.

May affect therapeutic response w/ drugs that can affect erythropoiesis. Potential interaction w/ cyclosporin.

Haematopoietic Agents

B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.

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