Eprex

Eprex

epoetin alfa

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Concise Prescribing Info
Contents
Epoetin α
Indications/Uses
Anaemia associated w/ chronic renal failure in paed & adult on haemodialysis & peritoneal dialysis; severe anaemia of renal origin accompanied by clinical symptoms in adult w/ renal insufficiency and not yet undergoing dialysis. Anaemia & reduction of transfusion requirements in adult cancer patients (w/ non-myeloid malignancies) receiving chemotherapy; or in zidovudine-treated HIV patient. To facilitate autologous blood collection w/in a predeposit program & decrease the risk of receiving allogeneic blood transfusions (w/ moderate anemia) in patients scheduled for major elective surgery. Augment erythropoiesis in the perisurgical period in order to reduce allogeneic blood transfusions & correct post-op anemia in adult non-iron deficient patients undergoing major elective orthopaedic surgery. Anaemia in patients w/ low or intermediate 1-risk myelodysplastic syndrome (MDS).
Dosage/Direction for Use
Target Hb level should be determined. Haemodialysis Correction phase: Adult & childn 50 IU/kg by IV 3x wkly. When necessary, dose adjustments should be made in increments of 25 IU/kg 3x wkly at intervals of 4 wk until Hb conc range [10-12 g/dL (6.2-7.5 mmol/L) for adults, 9.5-11 g/dL (5.9-6.8 mmol/L) for childn] is achieved. Maintenance: Adult 75-300 IU/kg wkly. Childn >30 kg 30-100 IU/kg, 10-30 kg 60-150 IU/kg, <10 kg 75-150 IU/kg. All doses to be given 3x wkly. Peritoneal dialysis Adult Correction phase: 50 IU/kg SC twice wkly. Childn Correction phase: 50 IU/kg by IV or SC 3x wkly. Maintenance: Adult 25-50 IU/kg twice wkly. Childn >30 kg 30-100 IU/kg, 10-30 kg 60-150 IU/kg, <10 kg 75-150 IU/kg. All doses to be given 3x wkly. Predialysis (w/ end-stage renal insufficiency) Adult Correction phase: 50 IU/kg by SC 3x wkly. Maintenance: 17-33 IU/kg 3x wkly. Max dose: 150 IU/kg 3x wkly, 240 IU/kg once wkly, 480 IU/kg once every 2 wk. Treatment of anaemia in cancer patient w/ chemotherapy Adult 150 IU/kg 3x wkly SC, alternatively epoetin α can be administered at an initial dose of 40,000 IU SC wkly. Target Hb conc: 10-12 g/dL (7.5 mmol/L) in men & women & should not be exceeded. If after 4 wk of treatment at the initial dose, the Hb has increased by at least 1 g/dL (0.6 mmol/L) or reticulocyte count has increased ≥40,000 cells/microL above baseline), dose should remain unchanged; in the abscence of RBC transfusion, the dose should be increased to 300 IU/kg 3x/wk or 60,000 IU wkly. If after 4 wk of additional therapy w/ 300 IU/kg 3x wkly or 60,000 IU wkly, the Hb has increased ≥1 g/dL (≥0.6 mmol/L), (or the reticulocyte count has increased ≥40,000 cells/microL) dose should remain unchanged. Zidovudine-treated HIV-infected patient (correction phase) 100 IU/kg IV/SC 3x wkly for 8 wk. If response is not satisfactory after 8 wk, dose can be increased. Dose increases should be made in increments of 50-100 IU/kg 3x wkly at intervals of at least 4 wk. Maintenance: Dose should be titrated to maintain haematocrit between 30-35%. Hb conc should not exceed 12 g/dL. Autologous blood donation for surgery Adult 600 IU/kg IV twice wkly for 3 wk prior to surgery. Patients who require a lesser degree of erythopoietic stimulation 150-300 IU/kg twice wkly. Perisurgery patient (w/o autologous blood donation) 600 IU/kg SC once wkly for 3 wk prior to surgery & on the day of surgery or 300 IU/kg/day SC for 10 days pre-op, on the day of op & for 4 days post-op. Myelodysplastic syndrome patients Determine endogenous serum erythropoietin levels prior to therapy. 150 IU/kg/day SC. Hb levels should no exceed 12 g/L
Contraindications
Hypersensitivity. Patients who developed antibody-mediated pure red cell aplasia (PRCA). Uncontrolled HTN. Patients scheduled for elective surgery w/o autologous blood predonation: Severe coronary, peripheral arterial, carotid & cerebrovascular disease including recent MI or CVA. Surgery patients that cannot receive adequate antithrombotic prophylaxis.
Special Precautions
Untreated, inadequately treated or poorly controllable HTN. Discontinue if BP cannot be controlled. Epilepsy, history of seizures or medical conditions associated w/ predisposition to seizure activity eg, CNS infections & brain metastases; chronic liver failure. Hepatic dysfunction. Thrombotic vascular events. Underlying haematologic disease (eg, haemolytic anaemia, sickle cell anaemia, thalassemia). Monitor platelet count during the first 8 wk of therapy. Evaluate patients w/ other causes of anaemia eg, Fe, folate or vit B12 deficiency, Al intoxication, infection or inflammation, blood loss, haemolysis & bone marrow fibrosis of any origin & treat prior to initial therapy. Porphyria. Ensure patient has adequate stored Fe. Monitor Hb & rate of increase, BP, platelet count & serum electrolytes. Dialysis prescription may need to be adjusted periodically. HIV-infected patients. Perisurgery patients w/ baseline Hb >13 g/dL (8.1 mmol/L). Renal impairment. Pregnancy & lactation.
Adverse Reactions
Diarrhoea, nausea, vomiting, pyrexia & headache. Influenza-like illness. Resp tract congestion (upper resp tract congestion, nasal congestion). Thrombotic vascular events. Hypersensitivity reactions including, rash (urticaria), anaphylactic reaction, & angioedema. Hypertensive crisis w/ encephalopathy & seizures. Sudden-stabbing migraine-like headaches.
Drug Interactions
Concomitant use w/ cyclosporin. Effects may be potentiated w/ ferrous sulphate.
MIMS Class
Haematopoietic Agents / Supportive Care Therapy
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
Eprex inj 40000 IU/mL
Packing/Price
1's
Form
Eprex pre-filled inj 10000 IU/mL
Packing/Price
1's
Form
Eprex pre-filled inj 2000 IU/0.5 mL
Packing/Price
(pre-filled syringe w/ needle guard (PROTECS)) 1's
Form
Eprex pre-filled inj 20000 IU/0.5 mL
Packing/Price
1's
Form
Eprex pre-filled inj 3000 IU/0.3 mL
Packing/Price
1's
Form
Eprex pre-filled inj 4000 IU/0.4 mL
Packing/Price
1's
Form
Eprex pre-filled inj 40000 IU/mL
Packing/Price
1's
Form
Eprex pre-filled inj 5000 IU/0.5 mL
Packing/Price
1's
Form
Eprex pre-filled inj 6000 IU/0.6 mL
Packing/Price
1's
Form
Eprex pre-filled inj 8000 IU/0.8 mL
Packing/Price
1's
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