Eprex

Eprex

epoetin alfa

Manufacturer:

Johnson & Johnson
Concise Prescribing Info
Contents
Epoetin α
Indications/Uses
Anaemia & reduction of transfusion requirements in adult cancer patients receiving chemotherapy. Anaemia associated w/ chronic renal failure in adult patients on haemodialysis & peritoneal dialysis; paed patients on haemodialysis. Severe anaemia of renal origin accompanied by clinical symptoms in adult patients w/ renal insufficiency not yet undergoing dialysis. Facilitates autologous blood collection w/in a predeposit programme & decrease risk of receiving allogeneic blood transfusions in patients w/ moderate anaemia 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 epoetinum α. Augments erythropoiesis in the presurgical period in order to reduce allogeneic blood transfusions & correct post-op anaemia in adult non-iron deficient patients undergoing major elective orthopaedic surgery. Anaemia in symptomatic HIV-infected patients being treated with AZT & who are transfusion-dependent.
Dosage/Direction for Use
IV Hemodialysis Adult Correction phase: 50 IU/kg 3 times wkly. Adjust dose in 25 IU/kg-increments 3 times wkly at ≥4-wk intervals. Maintenance phase: Individualized dosage. Recommended total wkly dose: 75-300 IU/kg. Childn Correction phase: 50 IU/kg 3 times wkly. Adjust dose in 25 IU/kg-increments 3 times wkly at ≥4-wk intervals. Maintenance phase: Body wt >30 kg 30-100 IU/kg 3 times wkly, 10-30 kg 60-150 IU/kg 3 times wkly, <10 kg 75-150 IU/kg 3 times wkly. SC Pre- & peritoneal dialysis Correction phase: 50 IU/kg 3 times wkly. Adjust dose in 25 IU/kg-increments 3 times wkly at ≥4-wk intervals. Maintenance phase: 17-33 IU/kg 3 times wkly. Max: 200 IU/kg 3 times wkly. Cancer patient Initially 150 IU/kg 3 times wkly. If Hb has not increased by ≥1 g/dL & reticulocyte count has not increased by ≥40,000 cells/mcL after 4 wk, increase dose to 300 IU/kg 3 times wkly. If Hb has increased <1 g/dL & reticulocyte count has increased <40,000 cells/mcL after 4 wk additional therapy, discontinue treatment. IV Surgery patient in an autologous pre-donation programme 600 IU/kg 2 times wkly for 3 wk prior to surgery. SC Adult perisurgery patient 600 IU/kg wkly for 3 wk prior to surgery & on the day of surgery.
Contraindications
Hypersensitivity. Pure Red Cell Aplasia (PRCA) following erythropoietin treatment. 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 predonation programme. Patients who cannot receive adequate antithrombotic prophylaxis. MI or stroke in the mth preceding treatment, unstable angina pectoris, history of venous thromboembolic disease in patients requiring Eprex to facilitate autologous blood collection.
Special Precautions
Closely monitor & control BP. Pay particular attention to sudden stabbing migraine-like headache. Discontinue therapy if anti-erythropoietin, Ab-mediated PRCA is suspected; BP cannot be controlled. Patients w/ epilepsy, history of seizures, or medical conditions associated w/ a predisposition to seizure activity eg, CNS infections & brain metastases; underlying haematologic diseases; porphyria; cancer. Increased incidence of thrombotic vascular events. Closely monitor Hb conc. Platelet count should be regularly monitored during 1st 8 wk of therapy. Other causes of anaemia should be evaluated & treated prior to initiation of therapy & before decision to increase dose. Discontinue if a severe cutaneous reaction eg, Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected. HIV-infected patients. Adult surgery patients in an autologous pre-donation programme & adult perisurgery patients w/o autologous blood donation. Not recommended in perisurgery patients w/ a baseline Hb of >13 g/dL. Chronic liver & renal failure. Pregnancy & lactation.
Adverse Reactions
Dose-dependent BP increase, diarrhoea, nausea, vomiting, pyrexia, headache, influenza-like illness, hypersensitivity reactions, hypertensive crisis w/ encephalopathy-like symptoms & seizures, thrombotic vascular events.
Drug Interactions
Drugs that decrease erythropoiesis may decrease response to Eprex. Monitor blood levels of cyclosporin. Potentiation of effects w/ haematinic agents.
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
Eprex inj 4000 IU/0.4 mL
Packing/Price
0.4 mL x 6 × 1's (Rp3,181,500/boks)
Form
Eprex inj 10000 IU/mL
Packing/Price
1 mL x 6 × 1's (Rp6,900,000/boks)
Form
Eprex inj 40,000 IU/mL
Packing/Price
1's (Rp2,090,909/boks)
Form
Eprex inj 2000 IU/0.5 mL
Packing/Price
0.5 mL x 6 × 1's (Rp1,606,500/boks)
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