Basic Information
EPREX 10000 PREFILLED SYRINGES 10000 iu/ml
INJECTION
Regulatory Information
SIN08486P
December 21, 1995
Prescription Only
Therapeutic
SUBCUTANEOUS
August 10, 2023
June 4, 2025
XB03XA01
Company Information
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Active Ingredients
Strength: 10000 iu/ml
Detailed Information
Contraindications
**Contraindications** Patients who develop antibody-mediated Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive EPREX® or any other erythropoietin (see _Warnings and Precautions, Pure Red Cell Aplasia_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Subcutaneous route of administration in chronic renal failure patients including end stage renal disease patients. Uncontrolled hypertension. Hypersensitivity to the active substance or to any of the excipients. All contraindications associated with autologous blood predonation programs should be respected in patients being supplemented with EPREX®. The use of EPREX® in patients scheduled for major elective orthopedic surgery and not participating in an autologous blood predonation program is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident. Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Indication Information
**Indications** EPREX® is indicated for the treatment of anemia associated with chronic renal failure in pediatric and adult patients on hemodialysis and peritoneal dialysis. EPREX® is indicated for the treatment of severe anemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. EPREX® is indicated for the treatment of anemia and reduction of transfusion requirements in adult cancer patients receiving chemotherapy. EPREX® is indicated for the treatment of anemia in adult HIV-infected patients being treated with zidovudine having endogenous erythropoietin levels ≤500 milliunits/mL. EPREX® is indicated in adults to facilitate autologous blood collection within a predeposit program and decrease the risk of receiving allogeneic blood transfusions in patients with moderate anemia (hematocrits of 33–39%, hemoglobin of 10–13 g/dL, \[6.2–8.1 mmol/L\], no iron deficiency), who are scheduled for major elective surgery and are expected to require more blood than that which can be obtained through autologous blood collection techniques in the absence of EPREX®. Treatment should only be given to patients if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). EPREX® is indicated to augment erythropoiesis in the perisurgical period in order to reduce allogeneic blood transfusions and correct postoperative anemia in adult non-iron deficient patients undergoing major elective orthopedic surgery. Use should be restricted to patients with moderate anemia ( _eg_ Hb 10–13 g/dL) who do not have an autologous predonation program available and with expected moderate blood loss (900 to 1800 mL). EPREX® is indicated for the treatment of anemia (hemoglobin concentration of ≤10 g/dL) in adults with low- or intermediate-1-risk myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 milliunits/mL).