EPREX 2,000 IU/ml solution for injection in pre-filled syringe
Epoetin alfa 2,000 IU/ml (16.8 micrograms per ml), produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology
A pre-filled syringe of 0.5 ml contains 1,000 IU (8.4 micrograms) of epoetin alfa.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium free.”
For the full list of excipients, see section 6.1.
Solution for injection in pre-filled syringe.
Clear, colourless solution.
EPREX is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
• in adults and paediatrics aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis.
• in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients.
EPREX is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.
EPREX is indicated in adults in a predonation programme to increase the yield of autologous blood. Treatment should only be given to patients with moderate anaemia (haemoglobin concentration range between 10 to 13 g/dl [6.2 to 8.1 mmol/l], no iron deficiency) 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 for non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1,800 ml).
Posology
All other causes of anaemia (iron, folate or Vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be eva luated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose. In order to ensure optimum response to epoetin alfa, adequate iron stores should be assured and iron supplementation should be administered if necessary (see section 4.4).
Treatment of symptomatic anaemia in adult chronic renal failure patients
Anaemia symptoms and sequelae may vary with age, gender, and co-morbid medical conditions; a physician's eva luation of the individual patient's clinical course and condition is necessary.
The recommended desired haemoglobin concentration range is between 10 g/dl to 12 g/dl (6.2 to 7.5 mmol/l). EPREX should be administered in order to increase haemoglobin to not greater than 12 g/dl (7.5 mmol/l). A rise in haemoglobin of greater than 2 g/dl (1.25 mmol/l) over a four week period should be avoided. If it occurs, appropriate dose adjustment should be made as provided.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin concentration range may be observed. Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin concentration range of 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).
A sustained haemoglobin level of greater than 12 g/dl (7.5 mmol/l) should be avoided. If the haemoglobin is rising by more than 2 g/dl (1.25 mmol/l) per month, or if the sustained haemoglobin exceeds 12 g/dl (7.5 mmol/l) reduce the EPREX dose by 25%. If the haemoglobin exceeds 13 g/dl (8.1 mmol/l), discontinue therapy until it falls below 12 g/dl (7.5 mmol/l) and then reinstitute EPREX therapy at a dose 25% below the previous dose.
Patients should be monitored closely to ensure that the lowest approved effective dose of EPREX is used to provide adequate control of anaemia and of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dl (7.5 mmol/l).
Caution should be exercised with escalation of ESA doses in patients with chronic renal failure. In patients with a poor haemoglobin response to ESA, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
Treatment with EPREX is divided into two stages – correction and maintenance phase.
Adult haemodialysis patients
In patients on haemodialysis where intravenous access is readily available, administration by the intravenous route is preferable.
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 to 7.5 mmol/l) is achieved (this should be done in steps of at least four weeks).
Maintenance phase:
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 to 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 patients with renal insufficiency not yet undergoing dialysis
Where intravenous access is not readily available EPREX 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
