Adult haemodialysis patients:
In patients on haemodialysis, where intravenous access is readily available, the intravenous route of administration should be used for ERYSAA.
The treatment is divided into two stages: Correction phase: 50 IU/kg three times per week. When necessary, dose adjustments should be made in increments of 25 IU/kg three times per week at intervals of at least 4 weeks until the target haemoglobin concentration (10-12 g/dL) is achieved.
Maintenance phase: Adjust dosage in order to maintain haemoglobin values at the desired level: Hb between 10 and 12 g/dL. The maintenance dose should be individualised for each chronic renal failure patient. The recommended total weekly dose is between 75 and 300 IU/kg. Available data suggests that patients with a baseline haemoglobin (<6 g/L) may require higher maintenance doses than patients with a baseline haemoglobin (>8 g/L).
Paediatric Haemodialysis Patients:
The treatment is divided into two stages: Correction phase: 50 IU/kg three times per week by the intravenous route. When necessary, dose adjustments should be made in increments of 25 IU/kg three times per week at intervals of at least 4 weeks until the target haemoglobin concentration (9.5-11 g/dL) is achieved.
Maintenance phase: Adjust dosage in order to maintain haemoglobin values at the desired level: Hb between 9.5 - 11 g/dl. Generally, children less than 30 kg require higher maintenance doses than children over 30 kg and adults. For example, the following maintenance doses were observed in clinical trials after 6 months of treatment. (See Table 1.)
Click on icon to see table/diagram/image
Available data suggest that patients whose initial haemoglobin is very low (haemoglobin <6.8 g/dL) may require higher maintenance doses than patients whose initial haemoglobin is higher (haemoglobin 6.8 g/dL).
Adult surgery patients in an autologous predonation programme:
The intravenous route of administration should be used for ERYSAA. Epoetin alfa should be administered after the completion of each blood donation procedure. Iron status should be evaluated for all patients prior to treatment with Epoetin alfa. Iron deficiency, if present, should be corrected before allowing a patient to enroll in an autologous blood donation programme. In anemic patients, the cause of anaemia should be explored before starting therapy with Epoetin alfa. All patients being treated with Epoetin alfa should receive adequate iron supplementation (e.g. 200 mg oral elemental iron daily) throughout the course of Epoetin alfa treatment. In order to achieve high iron stores prior to starting Epoetin alfa therapy, iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous pre-deposit. Mildly anaemic patients (haematocrit of 33 to 39% and/or haemoglobin 10 to 13 g/dL), requiring predeposit of ≥ 4 units of blood, should be treated with Epoetin alfa at 600 IU/kg 2 times weekly for 3 weeks prior to surgery. For those patients who require a lesser degree of erythropoietin stimulation, a dose regimen of 150-300 IU/kg administered twice weekly has been shown to augment autologous pre-donation and to decrease the subsequent decline in haematocrit.
ROUTE OF ADMINISTRATION:
ERYSAA is preservative free sterile solution for single use only.
This medicinal product must not be administered by intravenous infusion, or mixed with other medicinal products.
This medicinal product is not approved for subcutaneous use.
Epoetin alfa should be administered over at least one to five minutes, depending on the total dose. A slower injection may be preferable in patients who react to the treatment with flu-like symptoms. In haemodialysis patients, a bolus injection may be given during dialysis via a suitable venous port in the dialysis line. Alternatively, at the completion of a haemodialysis session, the injection can be given via the fistula needle tubing, followed by 10 ml of isotonic saline to rinse the tubing and to ensure satisfactory injection of the product into the circulation. Epoetin alfa should not be administered by intravenous infusion or mixed with other drugs.
Special instruction for use:
The pre-filled syringe is ready for use. Each syringe should be used for a single injection only. Do not re-use syringe. Discard unused portion. ERYSAA must not be shaken or mixed with any other liquid. Shaking may denature the glycoprotein, rendering it inactive.
Do not use ERYSAA if: the blister sealing is broken or the blister is damaged in any way; the liquid is coloured or floating particles can be seen in it; any liquid has leaked out of the pre-filled syringe or condensation visible within the sealed blister; you know or think it may have been accidentally frozen.