Eprex

Eprex Dosage/Direction for Use

epoetin alfa

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Chronic Renal Failure (CRF) Patients: In patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients), administration by the intravenous route is preferable. Where intravenous access is not readily available (patients not yet undergoing dialysis and peritoneal dialysis patients), Epoetin alfa may be administered subcutaneously.
The haemoglobin concentration aimed for should be between 10 to 12 g/dL (6.2-7.5 mmol/l) in adults and 9.5 to 11 g/dL (5.9-6.8 mmol/l) in children.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the haemoglobin concentration range (see Precautions).
When changing the route of administration, the same dose should be used initially and then titrated to keep haemoglobin in the haemoglobin concentration range.
In the correction phase, the dose of Epoetin alfa should be increased if the haemoglobin does not increase at least 1 g/dL (0.62 mmol/l) per month.
A clinically significant increase in haemoglobin is usually not observed in less than 2 weeks and may require up to 6-10 weeks in some patients.
When the haemoglobin concentration is within range, the dose should be decreased by 25 IU/kg/dose in order to avoid exceeding the haemoglobin concentration range. Dose should be reduced when haemoglobin approaches 12 g/dL.
Dose reductions may be made by omitting one of the weekly doses or by decreasing the amount of each dose.
Adult Haemodialysis Patients: In patients on haemodialysis, where intravenous access is readily available, administration by the intravenous route is preferable. 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 haemoglobin concentration range [10-12 g/dL (6.2-7.5 mmol/l)] is achieved.
Maintenance Phase: Adjust dosage in order to maintain haemoglobin values at the desired level: Hb between 10 and 12 g/dL (6.2-7.5 mmol/l).
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/dL or <3.7 mmol/l may require higher maintenance doses than patients with a baseline haemoglobin >8 g/dL or >5 mmol/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 haemoglobin concentration range (9.5-11 g/dL [5.9-6.8 mmol/l]) is achieved.
Maintenance Phase: Appropriate adjustment of the dose should be made in order to maintain the haemoglobin concentration within the desired range between 9.5 g/dl to 11 g/dl (5.9 to 6.8 mmol/l).
Generally, children under 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 5).

Click on icon to see table/diagram/image

Available data suggest that patients whose initial haemoglobin is very low [haemoglobin <6.8 g/dL (4.2 mmol/l)] may require higher maintenance doses than patients whose initial haemoglobin is higher [haemoglobin >6.8 g/dL (4.2 mmol/l)].
Adult Peritoneal Dialysis Patients: In peritoneal dialysis patients, where intravenous access is not readily available, Epoetin alfa may be administered subcutaneously.
The treatment is divided into two stages: Correction Phase: 50 IU/kg twice per week.
When necessary, dose adjustments should be made in increments of 25 IU/kg twice per week at intervals of at least 4 weeks until the haemoglobin concentration range [10-12 g/dL (6.2-7.5 mmol/l)] is achieved.
Maintenance Phase: The usual dose to maintain the haemoglobin concentration range [10-12 g/dL (6.2 7.5 mmol/l)] is between 25 and 50 IU/kg twice per week in two equal injections.
Paediatric Peritoneal Dialysis Patients: The treatment is divided into two stages: Correction Phase: 50 IU/kg three times per week by the intravenous or subcutaneous 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 haemoglobin concentration range [9.5-11 g/dL (5.90-6.83 mmol/l)] is achieved.
Maintenance Phase: Generally, children <30 kg require higher maintenance doses than children >30 kg and adults. For example, the following maintenance doses were observed in clinical trials after 6 months of treatment (see Table 5).
Available data suggest that patients with an initial haemoglobin [<6.8 g/dL (4.2 mmol/l)] may require higher maintenance doses than patients with an initial haemoglobin <6.8 g/dL (4.2 mmol/l).
Adult Predialysis Patients (Adult Patients With End Stage Renal Insufficiency): In patients with renal insufficiency not yet undergoing dialysis, where intravenous access is not readily available, Epoetin alfa may be administered subcutaneously.
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 haemoglobin concentration range [10-12 g/dL (6.2-7.5 mmol/l)] is achieved.
Maintenance Phase: The usual dose to maintain the haemoglobin concentration range is between 17 and 33 IU/kg three times per week. During the maintenance phase, EPREX can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Appropriate adjustment of dose and dose intervals should be made in order to maintain haemoglobin values at the desired level: Hb between 10 and 12 g/dl (6.2-7.5 mmol/l). Extending dose intervals may require an increase in dose.
The maximum dosage should not exceed 150 IU/kg 3 times per week, 240 IU/kg (up to a maximum of 20,000 IU) once weekly, or 480 IU/kg (up to a maximum of 40,000 IU) once every 2 weeks.
Cancer Patients: Adult Cancer Patients: The subcutaneous route of administration should be used.
The haemoglobin concentration range should be 10 to 12 g/dL (7.5 mmol/l) in men and women and it should not be exceeded.
Epoetin alfa therapy should continue until one month after the end of chemotherapy. However, the need to continue Epoetin alfa therapy should be re-evaluated periodically.
The initial dose for the treatment of anaemia should be 150 IU/kg 3 times per week.
Alternatively, Epoetin alfa can be administered at an initial dose of 40,000 IU subcutaneously once weekly.
If after 4 weeks of treatment at the initial dose, the haemoglobin has increased by at least 1 g/dL (0.6 mmol/L) (or the reticulocyte count has increased ≥40,000 cells/μl above baseline) the dose should remain unchanged.
If after 4 weeks of treatment at the initial dose, the haemoglobin has not increased by ≥1 g/dL (0.6 mmol/l) (and the reticulocyte count has not increased by ≥40,000 cells/μl above baseline), in the absence of red blood cell transfusion, the dose should be increased to 300 IU/kg 3 times per week or 60,000 IU weekly.
If after 4 weeks of additional therapy with 300 IU/kg 3 times per week or 60,000 IU weekly, the haemoglobin has increased ≥1 g/dL (≥0.6 mmol/l), (or the reticulocyte count has increased ≥40,000 cells/μl) the dose should remain unchanged.
If after 4 weeks of additional therapy with 300 IU/kg three times per week or 60,000 IU per week, the haemoglobin has increased <1 g/dL (0.6 mmol/l) (and the reticulocyte count has increased <40,000 cells/μl above baseline), response is unlikely and treatment should be discontinued.
The recommended dosing regimen is described in the following diagram: See Figure.

Click on icon to see table/diagram/image

A rate of rise in haemoglobin of greater than 1 g/dL (0.6 mmol/L) per 2 week or 2 g/dL (1.25 mmol/L) per month or haemoglobin levels of >12 g/dL (>8.1 mmol/L) should be avoided. If the haemoglobin is rising by more than 1 g/dL (0.6 mmol/l) per two week or 2 g/dL (1.25 mmol/L) per month or haemoglobin is approaching 12 g/dL (7.5 mmol/l), reduce the Epoetin alfa dose by about 25-50% depending upon the rate of rise of haemoglobin. If the haemoglobin exceeds 12 g/dL (7.5 mmol/l), withhold therapy until it falls below 12 g/dL (7.5 mmol/l) and then reinitiate Epoetin alfa therapy at a dose 25% below the previous dose.
Paediatric Cancer Patients: Published literature has reported the use in paediatric cancer patients between the ages 6 months to 18 years who were treated with 25 to 300 IU/kg of Epoetin alfa by subcutaneous or intravenous injection, three to seven times per week that resulted in an increase in haemoglobin and a decrease in transfusion requirements.
Zidovudine Treated HIV-Infected Patients: Adult Zidovudine Treated HIV-Infected Patients: Prior to beginning Epoetin alfa, it is recommended that the endogenous serum erythropoietin level be determined prior to transfusion. Available data suggests that patients with endogenous serum erythropoietin levels > 500 mU/ml are unlikely to respond to therapy with Epoetin alfa.
The treatment is divided into two stages: Correction Phase: 100 IU/kg three times per week by the subcutaneous or intravenous route for 8 weeks.
If the response is not satisfactory (ie, reduced transfusion requirements or increased haemoglobin) after 8 weeks of therapy, the dose of Epoetin alfa can be increased. Dose increases should be made in increments of 50 to 100 IU/kg three times per week at intervals of at least 4 weeks. If patients have not responded satisfactorily to an Epoetin alfa dose of 300 IU/kg three times per week, it is unlikely that they will respond to higher doses.
Maintenance Phase: After the desired response is attained, the dose should be titrated to maintain the haematocrit between 30-35%, based on factors such as variations in zidovudine dose and the presence of intercurrent infections or inflammatory episodes. If the haematocrit exceeds 40%, the dose should be discontinued until the haematocrit decreases to 36%. When treatment is resumed, the dose should be reduced by 25% and then titrated to maintain the desired haematocrit.
In zidovudine-treated HIV-infected patients the haemoglobin concentration should not exceed 12 g/dL (7.5 mmol/l).
Adult Surgery Patients in an Autologous Pre Donation Programme: The intravenous route of administration should be used. Epoetin alfa should be administered after the completion of each blood donation procedure.
Mildly anaemic patients (haematocrit of 33 to 39% and/or haemoglobin 10 to 13 g/dL (6.2-8.1 mmol/l) 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 erythropoietic 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.
Adult Perisurgery Patients (Without Autologous Blood Donation): The subcutaneous route of administration should be used.
The recommended dose regimen is 600 IU/kg of Epoetin alfa given weekly for three weeks (days -21, -14 and -7) prior to surgery and on the day of surgery.
In cases where there is a medical need to reduce the time before surgery to less than three weeks, the recommended dose regimen is 300 IU/kg for 10 consecutive days before surgery, on the day of surgery and up to 4 days after surgery. 300 IU/kg/day is recommended for haemoglobin levels ≤13 g/dL (8.1 mmol/l). If the haemoglobin level reaches 15 g/dL, or higher, administration of Epoetin alfa should be stopped and further dose should not be given.
Myelodysplastic Syndrome Patients: Eprex epoetin alfa should not be initiated at hemoglobin levels ≥10 g/dl. Use of concomitant  G-CSF agent should be based on physician justification.
Starting Dose: Prior to beginning Eprex therapy, it is recommended that the endogenous serum erythropoietin level be determined.  Available evidence suggests that patients with endogenous serum erythropoietin levels ≤200 mU/mL are more likely to respond to Eprex therapy.
The recommended dosage regimen is 150 IU/kg subcutaneously daily, (or 40,000-80,000 IU weekly). Hemoglobin levels should not exceed 12 g/dl.
Dose Adjustment: After 6-8 week, if the hemoglobin level increase less than 1 g/dl from baseline, increasing dose should be considered (60,000-80,000 IU/Weeks) if the starting dose was lower than 60,000 IU/week.  
If  hemoglobin >12 g/dl, withhold the dose and then restart at 25% below the previous dose. Discontinue therapy if there is no response after four months treatment at the higher dose (80,000 IU weekly) or discontinue therapy at disease progression.
Administration: Epoetin alfa may be administered by intravenous or subcutaneous injection.
As for any parenterally administered drug, the injection solution should be inspected for particles and discolouration prior to administration. Do not shake, shaking may denature the glycoprotein, rendering it inactive.
Epoetin alfa in single use vials and syringes contains no preservatives. Do not re-enter vial or re-use syringe. Discard unused portion.
Intravenous Injection: 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.
Subcutaneous Injection: The maximum volume per injection site should be 1 ml. In case of larger volumes, more than one injection site should be used.
The injections should be given in the limbs or the anterior abdominal wall.
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