Active Ingredient: Epoetin zeta
Epoetin zeta is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
25 - 75 [iU] per kg of body weight
From 25 To 75 [iU] per kg of body weight once every 2 day(s)
All other causes of anaemia (iron, folate or Vitamin B 12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin zeta, and when deciding to increase the dose. In order to ensure optimum response to epoetin zeta, adequate iron stores should be assured and iron supplementation should be administered if necessary.
Anaemia symptoms and sequelae may vary with age, gender and co-morbid medical conditions; a physician’s evaluation 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). Epoetin zeta 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 Retracrit 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 epoetin zeta therapy at a dose 25% below the previous dose.
Patients should be monitored closely to ensure that the lowest approved effective dose of epoetin zeta 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 erythropoiesis-stimulating agent (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.
Treatment with epoetin zeta is divided into two stages – correction and maintenance phase.
In patients on haemodialysis where intravenous access is readily available, administration by the intravenous route is preferable.
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).
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).
Where intravenous access is not readily available epoetin zeta may be administered subcutaneously.
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).
During the maintenance phase, epoetin zeta 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: haemoglobin between 10 g/dL to 12 g/dL (6.2 to 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.
Where intravenous access is not readily available epoetin zeta may be administered subcutaneously.
The starting dose is 50 IU/kg, 2 times per week.
The recommended maintenance dose is between 25 IU/kg and 50 IU/kg, 2 times per week in 2 equal injections.
Appropriate adjustment of the dose should be made in order to maintain haemoglobin values at the desired level between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Administer over at least one to five minutes, depending on the total dose. In haemodialysed patients, a bolus injection may be given during the dialysis session through a suitable venous port in the dialysis line. Alternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 mL of isotonic saline to rinse the tubing and ensure satisfactory injection of the product into the circulation.
Subcutaneous
25 - 75 [iU] per kg of body weight
From 25 To 75 [iU] per kg of body weight once every 2 day(s)
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 evaluated and treated prior to initiating therapy with epoetin zeta, and when deciding to increase the dose. In order to ensure optimum response to epoetin zeta, adequate iron stores should be assured and iron supplementation should be administered if necessary.
Anaemia symptoms and sequelae may vary with age, gender and co-morbid medical conditions; a physician’s evaluation 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). Epoetin zeta 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 Retracrit 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 epoetin zeta therapy at a dose 25% below the previous dose.
Patients should be monitored closely to ensure that the lowest approved effective dose of epoetin zeta 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 erythropoiesis-stimulating agent (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.
Treatment with epoetin zeta is divided into two stages – correction and maintenance phase.
In patients on haemodialysis where intravenous access is readily available, administration by the intravenous route is preferable.
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).
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).
Where intravenous access is not readily available epoetin zeta may be administered subcutaneously.
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).
During the maintenance phase, epoetin zeta 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: haemoglobin between 10 g/dL to 12 g/dL (6.2 to 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.
Where intravenous access is not readily available epoetin zeta may be administered subcutaneously.
The starting dose is 50 IU/kg, 2 times per week.
The recommended maintenance dose is between 25 IU/kg and 50 IU/kg, 2 times per week in 2 equal injections.
Appropriate adjustment of the dose should be made in order to maintain haemoglobin values at the desired level between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
The injections should be given in the limbs or the anterior abdominal wall.
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