Active Ingredient: Darbepoetin alfa
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
0.45 - 0.45 ug per kg of body weight
From 0.45 To 0.45 ug per kg of body weight once every 7 day(s)
Treatment of paediatric patients younger than 1 year of age has not been studied.
For patients ≥11 years of age, the initial dose by subcutaneous or intravenous administration is 0.45 µg/kg body weight, as a single injection once weekly. Alternatively, in patients not on dialysis, an initial dose of 0.75 μg/kg may be administered subcutaneously as a single injection once every two weeks. If the increase in haemoglobin is inadequate (less than 1 g/dl (0.6 mmol/l) in four weeks) increase the dose by approximately 25%. Dose increases must not be made more frequently than once every four weeks.
If the rise in haemoglobin is greater than 2 g/dl (1.25 mmol/l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase. If the haemoglobin exceeds 12 g/dl (7.5 mmol/l), a dose reduction should be considered. If the haemoglobin continues to increase, the dose should be reduced by approximately 25%. If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
The haemoglobin should be measured every one or two weeks until it is stable. Thereafter the haemoglobin can be measured at longer intervals.
Correction of anaemia in paediatric patients with once monthly darbepoetin dosing frequency has not been studied.
For paediatric patients ≥11 years of age, in the maintenance phase, darbepoetin may continue to be administered as a single injection once weekly or once every two weeks. Dialysis patients converting from once weekly to once every other week dosing with darbepoetin should initially receive a dose equivalent to twice the previous once weekly dose.
In patients ≥11 years of age not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, darbepoetin may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Clinical data in paediatric patients has demonstrated that patients receiving r-HuEPO two or three times weekly may be converted to once weekly darbepoetin, and those receiving r-HuEPO once weekly may be converted to once every other week darbepoetin. The initial weekly paediatric dose of darbepoetin (µg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 240. The initial every other week dose of darbepoetin (μg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 240. Because of individual variability, titration to optimal therapeutic doses is expected for individual patients. When substituting darbepoetin for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Dosing should be titrated as necessary to maintain the haemoglobin target.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
If the rise in haemoglobin is greater than 2 g/dl (1.25 mmol/l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase. If the haemoglobin exceeds 12 g/dl (7.5 mmol/l), a dose reduction should be considered. If the haemoglobin continues to increase, the dose should be reduced by approximately 25%. If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
Patients starting dialysis during treatment with darbepoetin should be closely monitored for adequate control of their haemoglobin.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks. Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
Intravenous
0.45 - 0.45 ug per kg of body weight
From 0.45 To 0.45 ug per kg of body weight once every 7 day(s)
Treatment of paediatric patients younger than 1 year of age has not been studied.
For patients ≥11 years of age, the initial dose by subcutaneous or intravenous administration is 0.45 µg/kg body weight, as a single injection once weekly. Alternatively, in patients not on dialysis, an initial dose of 0.75 μg/kg may be administered subcutaneously as a single injection once every two weeks. If the increase in haemoglobin is inadequate (less than 1 g/dl (0.6 mmol/l) in four weeks) increase the dose by approximately 25%. Dose increases must not be made more frequently than once every four weeks.
If the rise in haemoglobin is greater than 2 g/dl (1.25 mmol/l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase. If the haemoglobin exceeds 12 g/dl (7.5 mmol/l), a dose reduction should be considered. If the haemoglobin continues to increase, the dose should be reduced by approximately 25%. If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
The haemoglobin should be measured every one or two weeks until it is stable. Thereafter the haemoglobin can be measured at longer intervals.
Correction of anaemia in paediatric patients with once monthly darbepoetin dosing frequency has not been studied.
For paediatric patients ≥11 years of age, in the maintenance phase, darbepoetin may continue to be administered as a single injection once weekly or once every two weeks. Dialysis patients converting from once weekly to once every other week dosing with darbepoetin should initially receive a dose equivalent to twice the previous once weekly dose.
In patients ≥11 years of age not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, darbepoetin may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Clinical data in paediatric patients has demonstrated that patients receiving r-HuEPO two or three times weekly may be converted to once weekly darbepoetin, and those receiving r-HuEPO once weekly may be converted to once every other week darbepoetin. The initial weekly paediatric dose of darbepoetin (µg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 240. The initial every other week dose of darbepoetin (μg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 240. Because of individual variability, titration to optimal therapeutic doses is expected for individual patients. When substituting darbepoetin for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Dosing should be titrated as necessary to maintain the haemoglobin target.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
If the rise in haemoglobin is greater than 2 g/dl (1.25 mmol/l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase. If the haemoglobin exceeds 12 g/dl (7.5 mmol/l), a dose reduction should be considered. If the haemoglobin continues to increase, the dose should be reduced by approximately 25%. If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
Patients starting dialysis during treatment with darbepoetin should be closely monitored for adequate control of their haemoglobin.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks. Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
Subcutaneous
0.75 - 0.75 ug per kg of body weight
From 0.75 To 0.75 ug per kg of body weight once every 14 day(s)
Treatment of paediatric patients younger than 1 year of age has not been studied.
For patients ≥11 years of age, the initial dose by subcutaneous or intravenous administration is 0.45 µg/kg body weight, as a single injection once weekly. Alternatively, in patients not on dialysis, an initial dose of 0.75 μg/kg may be administered subcutaneously as a single injection once every two weeks. If the increase in haemoglobin is inadequate (less than 1 g/dl (0.6 mmol/l) in four weeks) increase the dose by approximately 25%. Dose increases must not be made more frequently than once every four weeks.
If the rise in haemoglobin is greater than 2 g/dl (1.25 mmol/l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase. If the haemoglobin exceeds 12 g/dl (7.5 mmol/l), a dose reduction should be considered. If the haemoglobin continues to increase, the dose should be reduced by approximately 25%. If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
The haemoglobin should be measured every one or two weeks until it is stable. Thereafter the haemoglobin can be measured at longer intervals.
Correction of anaemia in paediatric patients with once monthly darbepoetin dosing frequency has not been studied.
For paediatric patients ≥11 years of age, in the maintenance phase, darbepoetin may continue to be administered as a single injection once weekly or once every two weeks. Dialysis patients converting from once weekly to once every other week dosing with darbepoetin should initially receive a dose equivalent to twice the previous once weekly dose.
In patients ≥11 years of age not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, darbepoetin may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Clinical data in paediatric patients has demonstrated that patients receiving r-HuEPO two or three times weekly may be converted to once weekly darbepoetin, and those receiving r-HuEPO once weekly may be converted to once every other week darbepoetin. The initial weekly paediatric dose of darbepoetin (µg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 240. The initial every other week dose of darbepoetin (μg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 240. Because of individual variability, titration to optimal therapeutic doses is expected for individual patients. When substituting darbepoetin for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Dosing should be titrated as necessary to maintain the haemoglobin target.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
If the rise in haemoglobin is greater than 2 g/dl (1.25 mmol/l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase. If the haemoglobin exceeds 12 g/dl (7.5 mmol/l), a dose reduction should be considered. If the haemoglobin continues to increase, the dose should be reduced by approximately 25%. If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
Patients starting dialysis during treatment with darbepoetin should be closely monitored for adequate control of their haemoglobin.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks. Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
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