Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Darbepoetin

Generic name
Darbepoetin
Brand name
ATC Code
B03XA02

Pharmacokinetics in children

Darbepoetin has a longer T½ compared to erythropoietin: administer once weekly.

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Anaemia in terminal renal insufficiency
  • Intravenous
    • 1 month up to 18 years
      [2]
      • Corrective phase 0.45 microg./kg/week in 1 dose Increase/decrease as necessary by 25% every 4 weeks. Maintenance dose:    Increase/decrease the dose by 25% every 2 weeks if necessary depending on the effect.

        In the maintenance phase, lower the dosing frequency to once every 2 weeks (or once every month for patients aged ≥11 years who are not undergoing dialysis) if necessary. Before lowering the frequency, first give a dose that is equal to twice the previous dose.  .
        • Haemoglobin target value between 10 g/dl (6.2 mmol/l) and 12 g/dl (7.5 mmol/l). Measure Hb once every 1-2 weeks until stable values have been achieved.
        • Children aged < 6 years might need a higher dose.
        • Conversion factor when switching from erythropoietin to darbepoetin: darbepoetin dose in micrograms = dose of erythropoietin in IU divided by 240.
  • Subcutaneous
    • 1 month up to 18 years
      [2]
      • Corrective phase 0.45 microg./kg/week in 1 dose Alternative for patients who don't have a central venous cathether or are not undergoing dialysis: 0.75 mcg/kg/dose once every 2 weeks.
        Increase/decrease as necessary by 25% every 4 weeks. Maintenance dose: Increase/decrease the dose by 25% every 2 weeks if necessary depending on the effect. In the maintenance phase, lower the dosing frequency to once every 2 weeks (or once every month for patients aged ≥11 years who are not undergoing dialysis) if necessary. Before lowering the frequency, first give a dose that is equal to twice the previous dose..
        • Haemoglobin target value between 10 g/dl (6.2 mmol/l) and 12 g/dl (7.5 mmol/l). Measure Hb once every 1-2 weeks until stable values have been achieved.
        • Children aged < 6 years might need a higher dose.
        • Conversion factor when switching from erythropoietin to darbepoetin: darbepoetin dose in micrograms = dose of erythropoietin in IU divided by 240.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The side effect profile in children with CKI does not differ from adults. (SmPC Aranesp)

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In renal insufficiency, the iron reserves have to be sufficient before starting the treatment. Iron supplements should be given during treatment.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Other antianemic preparations
B03XA01
B03XA01

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Amgen Europe BV, SmPC Aranesp (EU/1/01/185/001-111) Rev 45; 11/11/2022, www.ema.europa.eu

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Changes

Changes