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

Interactions
PK
Renal impairment
References

Erythropoietin (epoetin beta)

Generic name
Erythropoietin (epoetin beta)
Brand name
ATC Code
B03XA01

Pharmacokinetics in children

No information

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

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Available formulations

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Dosages

Prevention of anemia in preterm neonates
  • Subcutaneous
    • Gestational age < 34 weeks and 750 up to 1500 g
      [4]
      • 250 IU/kg/dose 3x per week.
      • Duration of treatment:

        6 weeks

      • Give extra iron orally during full nutrition.
Anaemia in pre-terminal renal insufficiency
  • Subcutaneous
    • 1 month up to 18 years
      • Initial dose:
         50         IU/kg/week in 2 - 3 doses. Maintenance dose: Adjust the dosage depending on the Hb. Target Hb value: 11-12 g/dl (6,8-7,5 mmol/l), target haematocrit value: 0,35 l/l..
Anaemia in terminal renal insufficiency
  • Intraperitoneal
    • 1 month up to 18 years
      • Initial dose: 100 IU/kg/week in 2 - 3 doses. Maintenance dose: Adjust the dosage depending on the Hb. Target Hb value: 11-12 g/dl (6,8-7,5 mmol/l). Target haematocrit value: 0,35 l/l.
  • Intravenous
    • 1 month up to 18 years
      [4] [5]

      • Startdosering: 40 IE/KG/dose 3 times a  week.
        Maintenance dose: After 4 weeks dependent on Hb increase initial dose to 80 IE/kg/dose 3 times a week. If further dose increase is indicated based on Hb, increase dose every other month with dose increments of 20 IE/kg up to a maxium of 240 IE/kg 3 times a week. 80 IE/kg/dosis 3 keer per week untill correction of Hb value has been achieved. 

        After correction of HB has been achieved, decrease the dose to half of the last administered dose. Dose is further adjusted based on Hb.

        Target value Hb: 11-12 g/dl (6,8-7,5 mmol/l), target haematocrit value: 0,35 l/l.

      •  

         

         

  • Subcutaneous
    • 1 month up to 18 years
      [4]
      • Initial dose: 20 IU/kg/dose 3x per week.
      • Maintenance dose: Increase the dose if necessary every 4 weeks by 20 IU/kg to 20 - 240 IU/kg/dose 3x per week.

      • In maintenance phase, lower the dosage to half the last administered dose; then lower the dose further at intervals of 1-2 weeks to meet the individual need

        Target value Hb: 11-12 g/dl (6,8-7,5 mmol/l), target haematocrit: 0,35 l/l

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

Hypertension, convulsions, thrombosis of vascular access point, reversible neutropenia in premature infants.

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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 in children

Severe hypertension, epilepsy.

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.

In premature neonates, platelet count can increase slightly, especially in the first two weeks of life, so platelet count should be monitored regularly. In premature infants, the potential risk of erythropoietin triggering retinopathy could not be ruled out (weigh benefits and risks before use). (SmPC)

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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
B03XA02
B03XA01

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Heijden, van der AJ et al, Werkboek Kindernefrologie, VU Uitgeverij, 2002, 1e druk
  3. Berg van den, HB et al, Werkboek Kinderhematologie, VU Uitgeverij, 2001, 2e druk
  4. Roche Registration GmbH, SmPC NeoRecormon (EU/1/97/031) 22-08-2019, www.geneesmiddeleninformatiebank.nl
  5. KDIGO, Clinical practice guideline for anemia in chronic kidney disease, http://www.kidney-international.org, 2012, 2 (4) August (2)

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Changes

Changes