Erythropoietine (epoetine zeta)

Generic name
Erythropoietine (epoetine zeta)
Brand name
ATC Code
B03XA01
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Erythropoietine (epoetine zeta)

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

A half-life of approximately 6.2 to 8.7 hours has been reported in pediatric subjects with chronic renal failure after multiple intravenous administration of erythropoietin. The pharmacokinetic profile of erythropoietins in children and adolescents appears to be similar to that in adults.

There are limited pharmacokinetic data in neonates. A study in 7 very low birth weight preterm neonates and in 10 healthy adults to whom erythropoietin was given intravenously suggested that the volume of distribution was about 1.5 to 2 times higher in the preterm neonates than in the healthy adults, and that clearance was about 3 times higher in the preterm neonates than in healthy adults.

(SmPC Retocrit)

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Anaemia due to chronic renal insufficiency with haemodialysis
  • Intravenous
    • 1 year up to 18 years

      • Start: 50 IU/kg/dose 3 times per week. Maintenance dose: Increase or decrease the(starting) dose if needed after every 4 weeks in increments of 25 IU/kg until the desired hemoglobin concentration is reached (between 6,8-7,5 mmol/l).

        Usually, children with body weight under 30 kg require a higher maintenance dose than children over 30 kg and adults.

      • In chronic renal insufficiency, intravenous administration is preferred in children with routine intravenous access (hemodialysis). During hemodialysis, administer as a bolus injection via an appropriate venous injection port in the dialysis line, or at the end of dialysis via the fistula needle. If intravenous access is not routinely available, epoetin zeta can be administered subcutaneously.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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 is similar to that of adults. 

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

No information available on specific warnings and precautions in children.

Interactions

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

OTHER ANTIANEMIC PREPARATIONS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Other antianemic preparations
B03XA02
B03XA01
B03XA01
B03XA03

References

  1. Pfizer Europe MA EEIG, SmPC Retacrit (EU/1/07/431) Rev 30, 14-12-2022, www.ema.europa.eu
  2. Kidney Disease: Improving Global Outcomes (KDIGO), Clinical practice guidelines: Anemia in Chronic Kidney Disease, 2012, 2 (4)

Changes

Therapeutic Drug Monitoring


Overdose