Anaemia associated with chronic renal failure (CRF)

Active Ingredient: Epoetin zeta

Indication for Epoetin zeta

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Epoetin zeta is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in children aged 1 to 18 years on haemodialysis.

For this indication, competent medicine agencies globally authorize below treatments:

25-75 IU/kg once every 2 days

Route of admnistration

Intravenous

Defined daily dose

25 - 75 [iU] per kg of body weight

Dosage regimen

From 25 To 75 [iU] per kg of body weight once every 2 day(s)

Detailed description

Treatment of symptomatic anaemia in chronic renal failure patients on haemodialysis

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.

In paediatric patients the recommended haemoglobin concentration range is between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L). Epoetin zeta should be administered in order to increase haemoglobin to not greater than 11 g/dL (6.8 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.

Patients should be monitored closely to ensure that the lowest approved dose of epoetin zeta is used to provide adequate control of anaemia and of the symptoms of anaemia.

Treatment with epoetin zeta is divided into two stages – correction and maintenance phase.

In paediatric patients on haemodialysis where intravenous access is readily available, administration by the intravenous route is preferable.

Correction phase

The starting dose is 50 IU/kg intravenously, 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 of between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L) is achieved (this should be done in steps of at least four weeks).

Maintenance phase

Appropriate adjustment of the dose should be made in order to maintain haemoglobin levels within the desired concentration range between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L).

Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults. The following maintenance doses were observed in clinical trials after 6 months of treatment.

 Dose (IU/kg given 3 times per week)
Weight (kg) MedianUsual maintenance dose
<1010075-150
10-307560-150
>303330-100

Paediatric patients with very low initial haemoglobin (<6.8 g/dL or <4.25 mmol/L) may require higher maintenance doses than patients whose initial haemoglobin is higher (>6.8 g/dL or >4.25 mmol/L).

Dosage considerations

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.

Active ingredient

Epoetin zeta

Epoetin zeta is a recombinant human erythropoietin. Erythropoietin (EPO) is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of red blood cell (RBC) production. The 2 are indistinguishable on the basis of functional assays.

Read more about Epoetin zeta

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