Active Ingredient: Epoetin zeta
Epoetin zeta is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/mL).
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
450 - 450 [iU] per kg of body weight
From 450 To 450 [iU] per kg of body weight once every 7 day(s)
Epoetin zeta should be administered to patients with symptomatic anaemia (e.g. haemoglobin concentration ≤10 g/dL (6.2 mmol/L)).
The recommended starting dose is epoetin zeta 450 IU/kg (maximum total dose is 40 000 IU) administered subcutaneously once every week, with not less than 5 days between doses.
Appropriate dose adjustments should be made to maintain haemoglobin concentrations within the target range of 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L). It is recommended that initial erythroid response be assessed 8 to 12 weeks following initiation of treatment. Dose increases and decreases should be done one dosing step at a time (see diagram below). A haemoglobin concentration of greater than 12 g/dL (7.5 mmol/L) should be avoided.
Dose should not be increased over the maximum of 1 050 IU/kg (total dose 80 000 IU) per week. If the patient loses response or haemoglobin concentration drops by ≥1 g/dL upon dose reduction the dose should be increased by one dosing step. A minimum of 4 weeks should elapse between dose increases.
Epoetin zeta should be withheld when the haemoglobin concentration exceeds 12 g/dL (7.5 mmol/L). Once the haemoglobin level is <11 g/dL the dose can be restarted on the same dosing step or one dosing step down based on physician judgement. Decreasing the dose by one dosing step should be considered if there is a rapid increase in haemoglobin (>2 g/dL over 4 weeks).
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.
The injections should be given in the limbs or the anterior abdominal wall.
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