Darboren

Darbepoetin alfa is used for symptomatic anaemia in adults and children with chronic renal failure. The symptoms and effects of anaemia may vary with age, gender and the overall burden of disease. The medicine is given either subcutaneously or intravenously, to bring haemoglobin up to no more than 12 g/dl (7.5 mmol/l). For patients who are not on hemodialysis, the subcutaneous route is preferable because it avoids puncturing peripheral veins. Treatment has two stages, a correction phase and a maintenance phase, and the guidance for adults and children is given separately.

For adults with chronic renal failure, the correction phase starts with 0.45 µg/kg body weight, given subcutaneously or intravenously as a single injection once weekly. Patients not on dialysis can start instead with a single subcutaneous injection of 0.75 µg/kg once every two weeks, or 1.5 µg/kg once monthly.

In the maintenance phase, dialysis patients may carry on with a single injection once weekly or once every two weeks. If a dialysis patient moves from once weekly to once every other week dosing, the first dose should be equal to twice the previous once weekly dose. Patients not on dialysis may continue once weekly, once every two weeks or once monthly. When a patient on once every two weeks has reached the target haemoglobin, the injection may then be given subcutaneously once monthly, starting at twice the previous once every two week dose.

For children with chronic renal failure, treatment under 1 year of age has not been studied in randomized clinical trials. In the correction phase for those ≥1 year of age, the starting dose is 0.45 µg/kg body weight, given subcutaneously or intravenously as a single injection once weekly. A child not on dialysis can alternatively start with 0.75 µg/kg as a single subcutaneous injection once every two weeks.

During maintenance, children ≥1 year of age may continue with a single injection once weekly or once every two weeks. Those <6 years of age may need higher doses to hold their haemoglobin than older children. Dialysis patients who change from once weekly to once every other week dosing should first receive twice the previous once weekly dose. Children ≥11 years of age who are not on dialysis and have reached the target haemoglobin on once every two week dosing may be given the medicine subcutaneously once monthly, starting at twice the previous once every two week dose.

For symptomatic chemotherapy-induced anaemia in cancer patients, darbepoetin alfa should be given by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl (6.2 mmol/l)), to bring haemoglobin up to no more than 12 g/dl (7.5 mmol/l). The recommended starting dose is 500 µg (6.75 µg/kg) once every three weeks, or 2.25 µg/kg body weight if you give it once weekly. If the patient's clinical response (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective.