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The maximum amount of darbepoetin alfa that can be safely administered in single or multiple doses has not been determined. Doses over 3.0 μg/kg/week for up to 28 weeks have been administered to CRF patients without any direct toxic effects of darbepoetin alfa itself. Doses up to 8.0 μg/kg/week and 15.0 μg/kg/3 weeks have been safely administered to cancer patients for up to 22 weeks.
Darbepoetin alfa can result in polycythaemia if the haemoglobin is not carefully monitored and the dose appropriately adjusted. Cases of severe hypertension have been observed following overdose with darbepoetin alfa. If the suggested haemoglobin target range is exceeded, NESP should be reduced or temporarily withheld until the haemoglobin returns to the suggested target range. If withheld, NESP therapy may then be resumed using a lower dose (see DOSAGE & ADMINISTRATION). If clinically indicated, phlebotomy may be performed.
