Erythropoiesis stimulating protein produced in Chinese hamster ovary cells by recombinant DNA technique.
A 165 amino acid protein differing from erythropoietin by having 5 N-linked oligosaccharide chains instead of 3 such chains and the additional carbohydrate chains increase the approximate molecular weight from 30-37,000 daltons.
For intravenous and subcutaneous administration.
Increased hemoglobin levels not generally seen until 2-6 weeks after initiation of treatment.
Following intravenous administration serum concentration time profiles are biphasic with a distribution half life of approximately 1.4 hours and a mean terminal half life of 21 hours.
Terminal half life approximately 3 fold longer than that of epoetin alfa when given intravenously.
In a study involving 4038 patients with diabetes, chronic kidney disease, and anemia were randomly assigned to darbepoetin to achieve a hemoglobin of approximately 13 g per deciliter compared to placebo and darbepoetin rescue when the hemoglobin was less than 9 g per deciliter: the use of darbepoetin for diabetic patients with chronic kidney disease and moderate anemia, who were not undergoing dialysis did not reduce death, or cardiovascular events, or renal events and was associated with an increased risk of stroke(Trial to Reduce Cardiovascular Events with Aranesp Therapy [TREAT}.
Testing darbepoetin against placebo for anemia mildly reduced fatige, and number of transfusions needed, but did not reduce risk of death or cardiovascular deaths and almost doubled risk of stroke (Pfeffer MA).
In a randomized double-blind trial assigning 2270 patients with systolic heart failure and mild to moderate anemia with hemoglobin levels 9-12 g/dL to receive either darbepoetin alfa or placebo: clinical outcomes were not improved (Swedberg K et al).