Darbepoetin alfa

(Aranesp®)

Aranesp®

Drug updated on 11/1/2024

Dosage FormInjection (intravenous/subcutaneous; 25 mcg, 40 mcg, 60 mcg, 100 mcg, 200 mcg and 300 mcg); Injection (intravenous/subcutaneous; 10 mcg/0.4 mL, 25 mcg/0.42 mL, 40 mcg/0.4 mL, 60 mcg/0.3 mL, 100 mcg/0.5 mL, 150 mcg/0.3 mL, 200 mcg/0.4 mL, 300 mcg/0.6 mL, and 500 mcg/1 mL)
Drug ClassErythropoiesis-stimulating agents (ESA)
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis
  • Indicated for the treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Latest News

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Summary
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  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • In CKD (chronic kidney disease) patients, recombinant human EPO (rHuEPO) provided notable cognitive benefits, including improved neuropsychological test performance and positive electroencephalographic changes, supporting its role in enhancing brain function for this population.
  • HIF-PH inhibitors (HIF-PHIs) and ESAs (erythropoiesis-stimulating agents) demonstrated similar hemoglobin response rates, though Roxadustat was associated with a lower risk of RBC transfusion than rHuEPO, and HIF-PHIs overall were more effective in reducing hepcidin levels and increasing total iron-binding capacity (TIBC) and serum iron levels compared to ESAs.
  • Early administration of ESAs in preterm infants significantly reduced the need for RBC transfusions, lowered the incidence of severe conditions such as necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), and periventricular leukomalacia (PVL), and improved neurodevelopmental outcomes by 18-22 months.
  • In CKD patients, epoetin beta was associated with an increased risk of hypertension compared to placebo, while other ESAs, such as epoetin alfa, darbepoetin alfa, and methoxy polyethylene glycol-epoetin beta, were similarly linked to heightened hypertension risk, with higher doses of ESAs correlating to increased mortality risks in both adult and pediatric CKD populations.
  • In preterm infants, early administration of ESAs reduced the incidence of serious conditions, including necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), and periventricular leukomalacia (PVL), without significantly affecting mortality rates or severe retinopathy of prematurity (ROP).
  • For CKD patients, recombinant human EPO (rHuEPO) showed specific cognitive benefits, and ESA therapies were effective in managing anemia with variable safety outcomes; for pediatric CKD patients, adverse effects included hypertension and increased mortality risk at high ESA doses. In preterm infants, early initiation of ESA therapy reduced RBC transfusions, NEC, IVH, and PVL, and improved neurodevelopmental outcomes by 18 to 22 months.

Product Monograph / Prescribing Information

Document TitleYearSource
Aranesp (darbepoetin alfa) Prescribing Information.2024Amgen Inc., Thousand Oaks, CA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines