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Indication

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia... read more

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. read more

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

Limitations of Use

  • Aranesp® has not been shown to improve quality of life, fatigue, or patient well-being.
  • Aranesp® is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
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The nephrology landscape continues to evolve1
Hemoglobin (Hb) levels declined from 2011 to 20142

Data are from OutcomesPlus, a national database of clinical data from patients receiving dialysis in facilities across the US, excluding hospital and governmental entity patients. It contains information about approximately 80% to 85% of the entire US dialysis population. Subjects were categorized based on their mean Hb measurement during the first quarter.

Aranesp® median weekly dose declined from January 2010 to December 20113

Observational analysis of data from the Amgen-sponsored eRADICAL study, including electronic medical records (EMR) data from 61 US hospital-based dialysis centers between January 2010 and December 2011. The EMR contained information for hemodialysis patients ≥ 18 years of age, ≥ 1 Hb measurement, and ≥ 1 ESA dose. The population ranged from 1,971 to 2,194 patients per month.

For patients with CKD on dialysis

  • Initiate Aranesp® treatment when the Hb level is < 10 g/dL.
  • Individualize dosing and use the lowest dose of Aranesp® sufficient to reduce the need for RBC transfusions.
  • Aranesp® is not indicated as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Important Safety Information

WARNING - Chronic Kidney Disease:

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, Aranesp® dose, or dosing strategy that does not increase these risks.
  • Use the lowest Aranesp® dose sufficient to reduce the need for red blood cell (RBC) transfusions.

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Important Safety Information.

Abbreviations and References:
ESA = erythropoiesis-stimulating agent; Hb = hemoglobin; RBC = red blood cell.
Reference: 1. Fuller DS, Pisoni RL, Bieber BA, Gillespie BW, Robinson BM. The DOPPS practice monitor for US dialysis care: trends through December 2011 [published online ahead of print November 5, 2012]. Am J Kidney Dis. doi:10.1053/j.ajkd.2012.10.002. 2. Data on file. Amgen; [OutcomesPlus database; July 2014]. 3. Data on file. Amgen; [Hospital-Based Dialysis Center Electronic Medical Record (EMR) system].