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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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Use convenient Aranesp® QW and Q2W dosing for timely interventions1,2

Unpredictable clinical events may cause Hb changes that create challenges for patients on dialysis and healthcare professionals3-8

Unpredictable clinical events could include

  • Hospitalization5-8
  • Infection5-6
  • Inflammation5,6
  • Number/Severity of comorbidities6,8

Aranesp® safety and efficacy were similar between adults and pediatric patients with CKD when Aranesp® was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Aranesp®.

In patients with CKD on hemodialysis, 69% had unpredictable clinical events and 90% overall had Hb changes9

Based on a 6-month, retrospective analysis of all Medicare primary payer hemodialysis patients who survived and had ESA claims in the first 6 months of 2004 (N = 159,720).

*Unpredictable clinical events patients experienced during the 6-month study included hospitalization, vascular access insertions/complications, or receipt of IV antibiotics (ie, more serious infections) during the 6-month study.

Patients were classified as "experienced changes in Hb" if their Hb levels fluctuated during the 6-month period in the following patterns: low to intermediate, intermediate to high, or low to high.

In adults patients with CKD on dialysis: Address Hb changes by intervening with Aranesp®1,2

  • Initiate Aranesp® (darbepoetin alfa) treatment when Hb is < 10 g/dL
  • Increases in Hb usually occur within 2 to 6 weeks
  • A single Hb excursion may not require a dosing change

Intervene to address Hb excursions

  • Reduce or interrupt dose if the Hb level approaches or exceeds 11 g/dL in adult patients with CKD on dialysis
  • Decreases in dose can occur as clinically appropriate
  • Avoid frequent dose adjustments

Intervene to address Hb decline

  • Do not increase the dose more frequently than once every 4 weeks

Important Dosing Considerations

  • For patients who do not respond adequately over a 12-week escalation period, increasing the dose further is unlikely to improve response and may increase risks.
  • Use the lowest dose that will maintain a Hb sufficient to reduce the need for RBC transfusions.

Please see additional important Dosing Information

Aranesp® combines the convenience of QW and Q2W dosing options and an ability to intervene to help address Hb changes1,2

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.

Scroll down for additional
Important Safety Information.

Abbreviations and References:
QW = once weekly; Q2W = once every 2 weeks; Hb = hemoglobin.
References: 1. Aranesp® (darbepoetin alfa) prescribing information, Amgen. 2. Khan I, Krishnan M, Kothawala A, Ashfaq A. Association of dialysis facility-level hemoglobin measurement and erythropoiesis-stimulating agent dose adjustment frequencies with dialysis facility-level hemoglobin variation: a retrospective analysis. BMC Nephrol. 2011;12:22. 3. United States Renal Data System. 2009 Annual Data Report. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2009. 4. United States Renal Data System. 2011 Annual Data Report. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2011. 5. Solid CA, Foley RN, Gilbertson DT, Collins AJ. Perihospitalization hemoglobin-epoetin associations in U.S. hemodialysis patients, 1998 to 2003. Hemodial Int. 2007;11(4):442-447. 6. Ebben JP, Gilbertson DT, Foley RN, Collins AJ. Hemoglobin level variability: associations with comorbidity, intercurrent events, and hospitalizations. Clin J Am Soc Nephrol. 2006;1(16):1205-1210. 7. Chan KE, Lazarus JM, Wingard RL, Hakim RM. Association between repeat hospitalization and early intervention in dialysis patients following hospital discharge. Kidney Int. 2009;76(3):331-341. 8. Bradbury BD, Critchlow CW, Weir MR, Stewart R, Krishnan M, Hakim RH. Impact of elevated C-reactive protein levels on erythropoiesis-stimulating agent (ESA) dose and responsiveness in hemodialysis patients. Nephrol Dial Transplant. 2009;24(3):919-925. 9. Gilbertson DT, Peng Y, Bradbury B, Ebben JP, Collins AJ. Hemoglobin level variability: anemia management among variability groups. Am J Nephrol. 2009;30(6):491-498.