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Aranesp® (darbepoetin alfa)
How it works:

Aranesp® is an erythropoietic protein that works in a similar way as the body’s natural erythropoietin — a glycoprotein produced by the kidneys that circulates through the bloodstream to bone marrow, where it stimulates red blood cell production. Red blood cells perform the essential function of transporting oxygen throughout the body. When the kidneys fail, production of erythropoietin decreases and the production of red blood cells is hindered, usually resulting in anemia. Certain cancer patients undergoing chemotherapy also suffer from anemia.

Related Links:

Aranesp® Prescribing Information and
Medication Guide
www.aranesp.com


Introduced in 2001, Aranesp® is approved in the United States, most countries in Europe, Canada, Australia, and New Zealand for the treatment of anemia associated with chronic renal failure in patients both on dialysis and not on dialysis.

Aranesp® is indicated for the treatment of anemia associated with chronic renal failure (CRF), including patients on dialysis and patients not on dialysis. 

Aranesp® is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for red blood cell transfusions in patients with metastatic, non-myeloid malignancies.  Studies to determine whether Aranesp® increases mortality or decreases progression-free/recurrence-free survival are ongoing.

  • Aranesp® is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
  • Aranesp® is not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure due to the absence of studies that adequately characterize the impact of Aranesp® on progression-free and overall survival.
  • Aranesp® use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being.
Aranesp® is a recombinant erythropoietic protein that stimulates production of oxygen-carrying red blood cells, with a longer half-life than Epoetin alfa.
 

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
  • To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
  • Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.

Aranesp® is contraindicated in patients with uncontrolled hypertension.

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