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.

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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. In 2002, Aranesp® was also approved in the United States and Europe for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. 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 not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy. 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 TUMOR PROGRESSION

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 time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of > 12 g/dL.
  • The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.
  • To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.
  • Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
  • Discontinue following the completion of a chemotherapy course.

Aranesp® is contraindicated in patients with uncontrolled hypertension.