|Trade names||Aranesp, Cresp, others|
|Drug class||Erythropoietin analogue|
|Main uses||Low red blood cells due to chronic kidney failure or chemotherapy|
|Side effects||High blood pressure, allergic reactions, swelling|
|Intravenous, subcutaneous injection|
|Chemical and physical data|
|Molar mass||18396.19 g·mol−1|
Darbepoetin alfa, sold under the brand name Aranesp among others, is a medication used to treat low red blood cells due to chronic kidney failure or chemotherapy. It is given by injection into a vein or under the skin. Doses to achieve a hemoglobin greater than 110 g/L (11 g/dL) is not recommended.
Common side effects may include high blood pressure, allergic reactions, and swelling. Other side effect may include blood clots and worsened cancer. It works in the same way as erythropoietin, to increase red blood cell production by the bone marrow. It is made by recombinant DNA technology.
Darbepoetin alfa was approved for medical use in the United States and Europe in 2001. In the United Kingdom 4 weeks at a dose of 40 micrograms per week costs the NHS about £235. This amount in the United States costs about 1,200 USD.
For people with chronic kidney disease it is often started at 450 nanograms per kg once per week. In chemotherapy 2,250 nanograms per kg per week may be used. It may be possible to give every 3 weeks instead of every week.
Use of darbepoetin alfa is contraindicated in patients with hypersensitivity to the drug, pre-existing uncontrolled hypertension, and pure red cell aplasia.
Darbepoetin alfa has black box warnings in the United States for increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. To avoid side effects, it is recommended for patients with chronic kidney failure or cancer to use the lowest possible dose needed to avoid red blood cell (RBC) transfusions.
In addition to those listed in the black box warning, use of darbepoetin alfa also increases the risk of cardiovascular problems, including cardiac arrest, arrhythmia, hypertension and congestive heart failure, and edema. A recent study has extended these findings to treatment of patients exhibiting cancer-related anemia (distinct from anemia resulting from chemotherapy).[medical citation needed] Other reported adverse reactions include increased risk of seizure, hypotension, and chest pain.
The FDA released a Public Health Advisory in March 2007, and a clinical alert in February 2007, about the use of erythropoeisis-stimulating agents (ESAs) such as epoetin alfa and darbepoetin alfa. The advisory recommended caution in using these agents in cancer patients receiving chemotherapy or off chemotherapy, and indicated a lack of clinical evidence to support improvements in quality of life or transfusion requirements in these settings.
According to the 2010 update to clinical practice guidelines from the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH), use of ESAs such as darbepoetin alfa in cancer patients is appropriate when following stipulations outlined in FDA-approved labeling.
Pregnancy and breastfeeding
Darbepoetin alfa is not assigned a pregnancy category in the United States.
Mechanism of action
Society and culture
Like EPO, darbepoetin alfa has the potential to be abused by athletes seeking a competitive advantage. Its use during the 2002 Winter Olympic Games to improve performance led to the disqualification of cross-country skiers Larisa Lazutina and Olga Danilova of Russia and Johann Mühlegg of Spain from their final races.
Dr. Reddy's Laboratories launched darbepoetin alfa in India under the brand name "Cresp" in August 2010.
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