Darbepoetin alfa

Use of darbepoetin alfa is contraindicated in patients with hypersensitivity to the drug, pre-existing uncontrolled hypertension, and pure red cell aplasia."Darbepoetin Alfa (Lexi-Drugs)". LexiComp. Retrieved 29 October 2014.

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.{{cite web | title=Aranesp- darbepoetin alfa injection, solution Aranesp- darbepoetin alfa solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fd36cb9-c4f6-4167-93c9-8530865db3f9 | access-date=7 April 2020}}

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).{{cite news | vauthors = Pollack A | title=Amgen Finds Anemia Drug Holds Risks in Cancer Use | url=https://www.nytimes.com/2007/01/26/business/26amgen.html?th&emc=th | newspaper=The New York Times |date=26 January 2007 |access-date=27 January 2007 }}{{medcn|date=February 2015}} Other reported adverse reactions include increased risk of seizure, hypotension, and chest pain.{{cite book | vauthors = Vest LS, Patel P, Patel JB | chapter = Epoetin Alfa | date = June 2024 | title = StatPearls [Internet]. | location = Treasure Island (FL) | publisher = StatPearls Publishing | pmid = 32119434 | chapter-url = https://www.ncbi.nlm.nih.gov/books/NBK554547/}}

Darbepoetin alfa is not assigned a pregnancy category in the United States.

It is not known if darbepoetin alfa is excreted in breast milk.

Darbepoetin alfa binds to the erythropoietin receptor on erythroid progenitor cells, stimulating RBC production and differentiation.

Amgen sent a "dear stockholders" letter in January 2007, that highlighted results from a recent anemia of cancer trial, and warned doctors to consider use in that off-label indication with caution.{{Cite web|last=Amgen|date=2007|title=Amgen 2007 Annual Report and Financial Summary|url=https://investors.amgen.com/static-files/5a4e76cb-55c8-48ff-b1a1-f4098e7f6d74|access-date=24 January 2022|archive-date=24 January 2022|archive-url=https://web.archive.org/web/20220124122903/https://investors.amgen.com/static-files/5a4e76cb-55c8-48ff-b1a1-f4098e7f6d74|url-status=dead}}

Amgen advised the U.S. Food and Drug Administration (FDA) as to the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that 3-year loco-regional control in subjects treated with Aranesp was significantly worse than for those not receiving Aranesp (p=0.01).{{cite journal | vauthors = Wauters I, Pat K, Vansteenkiste J | title = Flexible dosing with Darbepoetin alfa for the treatment of chemotherapy-induced anemia | journal = Therapeutics and Clinical Risk Management | volume = 2 | issue = 2 | pages = 175–186 | date = June 2006 | doi = 10.2147/tcrm.2006.2.2.175 | doi-access = free | pmid = 18360591 | pmc = 1661657 }}

In response to these advisories, the FDA released a Public Health Advisory{{cite web|url=https://www.fda.gov/cder/drug/advisory/RHE2007.htm |title=FDA Public Health Advisory: Erythropoiesis-Stimulating Agents (ESAs): Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) |website=Food and Drug Administration |access-date=5 June 2007 |archive-url=https://web.archive.org/web/20070528103823/https://www.fda.gov/cder/drug/advisory/RHE2007.htm |archive-date=28 May 2007 |url-status=dead }}

on 9 March 2007, and a clinical alert{{cite web|url=https://www.fda.gov/cder/drug/InfoSheets/HCP/RHE2007HCP.htm |title=Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA) |website=Food and Drug Administration |access-date=5 June 2007 |archive-url=https://web.archive.org/web/20070515034509/https://www.fda.gov/cder/drug/InfoSheets/HCP/RHE2007HCP.htm |archive-date=15 May 2007 |url-status=dead }} for doctors on 16 February 2007, about the use of erythropoeisis-stimulating agents (ESAs) such as epoetin alfa (marketed as Epogen) 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.{{cite journal | vauthors = Rizzo JD, Brouwers M, Hurley P, Seidenfeld J, Arcasoy MO, Spivak JL, Bennett CL, Bohlius J, Evanchuk D, Goode MJ, Jakubowski AA, Regan DH, Somerfield MR | title = American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer | journal = Journal of Clinical Oncology | volume = 28 | issue = 33 | pages = 4996–5010 | date = November 2010 | pmid = 20975064 | pmc = 2988667 | doi = 10.1200/jco.2010.29.2201 | url = http://www.asco.org/quality-guidelines/asco-ash-clinical-practice-guideline-update-use-epoetin-and-darbepoetin-adult | url-status = dead | archive-url = https://web.archive.org/web/20141103190540/http://www.asco.org/quality-guidelines/asco-ash-clinical-practice-guideline-update-use-epoetin-and-darbepoetin-adult | archive-date = 3 November 2014 }}

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 of Russia, Olga Danilova of Russia and Johann Mühlegg of Spain from their final races.{{cite news | vauthors = McGrath M, Portal G |title=New drugs give cheats the edge |url= http://news.bbc.co.uk/2/hi/science/nature/1789625.stm |access-date=3 November 2014 |work=BBC News Online |date=30 January 2002 }}

Epogen and Aranesp had more than $6 billion in combined sales in 2006.{{Cite web |last=((staff-author)) |date=14 March 2007 |title=FDA to Study Amgen Drugs |url=https://labusinessjournal.com/news/fda-to-study-amgen-drugs/ |access-date=8 June 2024 |website=Los Angeles Business Journal |language=en-US}} Procrit sales were about $3.2 billion in 2006.[https://fr.reuters.com/article/idUSN1042384920070510]{{dead link|date=July 2021|bot=medic}}{{cbignore|bot=medic}}

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Category:Antianemic preparations

Category:Growth factors

Category:Erythropoiesis-stimulating agents

Category:Orphan drugs