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| AHFS/Drugs.com | Monograph |
| MedlinePlus | a604022 |
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| Routes of administration | Intravenous, subcutaneous |
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| Chemical and physical data | |
| Formula | C815H1317N233O241S5 |
| Molar mass | 18396.19 g·mol−1 |
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Darbepoetin alfa (INN) /dɑːrbəˈpoʊɪtɪn/ is a re-engineered form of erythropoietin containing 5 amino acid changes (N30, T32, V87, N88, T90) resulting in the creation of 2 new sites for N-linked carbohydrate addition. It has a 3-fold longer serum half-life compared to epoetin alpha and epoetin beta. It stimulates erythropoiesis (increases red blood cell levels) by the same mechanism as rHuEpo (binding and activating the Epo receptor) and is used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy. Darbepoetin is marketed by Amgen under the trade name Aranesp.
The medication was approved in September 2001, by the US Food and Drug Administration for treatment of anemia in patients with chronic kidney failure by intravenous or subcutaneous injection.[4] In June 2001, it had been approved by the European Medicines Agency for this indication as well as the treatment of anemia in cancer patients undergoing chemotherapy.[5]
Dr. Reddy's Laboratories launched darbepoetin alfa in India under the brand name Cresp in August 2010. This is the world's first follow-on biologic of darbepoetin alfa.
Darbepoetin is produced by recombinant DNA technology in modified Chinese hamster ovary cells.[6] It differs from endogenous erythropoietin (EPO) by containing two more N-linked oligosaccharide chains. It is an erythropoiesis-stimulating 165-amino acid protein.
It is on the World Health Organization's List of Essential Medicines.[7]
- ^ "Darbepoetin alfa (Aranesp) Use During Pregnancy". Drugs.com. 31 December 2018. Retrieved 7 April 2020.
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ "Aranesp EPAR". European Medicines Agency. 8 June 2001. Retrieved 29 June 2024.
- ^ Siegel JP (17 September 2001). "Product Approval Information - Licensing Action". United States Food and Drug Administration. Archived from the original on 22 October 2006. Retrieved 27 January 2007.
- ^ "European Public Assessment Report (Abstract)" (PDF). European Medicines Agency. 8 June 2001. Archived from the original (PDF) on 17 October 2006. Retrieved 27 January 2007.
- ^ Smith RE, Jaiyesimi IA, Meza LA, Tchekmedyian NS, Chan D, Griffith H, et al. (April 2001). "Novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia of chronic disease associated with cancer". British Journal of Cancer. 84 (Suppl 1): 24–30. doi:10.1054/bjoc.2001.1749. PMC 2363901. PMID 11308271.
- ^ World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.