Darbepoetin alfa

Darbepoetin alfa
Clinical data
AHFS/Drugs.com	Monograph
MedlinePlus	a604022
License data	EU EMA: by INN; US DailyMed: Darbepoetin_alfa; US FDA: Darbepoetin_alfa;
Pregnancy; category	AU: B3;
Routes of; administration	Intravenous, subcutaneous injection
ATC code	B03XA02 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); US: WARNINGRx-only; In general: ℞ (Prescription only);
Identifiers
CAS Number	209810-58-2 ;
DrugBank	DB00012 ;
ChemSpider	none;
UNII	15UQ94PT4P;
CompTox Dashboard (EPA)	DTXSID7039678 ;
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. 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.

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. 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.

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