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Erythropoietin

Generic Name
Erythropoietin
Brand Names
Procrit, Eprex, Epprex, Epoetin Alfa Hexal, Silapo, Biopoin, Abseamed, Eporatio, NeoRecormon, Epogen, Retacrit
Drug Type
Biotech
Chemical Formula
-
CAS Number
11096-26-7
Unique Ingredient Identifier
64FS3BFH5W
Background

Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow . Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures . It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market . The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product . Epoetin alfa formulations can be administered intravenously or subcutaneously.

Indication

用于肾功能不全合并的贫血,艾滋病本身或因治疗引起的贫血,恶性肿瘤伴发的贫血及风湿性贫血等。另外,为择期手术储存自体血而反复采血的患者,同时应用本品可预防发生贫血。

Associated Conditions
Anemia, Blood Loss During Surgery, Anemia caused by Zidovudine
Associated Therapies
-

Anemia in Patients With a Non-Myeloid Malignancy

Phase 3
Completed
Conditions
Anemia
Neoplasms
Interventions
First Posted Date
2002-05-29
Last Posted Date
2008-09-15
Lead Sponsor
Amgen
Target Recruit Count
707
Registration Number
NCT00038064
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