MedPath

Erythropoietin

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

Overview

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.

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

FDA Approved Products

PROCRIT
Manufacturer:Janssen Products, LP
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:2000 [iU] in 1 mL
Approved: 2023/11/01
NDC:59676-302
PROCRIT
Manufacturer:Janssen Products, LP
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:4000 [iU] in 1 mL
Approved: 2023/11/01
NDC:59676-304
PROCRIT
Manufacturer:Janssen Products, LP
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:10000 [iU] in 1 mL
Approved: 2023/11/01
NDC:59676-310
PROCRIT
Manufacturer:Janssen Products, LP
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:20000 [iU] in 1 mL
Approved: 2023/11/01
NDC:59676-320
PROCRIT
Manufacturer:Physicians Total Care, Inc.
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:40000 [iU] in 1 mL
Approved: 2013/01/17
NDC:54868-5802

Singapore Approved Products

EPREX 6000 PREFILLED SYRINGE 6000 iu/0.6 ml
Manufacturer:CILAG AG
Form:INJECTION
Strength:6000 iu/0.6 ml
Online:Yes
Approved: 2001/05/04
Approval:SIN11508P
EPREX 10000 PREFILLED SYRINGES 10000 iu/ml
Manufacturer:Cilag AG
Form:INJECTION
Strength:10000 iu/ml
Online:Yes
Approved: 1995/12/21
Approval:SIN08486P
RECORMON PRE-FILLED SYRINGE 2000 iu/0.3 ml
Manufacturer:ROCHE DIAGNOSTICS GMBH, Vetter Pharma-Fertigung GmbH & Co KG, F. Hoffmann-La Roche AG
Form:INJECTION
Strength:2000 iu/0.3 ml
Online:Yes
Approved: 2000/11/01
Approval:SIN11418P
EPREX 4000 PREFILLED SYRINGE 4000 iu/0.4 ml
Manufacturer:CILAG AG
Form:INJECTION
Strength:4000 iu/0.4 ml
Online:Yes
Approved: 1995/12/21
Approval:SIN08489P
EPREX 2000 PREFILLED SYRINGES 2000 iu/0.5 ml
Manufacturer:CILAG AG
Form:INJECTION
Strength:2000 iu/0.5 ml
Online:Yes
Approved: 1995/12/21
Approval:SIN08488P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath