Methoxy polyethylene glycol-epoetin beta

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Identification

Summary

Methoxy polyethylene glycol-epoetin beta is a synthetic erythropoiesis stimulating agent (ESA) used to treat anemia associated with chronic kidney disease.

Brand Names

Mircera

Generic Name

Methoxy polyethylene glycol-epoetin beta

DrugBank Accession Number

DB09107

Background

Methoxy polyethylene glycol-epoetin beta is a chemically synthesised Erythropoiesis Stimulating Agent (ESA) with a longer half-life than erythropoietin. ESA is used to increase synthesis of red blood cells to treat chronic kidney disease associated anemia.

Type

Biotech

Groups

Approved

Biologic Classification

Protein Based Therapies
Haematopoietic growth factors

Protein Chemical Formula

Not Available

Protein Average Weight

Not Available

Sequences

Not Available

Synonyms

• CERA
• Pegzerepoetin alfa

External IDs

• R-744
• R744

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Pharmacology

Indication

For the treatment of patients with anaemia associated with chronic kidney disease. Not a substitute for RBC transfusion if immediate correction of anemia is required.

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Associated Conditions

Indication Type	Indication	Combined Product Details	Approval Level	Age Group	Patient Characteristics	Dose Form
Treatment of	Anemia		••••••••••••

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Pharmacodynamics

Stimulates hemoglobin production by stimulating the erythropoetin receptor of erythroid progenitor cells in the bone marrow. Hemoglobin increase, following a single initial dose, occurs 7 to 15 days after.

Mechanism of action

Erythropoietin is a growth factor for erythroid development. It is produced in the kidney and released into the bloodstream in response to hypoxia, interacting with erythroid progenitor cells to increase red blood cell production. Production of endogenous erythropoietin is impaired in patients with chronic kidney disease (CKD), and erythropoietin deficiency is the primary cause of their anaemia. Administration of methoxy polyethylene glycol-epoetin beta acts like endogenous erythropoetin and stimulates erythropoetin receptor of the erythroid progenitor cells in the bone marrow.

Target	Actions	Organism
AErythropoietin receptor	stimulator	Humans

Absorption

Administered parenterally (subcutaneous or IV) therefore not absorbed.

Volume of distribution

~94.74 ml/kg

Protein binding

No protein binding

Metabolism

Not metabolized.

Route of elimination

Undergoes proteolysis at erythropoietin receptor

Half-life

In CKD patients on peritoneal dialysis with IV administration: 134 ± 65 hours In CKD patients on peritoneal dialysis with SC administration: 139 ± 67 hours

Clearance

In CKD patients on peritoneal dialysis : 0.49 ± 0.18 mL/hr/kg

Adverse Effects

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Toxicity

Overdosage can cause severe hypertension.

Pathways

Not Available

Pharmacogenomic Effects/ADRs

Not Available

Interactions

Drug Interactions

This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

• Approved
• Vet approved
• Nutraceutical
• Illicit
• Withdrawn
• Investigational
• Experimental
• All Drugs

Drug	Interaction
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Abemaciclib	The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Abemaciclib.
Abiraterone	The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Abiraterone.
Adagrasib	The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Adagrasib.
Afatinib	The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Afatinib.
Aldesleukin	The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Aldesleukin.

Food Interactions

No interactions found.

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Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End	Region	Image
Mircera	Injection, solution	75 μg/0.3ml	Intravenous; Subcutaneous	Roche Registration Gmbh	2016-09-08	Not applicable
Mircera	Injection, solution	250 ug/0.3mL	Intravenous	Genentech, Inc.	2014-10-24	2019-07-31
Mircera	Solution	100 mcg / mL	Intravenous; Subcutaneous	Hoffmann La Roche	Not applicable	Not applicable
Mircera	Solution	400 mcg / 0.6 mL	Intravenous; Subcutaneous	Hoffmann La Roche	Not applicable	Not applicable
Mircera	Solution	200 mcg / 0.3 mL	Intravenous; Subcutaneous	Hoffmann La Roche	Not applicable	Not applicable

Categories

ATC Codes

B03XA03 — Methoxy polyethylene glycol-epoetin beta

• B03XA — Other antianemic preparations
• B03X — OTHER ANTIANEMIC PREPARATIONS
• B03 — ANTIANEMIC PREPARATIONS
• B — BLOOD AND BLOOD FORMING ORGANS

Drug Categories

• Alcohols
• Amino Acids, Peptides, and Proteins
• Antianemic Preparations
• Biological Factors
• Blood and Blood Forming Organs
• Carbohydrates
• Colony-Stimulating Factors
• Compounds used in a research, industrial, or household setting
• Cytokines
• Erythropoiesis-Stimulating Agents
• Ethylene Glycols
• Glycoconjugates
• Glycols
• Glycoproteins
• Hematinics
• Hematopoietic Cell Growth Factors
• Increased Erythroid Cell Production
• Intercellular Signaling Peptides and Proteins
• Macromolecular Substances
• Pegylated agents
• Peptides
• Polymers
• Proteins

Chemical TaxonomyProvided by Classyfire

Description

Not Available

Kingdom

Organic Compounds

Super Class

Organic Acids

Class

Carboxylic Acids and Derivatives

Sub Class

Amino Acids, Peptides, and Analogues

Direct Parent

Peptides

Alternative Parents

Not Available

Substituents

Not Available

Molecular Framework

Not Available

External Descriptors

Not Available

Affected organisms

Not Available

Chemical Identifiers

UNII

LR3UXN0193

CAS number

677324-53-7

References

General References

1. Walrafen P, Verdier F, Kadri Z, Chretien S, Lacombe C, Mayeux P: Both proteasomes and lysosomes degrade the activated erythropoietin receptor. Blood. 2005 Jan 15;105(2):600-8. Epub 2004 Sep 9. [Article]
2. Daily Med Micera Monograph [Link]

External Links

PubChem Substance

347910408

RxNav

729596

Wikipedia

Methoxy_polyethylene_glycol-epoetin_beta

Clinical Trials

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Phase	Status	Purpose	Conditions	Count	Start Date	Why Stopped	100+ additional columns
Unlock 175K+ rows when you subscribe.View sample data
Not Available	Completed	Not Available	Anemia	3	somestatus	stop reason	just information to hide
Not Available	Completed	Not Available	Anemia, Kidney Transplantation	1	somestatus	stop reason	just information to hide
Not Available	Completed	Not Available	Chronic Kidney Disease (CKD)	3	somestatus	stop reason	just information to hide
Not Available	Completed	Not Available	Impaired Renal Function / Renal Anemia of Chronic Kidney Disease	1	somestatus	stop reason	just information to hide
Not Available	Completed	Not Available	Renal Anemia of Chronic Kidney Disease	1	somestatus	stop reason	just information to hide

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Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Form	Route	Strength
Injection, solution	Intravenous	100 ug/0.3mL
Injection, solution	Intravenous	120 ug/0.3mL
Injection, solution	Intravenous	150 ug/0.3mL
Injection, solution	Intravenous	200 ug/0.3mL
Injection, solution	Intravenous	250 ug/0.3mL
Injection, solution	Intravenous	30 ug/0.3mL
Injection, solution	Intravenous	360 ug/0.6mL
Injection, solution	Intravenous	50 ug/0.3mL
Injection, solution	Intravenous	75 ug/0.3mL
Injection, solution	Intravenous; Subcutaneous	100 MCG
Injection, solution	Intravenous; Subcutaneous	100 μg/0.3ml
Injection, solution	Intravenous; Subcutaneous	1000 MCG
Injection, solution	Intravenous; Subcutaneous	120 MCG/0.3ML
Injection, solution	Intravenous; Subcutaneous	120 μg/0.3ml
Injection, solution	Intravenous; Subcutaneous	150 μg/0.3ml
Injection, solution	Intravenous; Subcutaneous	150 MCG
Injection, solution	Intravenous; Subcutaneous	200 μg/0.3ml
Injection, solution	Intravenous; Subcutaneous	200 MCG
Injection, solution	Intravenous; Subcutaneous	250 μg/0.3ml
Injection, solution	Intravenous; Subcutaneous	250 MCG
Injection, solution	Intravenous; Subcutaneous	30 MCG/0.3ML
Injection, solution	Intravenous; Subcutaneous	30 μg/0.3ml
Injection, solution	Intravenous; Subcutaneous	300 MCG
Injection, solution	Intravenous; Subcutaneous	360 MCG/0.3ML
Injection, solution	Intravenous; Subcutaneous	360 μg/0.6ml
Injection, solution	Intravenous; Subcutaneous	40 μg/0.3ml
Injection, solution	Intravenous; Subcutaneous	40 MCG/0.3ML
Injection, solution	Intravenous; Subcutaneous	400 MCG
Injection, solution	Intravenous; Subcutaneous	50 μg/0.3ml
Injection, solution	Intravenous; Subcutaneous	50 MCG
Injection, solution	Intravenous; Subcutaneous	60 MCG/0.3ML
Injection, solution	Intravenous; Subcutaneous	60 μg/0.3ml
Injection, solution	Intravenous; Subcutaneous	600 MCG
Injection, solution	Intravenous; Subcutaneous	75 MCG
Injection, solution	Intravenous; Subcutaneous	75 μg/0.3ml
Injection, solution	Intravenous; Subcutaneous	800 MCG
Solution	Intravenous; Subcutaneous	100 mcg / 0.3 mL
Solution	Intravenous; Subcutaneous	100 mcg / mL
Solution	Intravenous; Subcutaneous	1000 mcg / mL
Solution	Intravenous; Subcutaneous	150 mcg / 0.3 mL
Solution	Intravenous; Subcutaneous	200 mcg / 0.3 mL
Solution	Intravenous; Subcutaneous	200 mcg / mL
Solution	Intravenous; Subcutaneous	250 mcg / 0.3 mL
Solution	Intravenous; Subcutaneous	300 mcg / mL
Solution	Intravenous; Subcutaneous	400 mcg / mL
Solution	Intravenous; Subcutaneous	400 mcg / 0.6 mL
Solution	Intravenous; Subcutaneous	50 mcg / 0.3 mL
Solution	Intravenous; Subcutaneous	50 mcg / mL
Solution	Intravenous; Subcutaneous	600 mcg / 0.6 mL
Solution	Intravenous; Subcutaneous	600 mcg / mL
Solution	Intravenous; Subcutaneous	75 mcg / 0.3 mL
Solution	Parenteral	50.000 mcg
Injection, solution	Intravenous; Subcutaneous	100 mcg/mL
Injection, solution	Parenteral	100 UG/0.3ML
Injection, solution	Parenteral	100 µg/0.3ml
Injection, solution	Parenteral	120 UG/0.3ML
Injection, solution	Parenteral	120 µg/0.3ml
Injection, solution	Parenteral	150 UG/0.3ML
Injection, solution	Parenteral	150 µg/0.3ml
Injection, solution	Parenteral	200 UG/0.3ML
Injection, solution	Parenteral	200 µg/0.3ml
Injection	Intravenous; Subcutaneous
Injection, solution	Parenteral	250 UG/0.3ML
Injection, solution	Parenteral	250 µg/0.3ml
Injection, solution	Parenteral	30 UG/0.3ML
Injection, solution	Parenteral	30 µg/0.3ml
Injection, solution	Intravenous; Subcutaneous
Injection, solution	Parenteral	360 UG/0.6ML
Injection, solution	Parenteral	360 µg/0.3ml
Injection, solution	Parenteral	50 UG/0.3ML
Injection, solution	Parenteral	50 µg/0.3ml
Injection, solution	Parenteral	75 UG/0.3ML
Injection, solution	Parenteral	75 µg/0.3ml
Injection	Intravenous; Subcutaneous	800 mcg
Solution	Intravenous; Subcutaneous	30 mcg
Injection, solution	Intravenous; Subcutaneous	100 mcg/0.3ml
Injection, solution	Intravenous; Subcutaneous	50 mcg/0.3ml
Injection, solution	Intravenous; Subcutaneous	75 mcg/0.3ml
Solution	Intravenous; Subcutaneous	200 MCG/0.3ML
Solution	Intravenous; Subcutaneous	250 MCG/0.3ML
Solution	Intravenous; Subcutaneous	30 mcg/0.3mL
Solution	Intravenous; Subcutaneous	360 mcg/0.6mL
Solution	Intravenous; Subcutaneous	800 MCG/0.6ML
Solution	Intravenous; Subcutaneous	100 mcg
Solution	Intravenous; Subcutaneous	150 mcg
Solution	Intravenous; Subcutaneous	250 cg
Solution	Intravenous; Subcutaneous	50 cg
Solution	Intravenous; Subcutaneous	100 cg
Solution	Intravenous; Subcutaneous	1000 cg
Solution	Intravenous; Subcutaneous	200 cg
Solution	Intravenous; Subcutaneous	0.3 mg
Solution	Intravenous; Subcutaneous	120 cg
Solution	Intravenous; Subcutaneous	100 mcg/0.3ml
Solution	Intravenous; Subcutaneous	120 mcg/0.3ml
Solution	Intravenous; Subcutaneous	150 mcg/0.3ml
Solution	Intravenous; Subcutaneous	50 mcg/0.3ml
Solution	Intravenous; Subcutaneous	75 mcg/0.3ml

Prices

Not Available

Patents

Patent Number	Pediatric Extension	Approved	Expires (estimated)	Region
CA2310536	No	2007-09-11	2020-06-28

Properties

State

Solid

Experimental Properties

Not Available

Targets

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Details1. Erythropoietin receptor

Kind

Protein

Organism

Humans

Pharmacological action

Yes

Actions

Stimulator

General Function

Receptor for erythropoietin, which mediates erythropoietin-induced erythroblast proliferation and differentiation (PubMed:10388848, PubMed:2163695, PubMed:2163696, PubMed:8662939, PubMed:9774108). Upon EPO stimulation, EPOR dimerizes triggering the JAK2/STAT5 signaling cascade (By similarity). In some cell types, can also activate STAT1 and STAT3 (PubMed:11756159). May also activate the LYN tyrosine kinase (By similarity)

Specific Function

erythropoietin receptor activity

Gene Name

EPOR

Uniprot ID

P19235

Uniprot Name

Erythropoietin receptor

Molecular Weight

55064.725 Da

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Drug created at September 16, 2015 23:06 / Updated at October 11, 2024 18:19