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
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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- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- 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 stimulatorHumans - 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
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbemaciclib 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. 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. Alectinib The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Alectinib. Alemtuzumab The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Alemtuzumab. Alitretinoin The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Alitretinoin. Alpelisib The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Alpelisib. Altretamine The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Altretamine. Aminoglutethimide The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Aminoglutethimide. 
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- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Mircera Injection, solution 250 ug/0.3mL Intravenous Vifor (International) Inc. 2014-10-24 Not applicable US 
Mircera Injection, solution 75 μg/0.3ml Intravenous; Subcutaneous Roche Registration Gmb H 2016-09-08 Not applicable EU 
Mircera Injection, solution 120 ug/0.3mL Intravenous Vifor (International) Inc. 2014-10-24 Not applicable US Mircera Solution 300 mcg / mL Intravenous; Subcutaneous Hoffmann La Roche Not applicable Not applicable Canada 
Mircera Injection, solution 50 μg/0.3ml Intravenous; Subcutaneous Roche Registration Gmb H 2016-09-08 Not applicable EU Mircera Injection, solution 120 μg/0.3ml Intravenous; Subcutaneous Roche Registration Gmb H 2016-09-08 Not applicable EU Mircera Injection, solution 50 ug/0.3mL Intravenous Vifor (International) Inc. 2014-10-24 Not applicable US Mircera Solution 50 mcg / mL Intravenous; Subcutaneous Hoffmann La Roche Not applicable Not applicable Canada Mircera Solution 400 mcg / 0.6 mL Intravenous; Subcutaneous Hoffmann La Roche Not applicable Not applicable Canada Mircera Solution 150 mcg / 0.3 mL Intravenous; Subcutaneous Hoffmann La Roche Not applicable Not applicable Canada
Categories
- ATC Codes
- B03XA03 — Methoxy polyethylene glycol-epoetin beta
- Drug Categories
- Alcohols
- Amino Acids, Peptides, and Proteins
- Antianemic Preparations
- Biological Factors
- Blood and Blood Forming Organs
- Colony-Stimulating Factors
- Compounds used in a research, industrial, or household setting
- Cytokines
- Erythropoiesis-Stimulating Agents
- Ethylene Glycols
- 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
- External Links
- PubChem Substance
- 347910408
- 729596
- Wikipedia
- Methoxy_polyethylene_glycol-epoetin_beta
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Basic Science Renal Anemia 1 4 Completed Treatment Anemia 8 4 Completed Treatment Anemia of End Stage Renal Disease 1 4 Completed Treatment Anemia, Kidney Disease, Chronic 1 4 Completed Treatment Anemia / Inflammation / Malnutrition 1 4 Completed Treatment Renal Anemia, Chronic 1 4 Terminated Treatment Anemia 2 4 Unknown Status Treatment PD 1 3 Active Not Recruiting Treatment Anaemia Associated With Chronic Kidney Disease 1 3 Active Not Recruiting Treatment Anemia Associated With Chronic Kidney Disease (CKD) 1
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 μg/0.3ml Injection, solution Intravenous; Subcutaneous 100 MCG 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 MCG Injection, solution Intravenous; Subcutaneous 250 μg/0.3ml 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 μg/0.6ml Injection, solution Intravenous; Subcutaneous 360 MCG/0.3ML 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 MCG Injection, solution Intravenous; Subcutaneous 50 μg/0.3ml 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 / mL Solution Intravenous; Subcutaneous 100 mcg / 0.3 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 / mL Solution Intravenous; Subcutaneous 50 mcg / 0.3 mL Solution Intravenous; Subcutaneous 600 mcg / mL Solution Intravenous; Subcutaneous 600 mcg / 0.6 mL Solution Intravenous; Subcutaneous 75 mcg / 0.3 mL Injection, solution Intravenous; Subcutaneous 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 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 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 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 Canada
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
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- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Stimulator
- General Function
- Identical protein binding
- Specific Function
- Receptor for erythropoietin. Mediates erythropoietin-induced erythroblast proliferation and differentiation. Upon EPO stimulation, EPOR dimerizes triggering the JAK2/STAT5 signaling cascade. In som...
- Gene Name
- EPOR
- Uniprot ID
- P19235
- Uniprot Name
- Erythropoietin receptor
- Molecular Weight
- 55064.725 Da
Drug created at September 16, 2015 23:06 / Updated at December 01, 2022 23:18