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Methoxy polyethylene glycol-epoetin beta
Identification
- Name
- Methoxy polyethylene glycol-epoetin beta
- Accession Number
- DB09107
- Description
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.
- Associated Conditions
- Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
Learn More- 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
Learn about our commercial Adverse Effects data.
Learn More- Toxicity
Overdosage can cause severe hypertension.
- Affected organisms
- Not Available
- 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 Unlock Additional DataAbemaciclib 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. Additional Data Available- Extended DescriptionExtended Description
Extended description of the mechanism of action and particular properties of each drug interaction.
Learn more - Severity
- Evidence Level
- ActionAction
An effect category for each drug interaction. Know how this interaction affects the subject drug.
Learn more
- Food Interactions
- Not Available
Products
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Unlock Additional DataMircera Injection, solution 150 ug/0.3mL Intravenous Genentech, Inc. 2014-10-24 2019-07-31 US 
Mircera Injection, solution 50 ug/0.3mL Intravenous Genentech, Inc. 2014-10-24 2019-05-31 US Mircera Solution 400 mcg Intravenous; Subcutaneous Hoffmann La Roche Not applicable Not applicable Canada 
Mircera Solution 400 mcg Intravenous; Subcutaneous Hoffmann La Roche Not applicable Not applicable Canada Mircera Injection, solution 50 μg/0.3ml Intravenous; Subcutaneous Roche Registration Gmb H 2007-07-20 Not applicable EU 
Mircera Injection, solution 30 μg/0.3ml Intravenous; Subcutaneous Roche Registration Gmb H 2007-07-20 Not applicable EU Mircera Injection, solution 360 ug/0.6mL Intravenous Vifor (International) Inc. 2014-10-24 Not applicable US Mircera Injection, solution 150 ug/0.3mL Intravenous Vifor (International) Inc. 2014-10-24 Not applicable US Mircera Injection, solution 60 μg/0.3ml Intravenous; Subcutaneous Roche Registration Gmb H 2007-07-20 Not applicable EU Mircera Injection, solution 75 ug/0.3mL Intravenous Vifor (International) Inc. 2014-10-24 Not applicable US Additional Data Available- Application NumberApplication Number
A unique ID assigned by the FDA when a product is submitted for approval by the labeller.
Learn more - Product CodeProduct Code
A governmentally-recognized ID which uniquely identifies the product within its regulatory market.
Learn more
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
- 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
Chemical Identifiers
- UNII
- LR3UXN0193
- CAS number
- 677324-53-7
References
- General References
- 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. [PubMed:15358619]
- Daily Med Micera Monograph [Link]
- External Links
- PubChem Substance
- 347910408
- 729596
- Wikipedia
- Methoxy_polyethylene_glycol-epoetin_beta
- AHFS Codes
- 20:16.00 — Hematopoietic Agents
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 / Inflammatory Reaction / Malnutrition 1 4 Completed Treatment Anemia / Renal Anemia, Chronic 1 4 Terminated Treatment Anemia 2 4 Unknown Status Treatment PD 1 3 Completed Treatment Anemia 32 3 Completed Treatment Anemia in Pre-Dialysis Patients 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 120 μg/0.3ml Injection, solution Intravenous; Subcutaneous 150 μg/0.3ml Injection, solution Intravenous; Subcutaneous 200 μg/0.3ml Injection, solution Intravenous; Subcutaneous 250 μg/0.3ml Injection, solution Intravenous; Subcutaneous 30 μg/0.3ml Injection, solution Intravenous; Subcutaneous 360 μg/0.6ml Injection, solution Intravenous; Subcutaneous 40 μg/0.3ml Injection, solution Intravenous; Subcutaneous 50 μg/0.3ml Injection, solution Intravenous; Subcutaneous 60 μg/0.3ml Injection, solution Intravenous; Subcutaneous 75 μg/0.3ml Solution Intravenous; Subcutaneous 100 mcg Solution Intravenous; Subcutaneous 1000 mcg Solution Intravenous; Subcutaneous 150 mcg Solution Intravenous; Subcutaneous 200 mcg Solution Intravenous; Subcutaneous 250 mcg Solution Intravenous; Subcutaneous 300 mcg Solution Intravenous; Subcutaneous 400 mcg Solution Intravenous; Subcutaneous 50 mcg Solution Intravenous; Subcutaneous 600 mcg Solution Intravenous; Subcutaneous 75 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 250 mcg 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 360 mcg/0.6mL 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 120 mcg/0.3ml Solution Intravenous; Subcutaneous 150 mcg/0.3ml Solution Intravenous; Subcutaneous 200 mcg/0.3ml Solution Intravenous; Subcutaneous 30 mcg/0.3ml Solution Intravenous; Subcutaneous 50 mcg/0.3ml Solution Intravenous; Subcutaneous 75 mcg/0.3ml Injection Intravenous; Subcutaneous 800 mcg Solution Solution Intravenous; Subcutaneous 50 cg - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region Unlock Additional DataCA2310536 No 2007-09-11 2020-06-28 Canada Additional Data Available- Filed On
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
- 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 on September 16, 2015 17:06 / Updated on September 22, 2020 02:10
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