epoetin beta/methoxy polyethylene glycol

Action and Spectrum

Actions and Spectrum: 

epoetin beta/methoxy polyethylene glycol stimulates the production of red blood cells (erythropoiesis) by acting as a synthetic form of erythropoietin. It binds to erythropoietin receptors on the surface of erythroid progenitor cells, leading to the proliferation and differentiation of these cells into mature red blood cells. 

epoetin beta/methoxy polyethylene glycol has been modified with polyethylene glycol to increase its half-life compared to regular erythropoietin. This modification allows for an extended duration of action and a longer interval between doses. 

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

Hypertension (13%) 

Nasopharyngitis (11%) 

Diarrhea (11%) 

1-10% 

Headache (9%) 

Upper respiratory tract infection (9%) 

Procedural hypotension (8%) 

Muscle spasms (8%) 

Fluid overload (7%) 

Cough (6%) 

Vomiting (6%) 

Back pain (6%) 

Hypotension (5%) 

Arteriovenous fistula site complication (5%) 

Pain in extremities (5%) 

Urinary tract infection (5%) 

Arteriovenous fistula thrombosis (5%) 

Constipation (5%) 

Frequency Not Defined 

Toxic epidermal necrolysis 

Stevens-Johnson syndrome 

Black Box Warning

Black Box Warning: 

The drug increases the risk of myocardial infarction, thrombosis, venous thromboembolism, tumor progression, and death. The patients undergoing clinical trials are prone to chronic kidney disease and cancer. 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 

Cautions 

• Uncontrolled hypertension 
• Thrombotic events  
• Pure red cell aplasia 
• Iron deficiency 
• Seizures 
• Pregnancy 
• Lactation 

Pregnancy / Lactation

Pregnancy consideration:  

The data available is insufficient to know about the usage during pregnancy. 

Breastfeeding warnings:  

No data are available. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology:  

epoetin beta/methoxy polyethylene glycol acts as a synthetic form of erythropoietin, a hormone produced naturally in the kidneys. It binds to and activates erythropoietin receptors on erythroid progenitor cells in the bone marrow, promoting their proliferation, differentiation, and maturation into red blood cells. Stimulating erythropoiesis increases red blood cell production, leading to an increase in hemoglobin levels and correction of anemia.

Pharmacodynamics: 

epoetin beta/methoxy polyethylene glycol helps regulate hemoglobin levels by stimulating of RBC production. An increase in the number of circulating red blood cells enhances the blood’s oxygen-carrying capacity, alleviating anemia symptoms and improving tissue oxygenation. 

Pharmacokinetics: 

Absorption 

The peak plasma time for subcutaneous is 72 hours 

The bioavailability is 62% 

The onset of action is 7-15 day after the initial dose 

Distribution 

The volume of distribution at a steady state is 61 ml/kg 

Metabolism 

The drug gets metabolized extensively in the liver. 

Elimination and Excretion 

The rate of total clearance is 0.4 mcg/kg for intravenous dose, and the half-life is 119 hours 

Adminstartion

Administration: 

The combination drug is administered through intravenous or subcutaneous route.

Patient Information Leaflet

Patient information leaflet 

Generic Name: epoetin beta/methoxy polyethylene glycol 

Why do we use epoetin beta/methoxy polyethylene glycol? 

The drug compound belongs to hematopoietic growth factors. It helps to cure the anemia caused due to chronic kidney disease.