Methoxy polyethylene glycol-epoetin beta
Also known as: C.E.R.A., CERA, Continuous Erythropoietin Receptor Activator, Methoxy PEG‑Epoetin beta, Mircera, PEG-epoetin beta
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Summary
Methoxy polyethylene glycol-epoetin beta (brand name Mircera) is a pegylated recombinant human erythropoietin used as a long‑acting therapy for anemia in chronic kidney disease.
Mechanism of Action
Binds to the erythropoietin receptor on erythroid progenitor cells, activating the JAK2/STAT5 signaling cascade and promoting red blood cell production.
Routes of Administration
Goals & Uses
- Treatment of anemia in chronic kidney disease (non-dialysis)Hematology / NephrologyHigh
- Reduction of transfusion requirementsHematologyHigh
- Treatment of anemia in chronic kidney disease (dialysis)Hematology / NephrologyHigh
- Reduce need for blood transfusionsTherapeuticHigh
- Hemoglobin stabilization in CKDHematologyHigh
- Increase hemoglobin levelsTherapeuticHigh
Contraindications
- Active malignancyOncologyModerateUse caution or avoid depending on agent and context
- Pure red cell aplasia (PRCA)HematologicHigh
- Use as a substitute for red blood cell transfusion in patients needing immediate correction of anemiaClinicalHigh
- Known hypersensitivity to the productImmunologicHigh
- Hypersensitivity to methoxy polyethylene glycol-epoetin beta or excipientsImmunologicHigh
- Uncontrolled hypertensionCardiovascularHigh
- Pure red cell aplasia (PRCA) due to prior ESA therapyImmunologicalHigh
Adverse Effects
- Flu‑like symptomsSystemicUncommon
- HypertensionCardiovascularCommonHigh blood pressure
- Injection site reactionsLocalCommon
- Hypersensitivity/anaphylaxisImmunologicalRare
- HeadacheNeurologicCommonPain in the head or upper neck
- Thromboembolic eventsCardiovascularRare
- Injection‑site reactionsLocalCommon
- Pure red cell aplasia (PRCA)Immunological / HematologicalRare
- Thromboembolic events (including stroke, MI, DVT, PE)CardiovascularUncommon
Drug Interactions
- Antihypertensive agentsLow
- CyclosporineModerate
- Iron deficiencyModerate
- Iron supplementsLow
- Concurrent use of other ESAsHigh
Population Constraints
- PregnancyReproductive SafetyRelative
- Patients with active malignancyOncologyRelative
- Pediatric patientsAgeRelative
- Patients with history of cardiovascular disease or strokeCardiovascularRelative
- Elderly patientsAgeRelative
- Pediatric patients <1 yearAgeRelative
- Pregnant womenReproductiveRelative
Regulatory Status
- European UnionApprovedApproved: Anemia in chronic kidney disease (dialysis and non‑dialysis)EMA approval 2007.
- United StatesApprovedApproved: Anemia in chronic kidney disease (dialysis and non‑dialysis)Approved by FDA in 2007 as Mircera.
- United KingdomApprovedApproved: Anemia in chronic kidney disease (dialysis and non‑dialysis)MHRA approval aligned with EU.
Approved in the United States (2007), European Union (2007) and United Kingdom (2007) as Mircera for anemia associated with chronic kidney disease, both dialysis‑dependent and non‑dialysis patients.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Methoxy polyethylene glycol-epoetin beta?
Methoxy polyethylene glycol-epoetin beta (brand name Mircera) is a pegylated recombinant human erythropoietin used as a long‑acting therapy for anemia in chronic kidney disease.
What is Methoxy polyethylene glycol-epoetin beta used for?
Methoxy polyethylene glycol-epoetin beta is educationally associated with: Treatment of anemia in chronic kidney disease (non-dialysis), Reduction of transfusion requirements, Treatment of anemia in chronic kidney disease (dialysis), Reduce need for blood transfusions, Hemoglobin stabilization in CKD, Increase hemoglobin levels. Educational only — not medical advice.
How is Methoxy polyethylene glycol-epoetin beta administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Methoxy polyethylene glycol-epoetin beta?
Reported adverse effects include: Flu‑like symptoms, Hypertension, Injection site reactions, Hypersensitivity/anaphylaxis, Headache, Thromboembolic events, Injection‑site reactions, Pure red cell aplasia (PRCA), Thromboembolic events (including stroke, MI, DVT, PE). This list is not exhaustive — consult a qualified clinician.
Who should avoid Methoxy polyethylene glycol-epoetin beta?
Recorded contraindications: Active malignancy, Pure red cell aplasia (PRCA), Use as a substitute for red blood cell transfusion in patients needing immediate correction of anemia, Known hypersensitivity to the product, Hypersensitivity to methoxy polyethylene glycol-epoetin beta or excipients, Uncontrolled hypertension, Pure red cell aplasia (PRCA) due to prior ESA therapy. Consult a qualified clinician before use.