Methoxy polyethylene glycol-epoetin beta

Erythropoiesis Stimulating Agent (ESA); PEGylated ErythropoietinRx: PrescriptionCompound: Approved

Also known as: C.E.R.A., CERA, Continuous Erythropoietin Receptor Activator, Mircera, PEG-epoetin beta

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Methoxy polyethylene glycol-epoetin beta (Mircera) is a continuous erythropoietin receptor activator (CERA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adults and pediatric patients. Its unique PEGylation provides a prolonged half-life (~130–140 hours), enabling monthly subcutaneous or intravenous dosing. It is approved in the EU, US, and many other jurisdictions.

Mechanism of Action

Activates the erythropoietin receptor on erythroid progenitor cells, stimulating proliferation, differentiation, and survival of red blood cell precursors, thereby increasing red blood cell production and hemoglobin levels. The methoxy polyethylene glycol (PEG) moiety extends the half-life significantly compared to native epoetin, allowing once-monthly dosing.

Routes of Administration

IntravenousSubcutaneous

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
  • Hemoglobin stabilization in CKDHematologyHigh

Contraindications

  • Use as a substitute for red blood cell transfusion in patients needing immediate correction of anemiaClinicalHigh
  • Hypersensitivity to methoxy polyethylene glycol-epoetin beta or excipientsImmunologicHigh
  • Uncontrolled hypertensionCardiovascularHigh
  • Pure red cell aplasia (PRCA) due to prior ESA therapyImmunologicalHigh

Adverse Effects

  • HypertensionCardiovascularCommonHigh blood pressure
  • Injection site reactionsLocalCommon
  • Hypersensitivity/anaphylaxisImmunologicalRare
  • HeadacheNeurologicCommonPain in the head or upper neck
  • Pure red cell aplasia (PRCA)Immunological / HematologicalRare
  • Thromboembolic events (including stroke, MI, DVT, PE)CardiovascularUncommon

Drug Interactions

  • Antihypertensive agentsModerate
  • CyclosporineModerate
  • Iron supplementsLow

Population Constraints

  • PregnancyReproductive SafetyRelative
  • Patients with active malignancyOncologyRelative
  • Patients with history of cardiovascular disease or strokeCardiovascularRelative
  • Pediatric patients <1 yearAgeRelative

Regulatory Status

  • European UnionApprovedApproved: Treatment of symptomatic anemia associated with chronic kidney disease in adult and pediatric patientsEMA approval granted November 2007; centralized procedure. Marketing authorization held by Roche Registration GmbH.
  • United StatesApprovedApproved: Treatment of anemia associated with chronic kidney disease in adults on dialysis, Treatment of anemia associated with chronic kidney disease in adults not on dialysisFDA-approved in 2007; marketed as Mircera by Hoffmann-La Roche. Carries ESA class boxed warning.
  • United KingdomApprovedApproved: Treatment of symptomatic anemia associated with chronic kidney disease in adult and pediatric patientsRetained approval post-Brexit via MHRA; equivalent indications to EMA approval.

Approved by the EMA in 2007 and the FDA in 2007 (US approval; marketed as Mircera by Roche/Vifor Pharma). A biosimilar development landscape exists. Boxed warning in the US for increased risk of death, serious cardiovascular events, thromboembolic events, stroke, and tumor progression or recurrence when hemoglobin targets exceed 11 g/dL in cancer patients (though Mircera is not indicated for cancer-related anemia).

Evidence & Sources

No sources recorded yet.

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