Epoetin beta

Summary

Epoetin beta is a recombinant human erythropoietin glycoprotein produced in Chinese hamster ovary (CHO) cells. It is approved for the treatment of anemia associated with chronic kidney disease (CKD), chemotherapy-induced anemia in cancer patients, and anemia related to zidovudine therapy in HIV-infected patients. It reduces the need for red blood cell transfusions.

Mechanism of Action

Binds to erythropoietin receptors on erythroid progenitor cells in bone marrow, activating JAK2/STAT5 signaling pathways to stimulate proliferation, differentiation, and survival of red blood cell precursors, thereby increasing red blood cell production and hemoglobin levels.

Routes of Administration

Goals & Uses

• Treatment of anemia in chronic kidney diseaseHematology / NephrologyHigh
• Anemia in premature neonatesNeonatologyModerate
• Reduction of allogeneic blood transfusionsPerioperative MedicineModerate
• Anemia associated with myelodysplastic syndromesHematology / OncologyModerate
• Chemotherapy-induced anemiaOncology / HematologyHigh

Contraindications

• Thrombotic risk or recent thrombotic eventCardiovascular / HematologicalModerate
• Cancer patients with curative intent receiving chemotherapyOncologyHigh
• Hypersensitivity to epoetin beta or excipientsAllergic / ImmunologicalHigh
• Uncontrolled hypertensionCardiovascularHigh
• Pure red cell aplasia (PRCA) due to prior ESA therapyImmunologicalHigh

Adverse Effects

• Flu-like symptomsSystemic/ImmunologicalCommon
• HypertensionCardiovascularCommonHigh blood pressure
• Injection site reactionsLocalCommon
• SeizuresNeurologicalRare
• Pure red cell aplasia (PRCA)Immunological / HematologicalRare
• Thrombotic/thromboembolic eventsCardiovascular / HematologicalUncommon

Drug Interactions

• Antihypertensive agentsModerate
• CyclosporineModerate
• Iron supplementsModerate
• ACE inhibitors / Angiotensin receptor blockersLow

Population Constraints

• PregnancyReproductive SafetyRelative
• Patients with hemoglobin >10 g/dL at initiationHematologicalRelative
• Pediatric patientsAgeRelative
• LactationReproductiveRelative
• Cancer patients not receiving chemotherapyOncologicalRelative

Regulatory Status

• European UnionApprovedApproved: Anemia associated with chronic renal failure (dialysis and pre-dialysis patients), Prevention and treatment of anemia in adult cancer patients on chemotherapy, Reduction of autologous blood transfusions in surgical patients, Treatment of anemia in premature neonatesMarketed as NeoRecormon by Roche. Centrally authorized by EMA. Subject to risk management plan including monitoring for PRCA.
• United StatesUnapprovedEpoetin beta is not separately approved in the US. Epoetin alfa (Epogen, Procrit) and biosimilars are used. Methoxy polyethylene glycol-epoetin beta (Mircera) is a distinct, separately approved long-acting product.
• United KingdomApprovedApproved: Anemia in chronic renal failure, Chemotherapy-induced anemia in adult cancer patients, Reduction of allogenic blood transfusion in elective surgeryRetained EU approval status post-Brexit via MHRA. Marketed as NeoRecormon.

Approved in the EU and many other jurisdictions as NeoRecormon (Roche). Not separately approved in the US under this name; epoetin alfa (Epogen/Procrit) is the predominant US product. Subject to REMS-equivalent risk management programs in EU due to pure red cell aplasia (PRCA) risk.

Evidence & Sources

No sources recorded yet.