methoxy polyethylene glycol-epoetin beta: clinical use

Prescribing considerations

• Initiate under the supervision of a clinician experienced in renal impairment.
• Confirm that anaemia is symptomatic and associated with chronic kidney disease; use for cancer-related or chemotherapy-induced anaemia is not established or licensed.
• Investigate iron, folate or vitamin B12 deficiency, inflammation, infection, bleeding, haemolysis and marrow disease when response is inadequate.
• Higher haemoglobin targets and high cumulative ESA exposure are associated with increased cardiovascular, cerebrovascular and thrombotic risk.
• Record the product name and batch number to maintain biological-medicine traceability.

Contraindications and cautions

• Hypersensitivity to the active substance or an excipient.
• Uncontrolled hypertension.

Monitoring

• Haemoglobin response and rate of change.
• Blood pressure before and throughout treatment.
• Iron status before and during treatment; correct deficiencies that may limit erythropoiesis.
• Consider reticulocytes and evaluation for anti-erythropoietin antibody-mediated pure red cell aplasia if haemoglobin falls unexpectedly.
• Clinical evidence of thrombosis, severe skin reactions or hypersensitivity.

Clinical pharmacology

A recombinant, pegylated continuous erythropoietin receptor activator. It stimulates erythroid progenitor cells and has a prolonged elimination half-life; haemodialysis does not materially alter its pharmacokinetics.

Formulation and product differences

• Ready-to-use solution in a pre-filled syringe supplied with a needle.
• Sterile, preservative-free and intended for one injection only; partial administration is not supported.
• The solution must not be mixed with other medicinal products.
• Store refrigerated, do not freeze and retain in the outer carton to protect from light.
• Essentially sodium-free.