epoetin zeta: clinical use

Prescribing considerations

• Confirm the indication and investigate reversible causes of anaemia, including iron, folate or vitamin B12 deficiency, inflammation, blood loss and haemolysis.
• Ensure adequate iron availability and investigate an unexpectedly poor response.
• Balance benefit against thrombotic and cardiovascular risk, particularly in cancer, surgery or patients with previous vascular events.
• Prescribe and record biological medicines by brand and batch for traceability.
• Switch between erythropoiesis-stimulating agents only under appropriate clinical supervision.
• Use caution with seizure disorders, poorly controlled hypertension, chronic liver failure, porphyria and thrombotic risk factors.

Contraindications and cautions

• Hypersensitivity to epoetin zeta or an excipient.
• Uncontrolled hypertension.
• Pure red cell aplasia following any erythropoietin treatment.
• For relevant orthopaedic-surgery use: severe coronary, peripheral arterial, carotid or cerebral vascular disease, recent myocardial infarction or stroke, or inability to receive adequate antithrombotic prophylaxis.
• Applicable contraindications to autologous blood-predonation programmes.

Monitoring

• Blood pressure before and throughout treatment.
• Haemoglobin and the rate and consistency of response.
• Iron stores and other correctable causes of inadequate response.
• Platelet count, particularly during early treatment.
• Renal patients: electrolytes, dialysis access and circuit patency where relevant.
• Unexpected haemoglobin decline: reticulocytes, anti-erythropoietin antibodies and assessment for pure red cell aplasia.

Clinical pharmacology

Epoetin zeta is recombinant human erythropoietin produced in Chinese hamster ovary cells. It activates erythropoietin-receptor signalling on erythroid precursors, reducing apoptosis and stimulating red-cell production. Subcutaneous absorption is slower and less complete than intravenous administration.

Formulation and product differences

• The selected product is a clear, colourless, single-use solution in a pre-filled syringe with a fixed needle.
• Syringes may have no safety device, a passive needle guard or a needle-trap device; administration technique differs between devices.
• The formulation contains phenylalanine and polysorbate 20 and is essentially sodium-free.
• Keep refrigerated and protected from light; limited temporary room-temperature storage is permitted under the product conditions. Do not freeze or shake.

Injection

Route: Parenteral

Strengths: 1000 units/0.3 mL, 2000 units/0.6 mL, 3000 units/0.9 mL, 4000 units/0.4 mL, 5000 units/0.5 mL, 6000 units/0.6 mL, 8000 units/0.8 mL, 10000 units/1 mL, 20000 units/0.5 mL, 30000 units/0.75 mL, 40000 units/1 mL