darbepoetin alfa: clinical use

Prescribing considerations

• Treatment should be initiated by clinicians experienced in the licensed indication.
• For cancer-associated anaemia, assess tumour type and stage, thrombotic risk, prognosis, treatment setting and patient preference; transfusion may be preferable in some circumstances.
• Evaluate and correct reversible causes of poor response, including deficiencies of iron, folate or vitamin B12, inflammation, infection, blood loss, haemolysis or marrow disease.
• Record the administered ESA brand to support traceability.

Contraindications and cautions

• Hypersensitivity to darbepoetin alfa or an excipient.
• Poorly controlled hypertension.
• Use caution with controlled hypertension, previous thrombosis, epilepsy, sickle cell anaemia, liver disease or latex allergy.
• Do not restart after darbepoetin-associated Stevens–Johnson syndrome or toxic epidermal necrolysis. Suspected antibody-mediated pure red cell aplasia requires withdrawal and specialist investigation.

Monitoring

• Monitor haemoglobin response and avoid increases beyond that needed to control anaemia symptoms and reduce transfusion need.
• Check blood pressure, particularly during treatment initiation.
• Assess iron status before and during treatment; monitor for other nutritional or clinical causes of inadequate response.
• Consider potassium monitoring in chronic renal failure. In cancer patients, monitor platelets and thromboembolic risk.
• Investigate a paradoxical haemoglobin fall with reticulocytopenia for pure red cell aplasia and anti-erythropoietin antibodies.

Clinical pharmacology

A hyperglycosylated recombinant erythropoietin analogue with selective erythropoietin-receptor activity. Increased carbohydrate content prolongs terminal half-life relative to conventional recombinant human erythropoietin.

Formulation and product differences

• The pre-filled pen is a ready-to-use, single-use device for subcutaneous administration only.
• The pre-filled syringe is a single-use presentation that may be administered subcutaneously or intravenously where authorised and appropriate.
• Needle caps contain a natural-rubber latex derivative. The solution is sterile, unpreserved and should not be shaken or mixed with other medicines.

Injection

Route: Parenteral

Strengths: 20 micrograms, 40 micrograms, 60 micrograms, 80 micrograms, 100 micrograms, 150 micrograms, 300 micrograms, 500 micrograms