NEORECORMON

What it is

NeoRecormon (epoetin beta rch) is a sterile, purified, stable recombinant human erythropoietin concentrate produced from genetically engineered Chinese hamster ovary cells. The active ingredient is a highly purified glycoprotein, identical in amino acid sequence to endogenous erythropoietin, with a mean molecular weight of approximately 30 kDa. It is supplied as a solution for injection in a colourless, clear to slightly opalescent form.

Approved indications

— Treatment of anaemia associated with chronic kidney disease (CKD) in patients on dialysis and symptomatic patients not yet undergoing dialysis. — Increasing the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood. — Prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks. — Treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate.

Dosing overview

Use the lowest dose of NeoRecormon that will gradually increase the haemoglobin concentration. NeoRecormon dosing regimens are different for each of the indications. For chronic kidney disease, the recommended starting dose for subcutaneous administration is 60 IU/kg body weight per week, administered as a single weekly injection or in up to 7 divided doses. For intravenous administration, the initial dose is 120 IU/kg body weight per week, administered in 3 divided doses. During maintenance, to maintain haemoglobin between 100–120 g/L, the dose is initially reduced to half of the previously administered amount. For autologous blood donation, the dose is 400–1600 IU/kg body weight per week intravenously or 300–1200 IU/kg body weight per week subcutaneously, administered in 2 divided doses, for a maximum of 4 weeks. For prevention of anaemia of prematurity, the solution is administered subcutaneously at a dose of 750 IU/kg body weight per week administered in 3 divided doses. The treatment should last for 6 weeks. For treatment of anaemia in patients with non-myeloid malignancies, the recommended initial dose is 450 IU/kg body weight per week, administered subcutaneously as a single weekly injection or in 3 to 7 divided doses. The maximum dose should not exceed 900 IU/kg body weight per week.

Key safety warnings

In some studies, use of erythropoiesis stimulating agents (ESAs) to treat anaemia in patients with cancer has been associated with increased mortality. ESAs should only be used to treat anaemia that has developed as a result of concomitantly administered chemotherapy, and only when blood transfusion is not considered appropriate. Haemoglobin levels should not exceed 120 g/L. In controlled clinical trials, ESAs increased the risk for death in oncology patients and for serious cardiovascular events in oncology and chronic kidney disease patients when administered to target a haemoglobin of greater than 120 g/L. There was an increased risk of serious arterial and venous thromboembolic events, including myocardial infarction, stroke, congestive heart failure and haemodialysis graft occlusion. To reduce cardiovascular risks, use the lowest dose of NeoRecormon that will gradually increase the haemoglobin concentration. The haemoglobin concentration should not exceed 120 g/L and the rate of haemoglobin increase should not exceed 10 g/L in a 2-week period. Patients with uncontrolled hypertension should not be treated with NeoRecormon. Blood pressure may rise during treatment of anaemia with NeoRecormon. Hypertensive encephalopathy and seizures have been observed. They require the immediate attention of a physician and intensive medical care. Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning sign. Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment. More severe cases have been observed with long acting epoetins.

Contraindications

NeoRecormon is contraindicated in patients with poorly controlled hypertension and in those with known hypersensitivity to the active substance or any of the excipients. In the indication of increasing the yield of autologous blood, NeoRecormon must not be used in patients who, in the month preceding treatment, have suffered a myocardial infarction or stroke, patients with unstable angina pectoris, or patients who are at risk of deep venous thrombosis such as those with a history of venous thromboembolic disease.

PBS listing

NeoRecormon is listed on the PBS in six strengths: 2,000 units, 3,000 units, 4,000 units, 5,000 units, 6,000 units and 10,000 units in pre-filled syringes. All presentations are listed with streamlined restrictions. Ex-manufacturer prices range from A$162.80 for 2,000 units to A$620.68 for 10,000 units.

Regulatory history

NeoRecormon was first registered on the ARTG on 9 January 2006, with six strengths (2,000 IU, 3,000 IU, 4,000 IU, 5,000 IU, 6,000 IU and 10,000 IU pre-filled syringes) registered under licence category RE. An indication for treatment of anaemia in patients with non-myeloid malignancies was added by revision on 28 February 2020.