NOVICRIT

What it is

Novicrit Solution for Injection contains epoetin lambda (rch) as its active ingredient. Epoetin lambda (rch) is purified from a Chinese hamster ovary (CHO) cell line into which the gene coding for human erythropoietin has been inserted. Epoetin lambda (rch) is indistinguishable from human erythropoietin in biological activity and immunological reactivity. Novicrit is supplied in a pre-filled syringe as a clear, colourless solution for injection.

Approved indications

— Treatment of patients with symptomatic or transfusion-requiring anaemia associated with chronic renal failure to improve quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions. — Treatment of anaemia in patients with nonmyeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. — Treatment in adult patients with mild to moderate anaemia (haemoglobin greater than 100 to ≤130 g/L) scheduled for elective surgery with expected moderate blood loss (two to four units or 900 to 1,800 mL) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. — Augmentation of autologous blood collection and limitation of the decline in haemoglobin in anaemic adult patients scheduled for major elective surgery and who are not expected to predeposit their complete perioperative blood needs.

Dosing overview

During therapy, haematological parameters should be monitored regularly. Doses must be individualised to ensure that haemoglobin is maintained at an appropriate level for each patient. For chronic renal failure patients, treatment involves two phases. The correction phase starts with an initial dose of 50 IU/kg bodyweight three times a week. If haemoglobin does not increase by 10 g/L after one month, dosage may be raised to 75 IU/kg three times weekly. Further increments should be at 25 IU/kg three times weekly at monthly intervals to achieve haemoglobin not to exceed 120 g/L. This level should not be exceeded in patients with chronic renal failure. Maximum dose should not exceed 3 × 200 IU/kg per week. The maintenance phase requires dose adjustment to maintain haemoglobin not to exceed 120 g/L. The maintenance dose should be individualised for each chronic renal failure patient. The recommended total weekly dose is between 75 and 300 IU/kg. For adult patients with cancer, treatment should not be commenced unless haemoglobin falls below 100 to 110 g/L. The target haemoglobin concentration should be up to 120 g/L in men and women and it should not be exceeded. The initial dose is 150 IU/kg given subcutaneously three times weekly. If haemoglobin has increased by at least 10 g/L or reticulocyte count has increased ≥40,000 cells/microliter above baseline after four weeks, the dose should remain at 150 IU/kg. If haemoglobin increase is <10 g/L and reticulocyte count increase is <40,000 cells/microliter, increase dose to 300 IU/kg. If after an additional four weeks at 300 IU/kg, haemoglobin has increased ≥10 g/L or reticulocyte count has increased ≥40,000 cells/microliter the dose should remain at 300 IU/kg. However, if haemoglobin increase is <10 g/L and reticulocyte count increase is <40,000 cells/microliter, response is unlikely and treatment should be discontinued. For adult patients scheduled for elective surgery, the recommended dose regimen is 600 IU/kg Novicrit given weekly for three weeks (days −21, −14, and −7) prior to surgery and on the day of surgery.

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. An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs such as epoetin lambda (rch). These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, haemodialysis graft occlusion, myocardial ischaemia and myocardial infarction. Epoetin lambda (rch) and other erythropoiesis-stimulating agents increased the risk for death and for serious cardiovascular events in controlled trials 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. A rate of haemoglobin rise of greater than 10 g/L over 2 weeks may also contribute to these risks. Patients with uncontrolled hypertension should not be treated with epoetin lambda (rch); blood pressure should be controlled adequately before initiation of therapy. Blood pressure may rise during treatment of anaemia with epoetin lambda (rch). Hypertensive encephalopathy and seizures have been observed. Special care should be taken to closely monitor and control blood pressure in patients treated with epoetin lambda (rch). In chronic renal failure patients, antibody-mediated pure red cell aplasia (PRCA) (erythroblastopenia) has been rarely reported after months to years of treatment with erythropoietins. Cases also have been rarely reported in patients with hepatitis C treated with interferon and ribavirin, when ESAs are used concomitantly. ESAs are not approved in the management of anaemia associated with hepatitis C. 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. At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions.

Contraindications

Novicrit is contraindicated in patients with uncontrolled hypertension, known sensitivity to mammalian cell-derived products, hypersensitivity to the active substance or to any of the excipients, and in patients scheduled for elective surgery who are not participating in an autologous blood predeposit program and who have severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident. Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis or treatment are contraindicated. Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive epoetin lambda (rch) or any other erythropoietin.

PBS listing

Novicrit is listed on the PBS in strengths of 1,000 units, 2,000 units, 3,000 units, 4,000 units, 5,000 units, 6,000 units, 8,000 units and 10,000 units as pre-filled syringes, each with 2 PBS items. The restriction type is streamlined. Ex-manufacturer prices range from A$83.60 for the 1,000 unit strength to A$589.71 for the 10,000 unit strength as of the latest schedule from 2026-05-01.

Regulatory history

Novicrit epoetin lambda (rch) was first registered on the ARTG on 2010-01-27 across ten strengths (1,000 IU to 10,000 IU), all in pre-filled syringe formulation under licence category RE. In July 2017, the PBAC recommended a change to remove the note restricting epoetin lambda to intravenous administration only, allowing for subcutaneous administration in the treatment of anaemia associated with intrinsic renal disease.