MIRCERA

What it is

Mircera is methoxy polyethylene glycol-epoetin beta. It is a solution for injection in pre-filled syringe. Mircera is a chemically synthesised Erythropoiesis Stimulating Agent with a much longer half-life than erythropoietin. Mircera has a longer half-life than erythropoietin, which enables it to be administered in a once monthly dosing regimen.

Approved indications

— Treatment of anaemia associated with chronic kidney disease.

Dosing overview

Use the lowest dose of Mircera that will gradually increase the haemoglobin concentration. Mircera is administered less frequently than other erythropoiesis stimulating agents due to the longer elimination half-life. For patients not currently treated with an erythropoiesis stimulating agent, the recommended starting dose for those not on dialysis is 1.2 µg/kg body weight administered once every month as a single subcutaneous injection, or alternatively 0.6 µg/kg body weight once every two weeks as a single intravenous or subcutaneous injection. For patients on dialysis, the recommended starting dose is 0.6 µg/kg body weight once every two weeks as a single intravenous or subcutaneous injection. The dose may be increased by approximately 25% of the previous dose if the rate of rise in haemoglobin is less than 10 g/L over a month, with further increases of approximately 25% made at monthly intervals until the individual target haemoglobin level is obtained. The dose for each patient should be adjusted so that the haemoglobin level does not exceed 120 g/L.

Key safety warnings

Cardiovascular and thrombotic events such as myocardial ischaemia and infarction, cerebrovascular haemorrhage and infarction, and thromboembolism have been reported in patients receiving erythropoiesis stimulating agents. In controlled clinical trials, erythropoiesis stimulating agents 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, with an increased risk of serious arterial and venous thromboembolic events. A rate of haemoglobin rise of greater than 10 g/L over 2 weeks may also contribute to these risks. To reduce cardiovascular risks, use the lowest dose of Mircera 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. Serious allergic reactions including pruritis and rash have been reported in patients treated with Mircera. If a serious allergic or anaphylactic reaction occurs, treatment should be immediately discontinued and appropriate therapy should be administered. Patients with uncontrolled hypertension should not be treated with Mircera; blood pressure should be adequately controlled before initiation of therapy. Blood pressure may rise during treatment of anaemia with Mircera. Hypertensive encephalopathy and seizures have been observed in patients treated with Mircera. Special care should be taken to closely monitor and control blood pressure in patients treated with Mircera. Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoiesis stimulating agent therapy including Mircera. Patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to Mircera. If anti-erythropoietin antibody-mediated pure red cell aplasia develops whilst on Mircera, therapy must be discontinued and patients should not be switched to another erythropoiesis stimulating agent. Severe cutaneous adverse reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be life-threatening or fatal, have been reported in association with epoetin treatment, with more severe cases 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. If signs and symptoms suggestive of these reactions appear, Mircera should be withdrawn immediately and an alternative treatment considered.

Contraindications

Mircera is contraindicated in patients with uncontrolled hypertension and in those with known hypersensitivity to the active substance or any of the excipients.

PBS listing

Mircera is listed on the PBS in the following strengths with streamlined restriction: 30 micrograms, 50 micrograms, 75 micrograms, 100 micrograms, 120 micrograms, 200 micrograms, and 360 micrograms in pre-filled syringes. Each strength has 2 PBS items. Ex-manufacturer prices range from A$110.50 for the 30 microgram strength to A$995.65 for the 360 microgram strength.

Regulatory history

Mircera was first listed on the ARTG on 28 July 2009 with nine registered variants across strengths of 30, 50, 75, 100, 120, 150, 200, 250, and 360 micrograms. The product information was first approved on 9 May 2011.