What is MIRCERA®?
MIRCERA® is a Continuous Erythropoetin Receptor Activator (C.E.R.A.) indicated for:
the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients.
the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA.
Due to its distinct mode of action, MIRCERA® is hypothesized to closely mimic the homeostatic maintenance of erythrocyte production under normal physiological conditions. This mechanism, combined with a prolonged half-life, supports the correction of anaemia and the stable maintenance of haemoglobin (Hb) levels at extended, once-monthly administration intervals.1 This allows correction of anaemia and stable control of Haemoglobin (Hb) levels at extended, once monthly administration intervals.1
1) Jarsch M et al. Pharmacology. 2008;81(1):63–9.
How to manage anaemia in patients with CKD
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary.
MIRCERA® should be administered either subcutaneously or intravenously in order to increase Hb to not greater than 12 g/dl. SC use is preferable in patients who are not receiving HD to avoid puncture of peripheral veins.
Due to intra-patient variability, occasional individual Hb values for a patient above and below the desired Hb level may be observed. Hb variability should be addressed through dose management, with consideration for the Hb target range of 10 g/dl to 12 g/dl (how to start Mircera for anaemia correction / how to change to Mircera from other ESAs).
Patients should be monitored closely to ensure that the lowest approved effective dose of treatment is used to provide adequate control of the symptoms of anaemia whilst maintaining a Hb concentration below or at 12 g/dl. A sustained Hb level of greater than 12 g/dl should be avoided.
Caution should be exercised with escalation of treatment doses in patients with chronic renal failure. In patients with a poor Hb response to treatment, alternative explanations for the poor response should be considered.
It is recommended that Hb is monitored every two weeks until stabilised and periodically thereafter.
2) Del Vecchio L, et al. Nephrol Dial Transplant. 2026;Epub ahead of print:gfag014.
How to start treatment with MIRCERA® for correction of renal anaemia in adult patients
The recommended starting dose in adult patients not on dialysis is
1.2 microgram/kg body weight, administered once every month as a single subcutaneous injection.
Alternatively, a starting dose of 0.6 microgram/kg bodyweight may be administered once every two weeks as a single intravenous or subcutaneous injection in patients on dialysis or not on dialysis.
Patients treated once every two weeks whose Hb concentration is above 10 g/dl may receive MIRCERA® administered once-monthly using the dose equal to twice the previous once-every-two-week dose.
Dose adjustment:
- Use the lowest approved dose of MIRCERA® to maintain Hb target range of 10–12 g/dl and avoid a sustained Hb level above 12 g/dl.
- The dose may be increased by approximately 25% of the previous dose if the rate of rise in Hb is less than 1.0 g/dl over a month. Further increases of approximately 25% may be made at monthly intervals until the individual target Hb level is obtained.
- If the rate of rise in Hb is greater than 2 g/dl in one month or if the Hb level is increasing and approaching 12 g/dl, the dose is to be reduced by approximately 25%.
- If the Hb level continues to increase, therapy should be interrupted until the Hb level begins to decrease and restarted at a dose approximately 25% below the previously administered dose.
- Dose adjustments should not be made more frequently than once a month.
How to change to MIRCERA® from other erythropoiesis stimulating agents in adult patients
Adult patients currently treated with an Epoetin or Darbepoetin alfa can be switched to MIRCERA® administered once a month as a single intravenous or subcutaneous injection.
The starting dose of MIRCERA® is based on the calculated previous weekly dose of darbepoetin alfa or epoetin at the time of substitution. The first injection should start at the next scheduled dose of the previously administered darbepoetin alfa or epoetin.
| Previous weekly darbepoetin alfa intravenous or subcutaneous dose (microgram/week) | Previous weekly epoetin intravenous or subcutaneous dose (IU/week) | Monthly MIRCERA® intravenous or subcutaneous dose (microgram/once monthly) |
| <40 | <8000 | 120 |
| 40-80 | 8000 - 16000 | 200 |
| >80 | >16000 | 360 |
Dose adjustment:
If a dose adjustment is required to maintain the target Hb concentration above 10 g/dl, the monthly dose may be increased by approximately 25%.
If the rate of rise in Hb is greater than 2 g/dl over a month or if the haemoglobin level is increasing and approaching 12 g/dl, the dose is to be reduced by approximately 25%. If the Hb level continues to increase, therapy should be interrupted until the Hb level begins to decrease, and therapy restarted at a dose approximately 25% below the previously administered dose.
Dose adjustments should not be made more frequently than once a month.
How to change to MIRCERA® from other erythropoesis stimulating agents in paediatric patients
Paediatric patients from the age of 3 months to less than 18 years, whose Hb level has been stabilised by treatment with an erythropoiesis stimulating agent can be converted to MIRCERA® administered once every 4 weeks as an IV or SC injection, but keeping the same administration route.
The starting dose of MIRCERA® is calculated based on the total weekly ESA dose at the time of conversion.
| Previous weekly darbepoetin alfa dose (mcg/week) | Previous weekly epoetin dose (IU/week) | Every 4-week MIRCERA® dose (mcg) |
| 9 - <12 | 2000 - <2700 | 30 |
| 12- <15 | 2700 - <3500 | 50 |
| 15 - <24 | 3500 - <5500 | 75 |
| 24 - <30 | 5500 - <6500 | 100 |
| 30 - <35 | 6500 - <8000 | 120 |
| 35 - <47 | 8000 - <10000 | 150 |
| 47- <60 | 10000 - <13000 | 200 |
| 60 - <90 | 13000 - <20000 | 250 |
| ≥90 | ≥20000 | 360 |
Pre-filled syringes are not designed for administration of partial doses. Due to the available dose strengths of pre-filled syringes, paediatric patients with an ESA dose of <9 microgram/week (darbepoetin alfa) or <2000 IU/week of epoetin, should not be switched to MIRCERA®.
Dose adjustment:
If a dose adjustment is required to maintain the target Hb concentration above 10 g/dl, the 4 weekly dose may be adjusted by approximately 25%.
If the rise in Hb is greater than 1 g/dl (0.62 mmol/l) over 4 weeks or the Hb level is increasing and approaching 12 g/dl (7.45 mmol/l), the MIRCERA®. dose is to be reduced by approximately 25%.
If the Hb level continues to increase following dose reduction, therapy is to be interrupted until the Hb level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Dose adjustments should not be made more often than once every 4 weeks.
How to use the MIRCERA®
Pre-filled Syringe
Store in a refrigerator (2°C – 8°C). Once removed from the refrigerator MIRCERA® must be used within one month.
MIRCERA® Safety Information
Contraindications:
Hypersensitivity to any ingredient. Uncontrolled hypertension.
Precautions & Warnings:
Iron status should be evaluated for all patients prior to and during treatment; supplementary iron therapy is recommended for patients with serum ferritin <100 microgram/l or transferrin saturation <20%.
Failure to respond to treatment should prompt a search for causative factors such as deficiencies in iron, folic acid, or vitamin B12, intercurrent infections, inflammation, or occult blood loss. If a sudden drop in haemoglobin occurs associated with reticulocytopenia and anti-erythropoietin antibodies (AEAB), examine bone marrow for the diagnosis of Pure Red Cell Aplasia (PRCA). In case PRCA is diagnosed, treatment must be discontinued and patients should not be switched to any other ESA. Patients suspected or confirmed to have antibodies to erythropoietin should not be switched to MIRCERA®.
In clinical trials, an increased risk of death and serious cardiovascular or cerebrovascular events, including stroke, was observed when ESAs were administered to target Hb >12 g/dl. Caution should be exercised with dose escalation in patients with chronic renal failure as high cumulative doses may be associated with increased mortality and cardiovascular risks. Monitor blood pressure; if hypertension is difficult to control by medical treatment or diet, reduce or withhold dose.
Caution is required in patients with haemoglobinopathies, seizures, bleeding, recent bleeding requiring transfusion, or platelets >500 x 10⁹/l.
Pediatric patients, particularly those under 1 year of age, should be carefully evaluated before switching and must have stabilized haemoglobin levels prior to conversion. Patients receiving very low doses of their current ESA (<9 microgram/week darbepoetin alfa or <2000 IU/week epoetin) should not be switched to MIRCERA®, as the lowest available dose strength is 30 micrograms and partial doses are not recommended.
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; more severe cases have been observed with long-acting epoetins. MIRCERA® should be withdrawn immediately if signs of these reactions appear.
ESAs may stimulate growth of any type of malignancy; MIRCERA® is not approved for the treatment of anaemia in patients with cancer. Epoetins are not approved for the management of anaemia associated with hepatitis C.
Misuse of MIRCERA® by healthy people may lead to an excessive increase in Hb, which may be associated with life-threatening cardiovascular complications. To improve traceability, the name and batch number of the administered product should be clearly recorded.
For a comprehensive overview of all safety considerations, please refer to the full Summary of Product Characteristics (SmPC), specifically Section 4.4, for complete Special Warnings and Precautions for Use.
Undesirable effects:
Common: hypertension. Uncommon: headache, vascular access site thrombosis, thrombosis, thrombocytopenia. Rare: hypersensitivity, hypertensive encephalopathy, pulmonary embolism, hot flush, rash. Frequency not known: pure red cell aplasia (PRCA), anaphylactic reaction, Stevens-Johnson syndrome/toxic epidermal necrolysis During treatment, a slight decrease in platelet counts remaining within the normal range was observed in clinical trials ; however, cases of thrombocytopenia have been reported in the post-marketing setting. The safety profile in paediatric patients is overall consistent with that known for the adult population.
For a comprehensive overview of all undesirable effects, please refer to the full Summary of Product Characteristics (SmPC), specifically Section 4.8 Undesirable effects.
Adverse events should be reported to F. Hoffmann- La Roche Ltd.
