Presentation and Status in Health Basket
50 mcg/0.3 ml
75 mcg/0.3 ml
100 mcg/0.3 ml
150 mcg/0.3 ml
200 mcg/0.3 ml
360 mcg/0.6 ml
Treatment of symptomatic anaemia in adult chronic kidney disease patients: 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 haemoglobin to not greater than 12 g/dl (7.45 mmol/l). Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins. Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l). A sustained haemoglobin level of greater than 12 g/dl (7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.45 mmol/l) are observed are described below. A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four-week period should be avoided. If it occurs, appropriate dose adjustment should be made as provided. Patients should be monitored closely to ensure that the lowest approved dose is used to provide adequate control of the symptoms of anaemia. It is recommended that haemoglobin is monitored every two weeks until stabilized and periodically thereafter.
Patients not currently treated with an erythropoiesis stimulating agent (ESA): In order to increase haemoglobin levels to greater than 10 g/dl (6.21 mmol/l), the recommended starting dose in 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. The dose may be increased by approximately 25% of the previous dose if the rate of rise in haemoglobin is less than 1.0 g/dl (0.621 mmol/l) over a month. Further increases of approximately 25% may be made at monthly intervals until the individual target haemoglobin level is obtained. If the rate of rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) in one month or if the haemoglobin level is increasing and approaching 12 g/dl (7.45 mmol/l), the dose is to be reduced by approximately 25%. If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose. After dose interruption a haemoglobin decrease of approximately 0.35 g/dl (0.22 mmol/l) per week is expected. Dose adjustments should not be made more frequently than once a month. Patients treated once every two weeks whose haemoglobin concentration is above 10 g/dl (6.21 mmol/l) may receive this product administered once-monthly using the dose equal to twice the previous once-every-two-week dose.
For full details see prescribing information.
Treatment of anemia associated with chronic kidney disease (CKD).
Hypersensitivity to the active substance or any of the excipients. Patients with uncontrolled hypertension.
See prescribing information for full details.
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 microgram/l or with transferrin saturation below 20%. To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment. Failure to respond to therapy should prompt for a search for causative factors. Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, hemolysis, severe aluminum toxicity, underlying hematologic diseases, or bone marrow fibrosis may also compromise the erythropoietic response. A reticulocyte count should be considered as part of the evaluation. If all the conditions mentioned are excluded and the patient has a sudden drop of hemoglobin associated with reticulocytopenia and anti-erythropoietin antibodies, examination of the bone marrow for the diagnosis of Pure Red Cell Aplasia (PRCA) should be considered. In case PRCA is diagnosed, therapy must be discontinued and patients should not be switched to another ESA. Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with ESAs. These antibodies have been shown to cross-react with all ESAs, and patients suspected or confirmed to have antibodies to erythropoietin should not be switched to Mircera. Hemoglobin concentration: In patients with chronic kidney disease, maintenance hemoglobin concentration should not exceed the upper limit of the target hemoglobin concentration of 12 G/dl (7.45 mmol/l).
Blood pressure monitoring: Blood pressure may rise during treatment, and it should be adequately controlled in all patients before, at initiation of, and during treatment. If high blood pressure is difficult to control by medicdbal treatment or dietary measures, the dose must be reduced or withheld. Effect on tumor growth: Mircera is a growth factor that primarily stimulates red blood cell production. Erythropoietin receptors may be expressed on the surface of a variety of tumor cells. As with all growth factors, there is a concern that ESAs could stimulate the growth of any type of malignancy. Mircera is not approved for the treatment of anemia in patients with cancer. The safety and efficacy of therapy has not been established in patients with hemoglobinopathies, seizures, bleeding or a recent history of bleeding requiring tansfusions or with platelet levels greater than 500 x 109/l. Therefore, caution should be used in these patients.
Pregnancy and lactation: Caution should be exercised when prescribing to pregnant women. A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
The safety data base from clinical trials comprised 3,042 CKD patients, including 1,939 patients treated with this product and 1,103 with another ESA. Approximately 6% of patients treated with MIRCERA are expected to experience adverse reactions. The most frequent reported adverse reaction was hypertension (common).
For full details see prescribing information.
No interaction studies have been performed. There is no evidence that this product alters the metabolism of other medicinal products.
Pregnancy and Lactation
Pregnancy: There are no data from the use of this product in pregnant women. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development but indicate a class-related reversible reduction in foetal weight. Caution should be exercised when prescribing to pregnant women.
Breast-feeding: It is unknown whether this product is excreted in human breast milk. One animal study has shown excretion of methoxy polyethylene glycol-epoetin beta in maternal milk. A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with this product should be made taking into account the benefit of breast-feeding to the child and the benefit of this product therapy to the woman. Fertility Studies in animals have shown no evidence of impaired fertility. The potential risk for humans is unknown.
The therapeutic range of this product is wide. Individual responsiveness must be considered when treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis. In case of excessive haemoglobin levels, treatment with MIRCERA should be temporarily discontinued.If clinically indicated, phlebotomy may be performed.
Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 30°C for one single period of 1 month. Once removed from the refrigerator the medicinal product must be used within this period.
Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.