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Composition:


active ingredient: methoxy polyethylene glycol-epoetin beta;


1 pre-filled syringe with 0.3 ml of solution for injection contains 50 mcg or 75 mcg of methoxy polyethylene glycol-epoetin beta;


excipients: L-methionine; sodium sulfate anhydrous; sodium dihydrogen phosphate, monohydrate; mannitol (E 421); poloxamer 188; dilute hydrochloric acid or sodium hydroxide solution (q.s. up to PH 6.2); water for injection.


Dosage form. Solution for injection.


Basic physical and chemical properties: clear liquid from colorless to slightly yellowish in color.


Pharmacotherapeutic group.


Other anti-anemic agents. ATX code B03X A03.


Pharmacological properties.


Pharmacodynamics.


Myrcera stimulates erythropoiesis by interacting with erythropoietin receptors on bone marrow progenitor cells. Methoxy polyethylene glycol-epoetin beta, the active substance of Mircera, is a long-term activator of erythropoietin receptors, which, unlike erythropoietin, shows different activity at the receptor level, characterized by slower binding and faster separation from the receptor, reduced specific activity in vitro and increased activity in vivo, as well as a longer Half-Life. The average molecular weight of methoxy polyethylene glycol-epoetin beta is approximately 60 KDA, including approximately 30 KDA of the molecular weight of the protein and carbohydrate portion.


The dose of the drug indicates the amount of protein in the molecule methoxy polyethylene glycol-epoetin beta without taking into account glycosylation. The protein is synthesized using recombinant DNA technology in Chinese hamster ovarian cells and covalently conjugated with linear polyethylene glycol (PEG).


The natural hormone Erythropoietin, the main growth factor for erythroid development, is produced by the kidneys and released into the vascular bed in response to hypoxia. In response to hypoxia, erythropoietin interacts with erythropoiesis progenitor cells, which leads to an increase in red blood cell production.


Clinical efficacy


The results of studies of anemia correction in patients treated with Mircera with a frequency of administration once every 2 weeks or once every 4 weeks show that the frequency of hemoglobin response in the Mircera group at the end of the correction period was high and comparable with the comparison groups. The average response period was 43 days in the Myrcera group and 29 days in the comparison group, with an increase in hemoglobin during the first 6 weeks of 0.2 g/dL/week and 0.3 g/dL/week, respectively.


So far, 4 randomized controlled trials have been conducted in patients who were on dialysis and received darbepoietin alpha or epoetin at the time of inclusion in the study. At the time of inclusion in the study, patients were randomized to receive erythropoietin therapy, which patients received earlier, or to switch to treatment with Mircera in order to achieve stable hemoglobin levels. During the evaluation period (29-36 weeks), the mean and median hemoglobin levels in patients treated with Myrcera were virtually identical to the initial hemoglobin level.


Myrcera is not approved for the treatment of patients with chemotherapy-induced anemia.


Pharmacokinetics.


The pharmacokinetics of methoxy polyethylene glycol-epoetin beta were studied in healthy volunteers and in patients with chronic kidney disease and anemia, including patients who are / are not on dialysis.


After subcutaneous administration to patients with chronic kidney disease who did not receive dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (average) after administration. The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 54 %. The terminal Half-Life was 142 hours in patients with chronic kidney disease who were not on dialysis.


After subcutaneous administration to patients with chronic kidney disease undergoing dialysis, maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (mean) after administration. The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62 %. The terminal Half-Life was 139 hours in patients with chronic kidney disease undergoing dialysis.


After intravenous administration to patients with chronic kidney disease undergoing dialysis, the total systemic clearance was 0.494 ML/H/kg. After intravenous administration, the Half-Life of methoxy polyethylene glycol-epoetin beta was 134 hours.


Comparison of serum methoxy polyethylene glycol-epoetin beta concentrations determined before and after hemodialysis in 41 patients with chronic kidney disease showed that hemodialysis does not affect the pharmacokinetics of Myrcera. Analysis of data on 126 patients with chronic renal failure showed no difference in pharmacokinetic parameters in patients receiving and not receiving dialysis.


In a single-dose study after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epoetin beta are comparable in patients with severe hepatic insufficiency and in healthy volunteers (see the section "dosage and administration").


Clinical characteristics.


Indications.


Treatment of symptomatic anemia associated with chronic kidney disease.


Contraindications.


Hypersensitivity to methoxy polyethylene glycol-epoetin beta or to any excipient of the drug (see the section "excipients"). Uncontrolled arterial hypertension.


Interactions with other drugs and other types of interactions.


Studies of the interaction of the drug Myrcera have not been conducted. There is no evidence that Myrcera affects the metabolism of other drugs.

Application features.


The safety and efficacy of Myrcera therapy for other indications for use, including anemia in patients with malignant tumors, have not been established.


Caution should be exercised when increasing the dose of Mircera in patients with chronic renal failure, as high cumulative doses of Epoetin may be associated with an increased risk of death, serious cardiovascular and cerebrovascular complications. If the patient has a weak hemoglobin response to epoetin treatment, alternative explanations should be considered (see the section "dosage and administration").


Supplemental iron therapy is recommended for all patients with serum ferritin levels of less than 100 mcg/L or transferrin iron saturation of less than 20 %. To ensure effective erythropoiesis, iron levels should be determined in all patients before and during treatment.


If there is no response to treatment with Myrcera, it is necessary to initiate a search for causal factors. Deficiency of iron, folic acid and vitamin B12 reduces the effectiveness of therapy with agents that stimulate erythropoiesis, so the deficiency of these substances should be corrected. Intercurrent infections, inflammatory processes, injuries, latent blood loss, hemolysis, severe aluminum toxicity, existing blood diseases, and bone marrow fibrosis can also lead to a decrease in the effectiveness of therapy with drugs that stimulate erythropoiesis. When examining patients, the number of reticulocytes should also be determined. In case of exclusion of these conditions and with a sudden decrease in hemoglobin levels associated with reticulocytopenia and detection of antibodies to erythropoietin, it is necessary to conduct a bone marrow study to exclude the diagnosis of true erythrocyte aplasia. If the diagnosis of true erythrocytic aplasia is confirmed, treatment with Myrcera should be discontinued, and patients should not be transferred to treatment with other agents that stimulate erythropoiesis.


At the request of the doctor, Roche will offer testing or retesting of serum samples in a reference laboratory. This service is free of charge in case of suspicion or confirmation of true erythrocyte aplasia mediated by antibodies to erythropoietin, or unexplained loss of effect during treatment with Mircera (for example, clinically observed as severe anemia with a low reticulocyte count).

Pregnancy


There are no data on the use of Myrcera in pregnant women.


In animal studies, there was no direct harmful effect of Myrcera on pregnancy, embryo development, fetal development, childbirth and postnatal development, but there was a reversible decrease in fetal weight associated with the use of a class of agents that stimulate erythropoiesis. Use Myrcera in pregnant women with caution.


Breast-feeding period


It is not known whether Myrcera is excreted in human breast milk. In one animal study, methoxy polyethylene glycol-epoetin beta was shown to be excreted in mother's milk. The decision to continue or discontinue breast-feeding or to continue or discontinue therapy with Mircera should be made taking into account the benefits of breast-feeding for the child and the benefits of treatment with Mircera for the woman.


Fertility


In animal studies, no signs of impaired fertility were found. The potential risk to humans is unknown.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


The drug does not affect or has little effect on the ability to drive vehicles and work with machines and mechanisms.


Dosage and administration.


Treatment with Mircera should be carried out under the supervision of a doctor who has experience in the treatment of patients with renal insufficiency.


Mircera can be administered subcutaneously or intravenously. Myrcera is injected subcutaneously into the abdomen, shoulder, or thigh. These areas are equally suitable for subcutaneous administration.


Treatment of symptomatic anemia in adults with chronic kidney disease


Symptoms of anemia and its consequences may vary depending on age, gender, and overall severity of the disease, so a doctor should assess the individual course of the disease and the patient's condition.


The drug can be used subcutaneously or intravenously to increase hemoglobin to a level not exceeding 12 g/dL (7.45 mmol/L). Subcutaneous administration should be preferred in patients who are not on hemodialysis, in order to avoid puncture of peripheral veins.


Due to individual variability, an individual patient may rarely have a hemoglobin level higher or lower than the desired hemoglobin level. The variability of hemoglobin levels can be affected by dose adjustment, taking into account the target range of hemoglobin levels from 10 g/dL (6.21 mmol/L) to 12 g/dL (7.45 mmol/L). A persistent increase in hemoglobin to levels above 12 g/dL (7.45 mmol/l) should be avoided; recommendations for appropriate dose adjustment if hemoglobin levels rise above 12 g/dL (7.45 mmol/L) are given below.


Avoid increasing hemoglobin levels above 2 g/dL (1.24 mmol/L) over a 4-week period. If this situation occurs, the dose of Myrcera should be adjusted.


Patients should be carefully monitored to ensure that they receive the lowest approved effective dose of Myrcera in order to adequately control the symptoms of anemia while maintaining a hemoglobin concentration below or at 12 g/dL (7.45 mmol/L).


Caution should be exercised when increasing the dose of Myrcera for patients with chronic renal failure. If the patient has a weak hemoglobin response to the use of Myrcera, alternative explanations should be considered (see the section "application specifics").


Hemoglobin levels should be monitored every 2 weeks until they stabilize, followed by periodic monitoring.

Discontinuation of treatment


Treatment with Myrcera is usually long-term. If necessary, treatment can be discontinued at any time.


Missed dose


If one dose of Myrcera is missed, it should be administered as soon as possible. Administration of Myrcera should be resumed with the frequency that was used earlier.


Special dosage recommendations


Use for children


It is not recommended to use Mircera in children under 18 years of age due to the lack of data on the effectiveness and safety of its use in this category of patients.


Elderly patients


In clinical trials, 24% of patients treated with Mircera were aged,


between 65 and 74 years of age, 20% of patients were 75 years of age or older. Elderly patients over 65 years of age do not need to adjust the dose.

Tags: Mircera® [Methoxypolyethylene glycol-epoetin beta]