What is Mircera (methoxy polyethylene glycol-epoetin beta) used for?

From the Guidelines

Mircera is used for treating anemia associated with chronic kidney disease (CKD). This medication, which contains the active ingredient methoxy polyethylene glycol-epoetin beta, stimulates red blood cell production in the body to increase hemoglobin levels. Mircera is typically administered as an injection either intravenously or subcutaneously, with dosing usually starting at 0.6 micrograms per kilogram of body weight once every two weeks for patients not currently on erythropoiesis-stimulating agents (ESAs) 1. For patients already on ESAs, the starting dose depends on their previous treatment. Mircera has a longer half-life than other ESAs, allowing for less frequent dosing (typically once monthly after initial stabilization). Patients should have their hemoglobin levels monitored regularly during treatment, with dose adjustments made to maintain target levels, usually between 10-12 g/dL. The medication works by binding to the erythropoietin receptor on progenitor cells in the bone marrow, stimulating their differentiation into red blood cells to counteract the anemia commonly experienced in kidney disease.

Some key points to consider when using Mircera include:

• Starting and modifying doses of ESA should follow FDA guidelines 1
• Dose escalation should follow FDA-approved labeling, and no convincing evidence exists to suggest that differences in dose-escalation schedules are associated with different effectiveness 1
• Continuing epoetin or darbepoetin treatment beyond 6 to 8 weeks in the absence of response does not seem to be beneficial, and ESA therapy should be discontinued 1
• Hb can be increased to the lowest concentration needed to avoid transfusions, which may vary by patient and condition 1
• Baseline and periodic monitoring of iron, total iron-binding capacity, transferrin saturation, or ferritin levels and instituting iron repletion when indicated may help to reduce the need for ESAs, maximize symptomatic improvement for patients, and determine the reason for failure to respond adequately to ESA therapy 1

From the FDA Drug Label

Mircera is a prescription medicine used to treat anemia in certain people with chronic kidney disease (CKD). People with anemia have a lower-than-normal number of RBCs. Mircera works like the human protein called erythropoietin to help your body make more RBCs. Mircera is used to reduce or avoid the need for RBC transfusions Mircera may be used to treat anemia if it is caused by CKD in: • adults who may or may not be on dialysis • children 3 months to 17 years of age who may or may not be on dialysis who are switching from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level is stable

Mircera is used for treating anemia caused by chronic kidney disease (CKD) in:

• Adults who may or may not be on dialysis
• Children 3 months to 17 years of age who may or may not be on dialysis and are switching from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level is stable 2

From the Research

Mircera Usage

• Mircera, also known as methoxy polyethylene glycol-epoetin beta, is used to treat anemia associated with chronic kidney disease (CKD) 3, 4, 5, 6, 7.
• It is a continuous erythropoietin receptor activator with a long half-life, allowing for less frequent administration compared to other erythropoiesis-stimulating agents (ESAs) 3, 5.
• Mircera can be administered intravenously or subcutaneously, and its dosage can be adjusted based on the patient's response to treatment 3, 4, 7.

Patient Populations

• Mircera is effective in treating anemia in adult patients with CKD, both on and not on dialysis 3, 5, 7.
• It is also used in pediatric patients with CKD, with studies showing its safety and efficacy in this population 4.
• Mircera can be used in patients who have not previously received an ESA, as well as those who have been switched from another ESA 3, 5.

Administration and Dosage

• Mircera can be administered once every 2 weeks or once a month, depending on the patient's response to treatment 3, 4, 7.
• The dosage of Mircera can be adjusted based on the patient's hemoglobin levels, with the goal of maintaining stable hemoglobin levels within a target range 3, 4, 7.
• Studies have shown that Mircera is generally well-tolerated, with most adverse events being mild to moderate in severity 3, 4, 5, 7.