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Mircera Generic Name & Formulations
Legal Class
Rx
General Description
Methoxy polyethylene glycol-epoetin beta 30mcg/0.3mL, 50mcg/0.3mL, 75mcg/0.3mL, 100mcg/0.3mL, 120mcg/0.3mL, 150mcg/0.3mL, 200mcg/0.3mL, 250mcg/0.3mL; 360mcg/0.6mL; soln for SC or IV inj; preservative-free.
Pharmacological Class
Erythropoiesis stimulating protein.
How Supplied
Single-dose prefilled syringe—1 (w. supplies)
Manufacturer
Generic Availability
NO
Mircera Indications
Indications
Treatment of anemia associated with chronic kidney disease (CKD) in adults on or not on dialysis and in pediatric patients on hemodialysis who are converting from another erythropoietin-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA.
Limitations of Use
Not recommended to treat anemia due to cancer chemotherapy. Not a substitute for red blood cell (RBC) transfusions in patients who require immediate anemia correction. Not shown to improve symptoms, physical functioning, or health-related quality of life.
Mircera Dosage and Administration
Adult
See full labeling. Individualize. Do not increase dose sooner than once every 4 weeks. Avoid frequent dose adjustments. Give as SC (abdomen, arm, or thigh) or IV inj. >17yrs: Dialysis (hemoglobin <10g/dL): initially 0.6mcg/kg as a single injection once every 2 weeks; interrupt or reduce dose if hemoglobin approaches or exceeds 11g/dL. Once stabilized, double the dose and give once monthly. Non-dialysis (hemoglobin <10g/dL, RBC transfusion likely + reduced risk of alloimmunization and/or transfusion-related goals): initially 0.6mcg/kg as a single injection once every 2 weeks; interrupt or reduce dose if hemoglobin >10g/dL. Once stabilized, double the dose and give once monthly. Reduce dose by ≥25% if hemoglobin rises >1g/dL in any 2-week period. Increase dose by 25% if inadequate response (<1g/dL increase) after 4 weeks; discontinue if response not improved after a 12-week escalation period. Conversion from epoetin alfa or darbepoetin alfa: see full labeling.
Children
See full labeling. Individualize. Do not increase dose sooner than once every 4 weeks. Avoid frequent dose adjustments. Give as IV inj once every 4 weeks. <5yrs: not established. 5–17yrs: Conversion from epoetin alfa: 4 x previous weekly epoetin alfa dose (Units)/125. Conversion from darbepoetin alfa: 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. Reduce dose by ≥25% if hemoglobin rises >1g/dL in any 2-week period. Increase dose by 25% if inadequate response (<1g/dL increase) after 4 weeks; discontinue if response not improved after a 12-week escalation period.
Mircera Contraindications
Contraindications
Uncontrolled hypertension. Pure red cell aplasia (PRCA) occurring after Mircera treatment or other erythropoetin protein drugs.
Mircera Boxed Warnings
Boxed Warning
ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.
Mircera Warnings/Precautions
Warnings/Precautions
Increased risk of mortality, myocardial infarction, stroke, thromboembolism with higher hemoglobin targets (>11g/dL). Coexisting cardiovascular disease and stroke. Increased risk of mortality and/or risk of tumor progression or recurrence in cancer patients. Control hypertension prior to and during treatment; reduce or withhold dose if BP becomes uncontrolled. Evaluate iron status prior to and during treatment; give supplemental iron if serum ferritin <100mcg/L or transferrin saturation <20%. Correct or exclude other causes of anemia prior to initiation. Monitor hemoglobin weekly until stable, then at least monthly. Use lowest effective dose to reduce the need for RBC transfusions. Monitor for premonitory neurologic symptoms during first several months. Withhold dose and evaluate for neutralizing antibodies if severe anemia and low reticulocyte count develop; permanently discontinue if PRCA occurs. Permanently discontinue if serious allergic/anaphylactic reaction or severe cutaneous reaction (eg, SJS/TEN) occurs. Pregnancy. Nursing mothers.
Mircera Pharmacokinetics
See Literature
Mircera Interactions
Interactions
May require increased anticoagulation (heparin) during hemodialysis.
Mircera Adverse Reactions
Adverse Reactions
Hypertension, diarrhea, nasopharyngitis; seizures, thromboembolism, PRCA, serious allergic reactions, severe cutaneous reactions.
Mircera Clinical Trials
See Literature
Mircera Note
Not Applicable
Mircera Patient Counseling
See Literature
