Mircera 50

Anaemia associated with chronic kidney disease

IV route is recommended for patients receiving hemodialysis because IV route may be less immunogenic SC: inject in abdomen, arm or thigh

Patients with chronic renal failure on dialysis Initiate treatment when hemoglobin level < 10 g/dL If hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt dose Dose if not currently on ESA therapy: 0.6 mcg/kg IV/SC q2week initially Once hemoglobin has been stabilized, dose may be administered once monthly using a dose that is twice that of every-two-week dose and subsequently titrated as necessary Patients with chronic renal failure not on dialysis Consider initiating treatment only when hemoglobin level is < 10 g/dL and the following considerations apply. Rate of hemoglobin decline indicates likelihood of requiring a RBC transfusion and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal If hemoglobin level >10 g/dL, reduce or interrupt dose, and use lowest dose sufficient to reduce need for RBC transfusions Dose if not currently on ESA therapy: 0.6 mcg/kg IV/SC q2week initially Once hemoglobin has been stabilized, Mircera may be administered once monthly using a dose that is twice that of the every-two-week dose and subsequently titrated as necessary Switching Patients Currently on Other ESA Receiving epoetin <8000 units/week or darbepoetin <40 mcg/week: 120 mcg/qmonth or 60 mcg/q2week IV/SC Receiving epoetin 8000-16000 units/week or darbepoetin 40-80 mcg/week: 200 mcg/qmonth or 100 mcg/q2week IV/SC Receiving epoetin >16000 units/week or darbepoetin >80 mcg/week: 360 mcg/qmonth or 180 mcg/q2week IV/SC Anemia Associated with Chronic Renal Failure Do not increase dose more frequently than q4weeks; decreases in dose can occur more frequently; avoid frequent dose adjustments If hemoglobin rises rapidly (e.g., > 1 g/dL in any 2-week period), reduce dose by 25% or more as needed to reduce rapid responses For patients who do not respond adequately, if hemoglobin has not increased by >1 g/dL after 4 weeks of therapy, increase dose by 25% For patients who do not respond adequately over a 12-week escalation period, increasing dose further is unlikely to improve response and may increase risks; use lowest dose that will maintain a hemoglobin level sufficient to reduce need for RBC transfusions; evaluate other causes of anemia; discontinue if responsiveness does not improve Dose Adjustment Dose adjustments should NOT be >qMonth

Safety & efficacy not established

Hypersensitivity. Uncontrolled HTN.

Methoxy Polyethyelene Glycol-Epoetin Beta is an erythropoietin receptor activator w/ greater activity as well as increased half-life, in contrast to erythropoietin.

Discontinue if pure red cell aplasia. Adequate control of BP. Hemoglobinopathies, seizures, platelet level >500 x 109/L. Patients <18 yr. Lactation: not known if excreted in breast milk, use caution

>10% Hypertension (13%),Diarrhea (11%),Nasopharyngitis (11%) 1-10% Headache (9%),Upper respiratory tract infection (9%),Cough (6%),Hypotension (5%),Urinary tract infection (5%),Procedural arteriovenous fistula thrombosis (5%) Frequency Not Defined Coronary artery disease,Anemia,Septic shock,Serious cardiovascular and thromboembolic events,Seizures,Immunogenicity related PRCA,Increased mortality and/or tumor progression in cancer patients,Increased mortality,Concomitant termination of other CRF therapy,Stevens-Johnson syndrome,Toxic epidermal necrolysis

No interaction studies have been performed. There is no evidence that Mircera alters the metabolism of other medicinal products.