Mircera 50 - Injection Methoxy Polyethyelene Glycol-Epoetin Beta - 50mcg/0.3ml 1 Injection(s) / Injection Roche Bangladesh Pharmaceutical Indication: Anaemia associated with chronic kidney disease Administration: IV route is recommended for patients receiving hemodialysis because IV route may be less immunogenic SC: inject in abdomen, arm or thigh Adult Dose: Patients with chronic renal failure on dialysis Initiate treatment when 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 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... Child Dose: Safety & efficacy not established Contraindication: Hypersensitivity. Uncontrolled HTN. Mode of Action: Methoxy Polyethyelene Glycol-Epoetin Beta is an erythropoietin receptor activator w/ greater activity as well as increased half-life, in contrast to erythropoietin. Precaution: 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 Side Effect: >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 Interaction: No interaction studies have been performed. There is no evidence that Mircera alters the metabolism of other medicinal products.