Mircera 75 Injection – (75mcg/0.3ml)

Radiant Pharmaceuticals Ltd.

Generic: Methoxy Polyethyelene Glycol-Epoetin Beta

Weight

0.015 kg

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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 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…

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.

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