Mircera Injection

Mircera Injection is used for: Anaemia associated with chronic kidney disease

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

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

Hypersensitivity. Uncontrolled HTN. Pure red cell aplasia that begins after treatment

Discontinue if pure red cell aplasia. Adequate control of BP. Hemoglobinopathies, seizures, platelet level >500 x 109/L. Patients <18 yr. Using ESA to target a hemoglobin level of > 11 g/dL increase the rate of serious adverse cardiovascular Control hypertension prior to initiating of and during treatment with it Monitoring of patients for the change in seizure frequency or premonitory symptoms. If severe anemia and low reticulocyte count develop during the treatment, withhold it and evaluate patients for neutralizing antibodies to erythropoietin Lactation: not known if excreted in breast milk, use caution

Pregnancy Available data from published case reports and postmarketing experience with use in pregnancy are insufficient to identify a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes Chronic kidney disease is associated with maternal and embryo-fetal risks Animal data In animal reproduction studies, administration of methoxy polyethylene glycolepoetin beta to rats and rabbits during pregnancy and lactation adversely affected offspring at doses 17-fold and greater than the recommended human dose Clinical consideration Pregnancy in women with chronic kidney disease has been associated with adverse outcomes (eg, hypertension, pre-eclampsia, miscarriage, premature birth, low-birth-weight, polyhydramnios, and intrauterine growth restriction) Lactation There are no data on the presence of methoxy polyethylene glycol-epoetin beta in human milk, the effects on the breastfed child, or the effects on milk production However, endogenous erythropoietin is present in human milk Animal data In rats, methoxy polyethylene glycol-epoetin beta was present in maternal milk

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

Side effects of Methoxy Polyethyelene Glycol-Epoetin Beta (Pegylated Erythropoietin) : >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

Methoxy Polyethyelene Glycol-Epoetin Beta is an erythropoietin receptor activator w/ greater activity as well as increased half-life, in contrast to erythropoietin. Erythropoietin is a growth factor for erythroid development. It is produced in the kidney and released into the bloodstream in response to hypoxia, interacting with erythroid progenitor cells to increase red blood cell production. Production of endogenous erythropoietin is impaired in patients with chronic kidney disease (CKD), and erythropoietin deficiency is the primary cause of their anaemia. Administration of methoxy polyethylene glycol-epoetin beta acts like endogenous erythropoetin and stimulates erythropoetin receptor of the erythroid progenitor cells in the bone marrow.

Mircera 360mcg/0.6ml Injection manufactured by F. Hoffmann-La Roche Ltd.. Its generic name is Methoxy Polyethyelene Glycol-Epoetin Beta (Pegylated Erythropoietin). Mircera is availble in United Arab Emirates. Farmaco UAE drug index information on Mircera Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.