MIRCERA
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA · by MARTIN DOW
Composition
Inj 30 mcg/50 mcg/75 mcg/100 mcg/120 mcg/150 mcg/200 mcg/250 mcg/360 mcg: Pre- filled syringe: Methoxy polyethylene glycol-epoetin beta 30 mcg (0.3 ml), 50 mcg (0.3 ml), 75 mcg (0.3 ml), 100mcg(0.3 ml), 120 mcg(0.3 ml), 150 mcg(0.3 ml), 200 mcg(0.3 ml), 250 mcg(0.3 ml), 360 mcg(0.3 ml).
Indications & Dosage
Symptomatic anaemia associated with chronic renal failure: BY IV OR SC INJ: Adult: Erythropoiesis stimulating agent (ESA) naive patients: 0.6 mcg/kg once every two wk by IV or SC inj. Adjust dose according to haemoglobin levels at minimum 4 wk intervals. Erythropoiesis stimulating agent (ESA) treated patients:120-360 mcg/kg once monthly by IV or SC inj according to previous ESA dose. Adjust dose according to haemoglobinlevels at minimum 4 wk intervals. See literature. Children: Not recommended.
Administration
Treatment has to be initiated under the supervision of a healthcare professional. Treatment of anemic patients with chronic kidney disease: The solution can be administered SC or IV, according to clinical preference. Injected SC in the abdomen, arm or thigh. Monitor HB every two Weeks until stabilized, and periodically thereafter.
Contraindications
Uncontrolled hypertension. Pure red cell aplasia following erythropoietin therapy. Patients unable to receive thromboprophylaxis. Severe cardiovascular disease including recent MI or cerebral vascular accident in patients scheduled for major orthopaedic surgery.
Precautions
Hypertension; Carefully monitor BP and discontinue treatment if BP uncontrolled. Ischaemic vascular disease, epilepsy, chronic hepatic disease, porphyria. Thrombocytosis; monitor platelet count for first 8 weeks. Correct other causes of anaemia before treatment; iron supplements may be necessary. Risk of thromboembolic events; monitor Hb levels. Chronic Renal Failure Patients: Regularly monitor for loss of efficacy in patients administered r-HuEPOs via the SC route. Risk of shunt thrombosis in haemodialysis patients; thromboprophylaxis is recommended,Hyperkalaemia;Monitor serum electrolytes.
Interactions
Drugs highly bound to red cells e.g. Cyclosporin.
Pregnancy
Risk cannot be ruled out.
Lactation
Caution advised or effect undetermined.
Side Effects
Dose dependent increase in BR aggravation of hypertension, deep vein thrombosis, pulmonary embolism.seizures, GI upset, headache, flu like symptoms, rash. arthralgia, red cell aplasia.