Mircera 50 µg/0.3 ml (IV/SC Injection)

Indications

• Treatment of anemia associated with chronic kidney disease (CKD)
• Patients on dialysis
• Patients not on dialysis

Pharmacology

• Chemically synthesized continuous erythropoietin receptor activator
• Molecular weight of approximately 60,000 daltons
• Interaction with the erythropoietin receptor on progenitor cells in the bone marrow
• Stimulates erythropoiesis
• Produced in the kidney and released into the bloodstream in response to hypoxia

Dosage & Administration

• Administered subcutaneously or intravenously
• Monitoring of hemoglobin levels
• Monthly dosing regimen
• Injection sites: abdomen, arm, thigh
• Recommended starting dose for patients not on dialysis: 1.2 microgram/kg body weight once every month

Interaction

• No interaction studies performed
• No indications of effect of concomitant medications on pharmacokinetics and pharmacodynamics

Contraindications

• Uncontrolled hypertension
• Known hypersensitivity to the active substance or any of the excipients

Side Effects

• Hypertension
• Vascular access thrombosis
• Headache
• Hypersensitivity
• Hypertensive encephalopathy
• Rash (maculo-papular, serious)

Pregnancy & Lactation

• Limited data on use in pregnant women
• Caution advised during pregnancy
• Excretion in human breast milk

Precautions & Warnings

• Supplementary iron therapy recommended for patients with low serum ferritin values
• Lack of effect reasons: iron deficiency, inflammatory disorders, chronic blood loss, bone marrow fibrosis, severe aluminum overload, folic acid or vitamin B12 deficiencies, and hemolysis
• Examination for diagnosis of Pure Red Cell Aplasia (PRCA) recommended if sudden drop of hemoglobin associated with reticulocytopenia and anti-erythropoietin antibodies
• Blood pressure monitoring
• PRCA reported in association with ESAs including MIRCERA

Use in Special Populations

• Not recommended for patients aged less than 18 years
• No dose adjustment in patients aged 65 years or older
• No adjustment in patients with any degree of hepatic impairment

Overdose Effects

• Wide therapeutic range
• Manifestations of excessive erythropoiesis
• Temporary withholding of Mircera Polyethylene Glycol Epoetin Beta
• Clinical indication for phlebotomy

Therapeutic Class

• Drugs for Haemolytic Hypoplastic & Renal Anemia

Storage Conditions

• Refrigeration at 2°C to 8°C
• Protection from light
• Storage at room temperature (not above 30°C) for one month once removed from refrigerator

Related Brands

• Mircera 75 µg/0.3 ml (IV/SC Injection) - roche-bangladesh-ltd
• Mircera 100 µg/0.3 ml (IV/SC Injection) - roche-bangladesh-ltd