Mircera 75 µg/0.3 ml (IV/SC Injection)

Indications

• Treatment of anemia associated with chronic kidney disease
• Treatment for patients on dialysis
• Treatment for patients not on dialysis

Pharmacology

• Continuous erythropoietin receptor activator
• Chemically synthesized
• Integration of amide bond
• Molecular weight approximately 60,000 daltons
• Increased half-life
• Stimulates erythropoiesis by interaction with the erythropoietin receptor

Dosage & Administration

• Administered subcutaneously or intravenously
• Dosing regimen varies based on patient's condition
• Hemoglobin monitoring every two weeks until stabilized

Interaction

• No interaction studies performed
• No indication of concomitant medications affecting pharmacokinetics and pharmacodynamics

Contraindications

• Uncontrolled hypertension
• Known hypersensitivity to active substance or excipients

Side Effects

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

Pregnancy & Lactation

• Caution in prescribing to pregnant women
• No direct or indirect harmful effects indicated in animal studies
• Excretion in human breast milk indicated in animal study

Precautions & Warnings

• Supplementary iron therapy recommended for patients with low serum ferritin
• Conditions compromising effectiveness of therapy
• Consideration of Pure Red Cell Aplasia (PRCA) if incomplete response
• Blood pressure monitoring during treatment
• Risk of blood pressure rise

Use in Special Populations

• Not recommended for use in patients aged less than 18 years
• No adjustment needed for patients aged 65 years or older
• No adjustments required for patients with hepatic impairment

Overdose Effects

• Therapeutic range is wide
• Manifestations of excessive erythropoiesis in case of overdose
• Temporary withholding of product if overdosed
• Possibility of phlebotomy if clinically indicated

Therapeutic Class

• Drugs for Haemolytic Hypoplastic & Renal Anemia

Storage Conditions

• Refrigeration at 2°C to 8°C
• Protection from light
• Not to be frozen
• Room temperature storage (not above 30°C) for one month after removal from refrigeration

Related Brands

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