Mircera 100 µg/0.3 ml (IV/SC Injection)

Title

• Mircera Polyethylene Glycol Epoetin Beta

Categories

• Medicine
• Erythropoiesis Stimulating Agent (ESA)
• Anemia Treatment
• Pharmaceutical
• Healthcare
• Nephrology

Description

• Treatment of anemia associated with chronic kidney disease (CKD)
• Administered subcutaneously (s.c.) or intravenously (i.v.)
• Stimulates erythropoiesis by interacting with the erythropoietin receptor on progenitor cells in the bone marrow
• Once monthly dosing regimen for patients
• No interaction studies have been performed
• Contraindicated in patients with uncontrolled hypertension or known hypersensitivity to the active substance or any of the excipients
• Adverse reactions include hypertension, vascular access thrombosis, headache, hypersensitivity, hypertensive encephalopathy, rash (maculo-papular, serious)
• Caution advised for use in pregnant women, and breastfeeding mothers
• Supplementary iron therapy recommended for all patients with serum ferritin values below 100 µg/l or transferrin saturation below 20%
• Not recommended for use in patients aged less than 18 years
• Wide therapeutic range, individual response to therapy must be considered
• Storage in the refrigerator at 2°C to 8°C, do not freeze, protect from light

Indications

• Treatment of anemia associated with chronic kidney disease (CKD) including patients on dialysis and patients not on dialysis

Pharmacology

• Chemically synthesized continuous erythropoietin receptor activator
• Integration of an amide bond between N-terminal amino group and methoxy polyethylene glycol butanoic acid
• Molecular weight approximately 60,000 daltons with PEG-moiety approximately 30,000 daltons
• Shows different activity at the receptor level characterized by slower association and faster dissociation, reduced specific activity in vitro with increased activity in vivo, and increased half-life
• Stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow

Dosage & Administration

• Administered subcutaneously (s.c.) or intravenously (i.v.)
• Recommended starting dose of 1.2 microgram/kg body weight administered once every month as a single subcutaneous injection for patients not on dialysis
• Recommended starting dose of 0.6 microgram/kg body weight may be administered once every two weeks as a single IV or SC injection for patients not on dialysis
• Recommended starting dose of 0.6 microgram/kg body weight may be administered once every two weeks as a single IV or SC injection for patients on dialysis
• Dose adjustments based on rate of rise in hemoglobin level and individual target hemoglobin level
• Patients currently treated with an ESA can be converted to Mircera Polyethylene Glycol Epoetin Beta

Interaction

• No interaction studies have been performed
• Clinical results do not indicate any interaction with other medicinal products

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

• Caution advised for use in pregnant women
• No adequate data on use in pregnant women
• Animal studies do not indicate direct or indirect harmful effects
• Unknown excretion in human breast milk
• A decision on breastfeeding and therapy should be made considering the benefit to the child and the woman

Precautions & Warnings

• Supplementary iron therapy recommended for patients with low serum ferritin or transferrin saturation
• Lack of effect due to iron deficiency and inflammatory disorders
• Concern for Pure Red Cell Aplasia (PRCA)
• Blood pressure monitoring during treatment
• High blood pressure should be controlled before and during treatment

Use in Special Populations

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

Overdose Effects

• Wide therapeutic range, individual response to therapy must be considered
• Manifestations of exaggerated pharmacodynamic effect
• Temporary withholding in case of excessive hemoglobin levels
• Phlebotomy may be performed if clinically indicated

Therapeutic Class

• Drugs for Haemolytic Hypoplastic & Renal Anemia

Storage Conditions

• Refrigerate at 2°C to 8°C
• Do not freeze
• Protect from light
• Storage at room temperature (not above 30°C) for one single period of 1 month after removal from refrigeration

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