Generic
Methoxy Polyethylene Glycol-Epoetin Beta
3 brands available in the market
At a glance
Methoxy Polyethylene Glycol-Epoetin Beta is a long-acting erythropoietin receptor activator used to treat anemia associated with chronic kidney disease.
Description
Methoxy polyethylene glycol-epoetin beta (Mircera) is a chemically synthesized continuous erythropoietin receptor activator. It stimulates erythropoiesis by interacting with the erythropoietin receptor on progenitor cells in the bone marrow. Thanks to its long half-life, it allows for once-monthly or once-every-two-weeks dosing, making it convenient for patients and improving treatment adherence. The drug increases hemoglobin levels and reduces the need for blood transfusions.
Indications
- Anemia associated with chronic kidney disease (CKD)
- Anemia in patients on dialysis
- Anemia in patients not on dialysis
Therapeutic class
Drugs for Haemolytic, Hypoplastic & Renal Anemia
Pharmacological class
Erythropoiesis-Stimulating Agent (ESA)
Pharmacology
Methoxy polyethylene glycol-epoetin beta is a continuous erythropoietin receptor activator. It binds to the erythropoietin receptor on bone marrow cells to increase red blood cell production. It demonstrates greater activity and increased half-life compared to natural erythropoietin.
Mechanism of action
Stimulates red blood cell production in the bone marrow to treat anemia.
Dosage
Adult Dose:
- Patients on Dialysis (Starting): 0.6 mcg/kg, once every two weeks (IV/SC)
- Patients NOT on Dialysis (Starting): 1.2 mcg/kg, once a month (SC); OR 0.6 mcg/kg, once every two weeks (IV/SC)
- Conversion from Other ESAs: Dose is based on the patient's previous weekly dose of epoetin or darbepoetin alfa
- Dose Adjustment: Can be increased or decreased by 25-50% monthly
Pediatric Dose: Safety and efficacy not established in patients under 18 years.
Administration
- Intravenous (IV): Inject slowly during or after dialysis
- Subcutaneous (SC): Inject into the abdomen, arm, or thigh
- Administered by trained healthcare professionals
- Monitor hemoglobin every two weeks until stable
Missed dose
If you miss a dose, take it as soon as you remember. If it's almost time for the next dose, skip the missed dose. Do not double the dose.
Side effects
Common (>10%):
- Hypertension (13%)
- Diarrhea (11%)
- Nasopharyngitis (11%)
Uncommon (1-10%):
- Headache (9%)
- Upper respiratory tract infection (9%)
- Cough (6%)
- Hypotension (5%)
- Urinary tract infection (5%)
Rare:
- Seizures
- Pure Red Cell Aplasia (PRCA)
- Allergic reactions
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
Precautions & warnings
- Monitor blood pressure closely before, during, and after treatment - ensure adequate control
- Assess iron status and provide iron supplementation if ferritin <100 µg/L or transferrin saturation <20%
- If hemoglobin rises >1 g/dL in any 2-week period, reduce the dose
- If Pure Red Cell Aplasia (PRCA) is diagnosed, discontinue MIRCERA and do not switch to another ESA
- Caution in hemoglobinopathies, seizures, platelet level >500 x 109/L
Contraindications
- Uncontrolled hypertension
- Known hypersensitivity to Methoxy Polyethylene Glycol-Epoetin Beta or any of its components
Drug interactions
No significant drug interactions have been identified. A population analysis showed no effect of concomitant medications on its pharmacokinetics or pharmacodynamics.
Food interactions
Can be taken with or without food.
Use in pregnancy
Use in Pregnancy: There is limited data on use in pregnant women. Animal studies do not indicate harmful effects on pregnancy, embryonal/fetal development, or postnatal development. Use with caution during pregnancy.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: It is unknown if methoxy polyethylene glycol-epoetin beta is excreted in breast milk. Animal studies have shown excretion in maternal milk. Caution is advised.
Pediatric use
Not recommended for patients under 18 years of age due to a lack of safety and efficacy data.
Geriatric use
No dose adjustment is required for patients aged 65 years or older.
Renal / hepatic impairment
Renal Impairment: No dose adjustment is required.
Hepatic Impairment: No dose adjustment is required for any degree of hepatic impairment.
Overdose effects
Overdose can lead to excessive erythropoiesis (polycythemia). If hemoglobin exceeds 13 g/dL, temporarily withhold the drug. If clinically indicated, phlebotomy may be performed.
Storage conditions
Store in the refrigerator at 2°C to 8°C. Keep the pre-filled syringe in the outer carton to protect from light. Do not freeze. Can be stored at room temperature (below 30°C) for a single period of up to 1 month.
Chemical structure
Methoxy Polyethylene Glycol-Epoetin Beta