Methoxy Polyethylene Glycol Epoetin Beta
Pronunciation: meh-THOK-see pol-ee-ETH-uh-leen GLY-col ee-POE-e-tin BAY-tuh.
- Generic name
- Methoxy polyethylene glycol-epoetin beta
- Brand names
- Epotin-M, Mircera, Renocel
- Drug class
- Erythropoiesis-stimulating agent (ESA)
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What Methoxy polyethylene glycol-epoetin beta is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Methoxy polyethylene glycol-epoetin beta works
Methoxy polyethylene glycol-epoetin beta is a continuous erythropoietin receptor activator (CERA). It binds to and activates the erythropoietin receptor on erythroid progenitor cells in the bone marrow, stimulating erythropoiesis (red blood cell production). The polyethylene glycol modification prolongs its half-life, allowing for less frequent dosing compared to other ESAs. (1)
What Methoxy polyethylene glycol-epoetin beta is used for
Anemia associated with chronic kidney disease (CKD)
Anemia associated with chronic kidney disease (CKD) (2)
Anemia in adult patients with chronic kidney disease (CKD) who are not on dialysis
Anemia in adult patients with chronic kidney disease (CKD) who are not on dialysis (2)
Anemia in adult patients with chronic kidney disease (CKD) who are on dialysis
Anemia in adult patients with chronic kidney disease (CKD) who are on dialysis (2)
Anemia in pediatric patients with CKD (3 months to 17 years) converting from another ESA
Approved for children who are switching from another erythropoiesis-stimulating agent after their hemoglobin has been stabilized on that agent — not for starting ESA treatment in children for the first time. Not present in the clinician database record; added from the current FDA label. (2)
Before taking Methoxy polyethylene glycol-epoetin beta
Do not take / not appropriate for
- uncontrolled hypertension, known hypersensitivity to the drug or its excipients, and history of pure red cell aplasia following ESA therapy. (Contraindication) (2)
Tell your clinician about
(2)How to take Methoxy polyethylene glycol-epoetin beta
- General Instructions: Use exactly as prescribed by your healthcare provider. Do not change your dose or schedule without consulting your doctor.. Adult Dosing: The starting dose and frequency depend on your hemoglobin level, weight, and whether you are on dialysis. For CKD patients on dialysis: 0.6 mcg/kg (micrograms per kilogram — note this is 1,000 times smaller than a milligram dose) by IV or subcutaneous injection once every 2 weeks. For CKD patients not on dialysis: either 1.2 mcg/kg subcutaneously once monthly, or 0.6 mcg/kg by IV or subcutaneous injection once every 2 weeks. Dose is adjusted based on hemoglobin response.. Pediatric Dosing: Approved for children 3 months to 17 years with CKD-associated anemia who are converting from another erythropoiesis-stimulating agent after their hemoglobin has been stabilized on that other agent — not for starting treatment in children for the first time. Use only under specialist supervision.. Administration: Given as a subcutaneous (under the skin) or intravenous (into a vein) injection. Your healthcare provider may teach you or a caregiver how to give injections at home.. When To Stop: Reasons a clinician may stop or pause treatment include severe hypertension, allergic reactions, or hemoglobin exceeding target levels — always let your doctor make this decision.. Storage: Store in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light, keeping it in its original carton. If needed, it may be kept at room temperature (up to 25°C/77°F) for a maximum of 30 days. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take an extra dose to make up for the missed one. Contact your healthcare provider for guidance.
Overdose
Seek emergency medical attention if you suspect an overdose. Symptoms may include dangerously high blood pressure, headache, or risk of blood clots. Supportive care and monitoring are required. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Hypertension
Incidence: Reported in the clinician-authored database; frequency not established
Thrombosis
Incidence: Reported in the clinician-authored database; frequency not established
Injection site reactions
Incidence: Reported in the clinician-authored database; frequency not established
Headache
Incidence: Reported in the clinician-authored database; frequency not established
Diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Peripheral edema
Incidence: Reported in the clinician-authored database; frequency not established
Antibody formation
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
FDA BOXED WARNING — serious
Symptoms: FDA BOXED WARNING: Erythropoiesis-stimulating agents (ESAs) such as Mircera increase the risk of death, myocardial infarction (heart attack), stroke, venous thromboembolism (blood clots), thrombosis of vascular access, and tumor progression or recurrence. In controlled trials, patients had a greater risk of death and serious cardiovascular events when treated to a hemoglobin target above 11 g/dL — no hemoglobin target, dose, or dosing strategy has been shown to avoid these risks. The lowest dose that reduces the need for red blood cell transfusion should be used, and hemoglobin should be monitored closely by the treating clinician.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Not for use in patients with cancer-related anemia not due to chronic kidney disease — a dose-ranging study in cancer-chemotherapy-related anemia was stopped early due to increased deaths compared with another ESA — serious
Symptoms: Not for use in patients with cancer-related anemia not due to chronic kidney disease — a dose-ranging study in cancer-chemotherapy-related anemia was stopped early due to increased deaths compared with another ESA. Can cause or worsen high blood pressure. Rare risk of pure red cell aplasia (PRCA).
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database and confirmed by the FDA label — serious
Symptoms: Contraindications recorded in the clinician database and confirmed by the FDA label: uncontrolled hypertension, history of serious allergic reactions to the drug (including anaphylaxis), and history of pure red cell aplasia following ESA therapy. Use with caution in patients with a history of seizures, cardiovascular disease, or thromboembolic events. Monitor for rapid increases in hemoglobin, as this increases the risk of adverse cardiovascular outcomes.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Methoxy polyethylene glycol-epoetin beta may interact with other drugs that affect blood pressure, anticoagulants, or other erythropoiesis-stimulating agents. Iron supplements may be needed to support red blood cell production. Always inform your healthcare provider of all medications and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Human pregnancy data are limited. Animal studies showed bone malformations, but only at doses 17-fold or more higher than the recommended human dose. Discuss individual risks and benefits with your healthcare provider if you are pregnant or planning pregnancy. (2)
Breastfeeding
There is no data on whether Mircera passes into human breast milk, though erythropoietin occurs naturally in breast milk. The developmental and health benefits of breastfeeding should be weighed against the mother's need for treatment and any potential risk to the infant; discuss with your healthcare provider. (2)
Children
Approved for children 3 months to 17 years of age with CKD-associated anemia who are converting from another erythropoiesis-stimulating agent after their hemoglobin has been stabilized on that agent. Not approved for starting ESA treatment in children for the first time. Use only under specialist supervision. (2)
Renal_impairment
This medicine treats anemia caused by chronic kidney disease, so its dose is already built around the degree of kidney impairment via the on-dialysis and not-on-dialysis dosing schedules on this page, rather than a separate reduced-dose table. For liver impairment, an FDA-reviewed study of people with severe (Child-Pugh Class C) liver impairment found the medicine's single-dose behavior in the body was unchanged compared with healthy volunteers, so no starting-dose adjustment is needed for liver disease. Discuss your specific kidney and liver status with the clinician managing your treatment, since ongoing dose adjustments are guided by your hemoglobin response. (2)
Hepatic_impairment
This medicine treats anemia caused by chronic kidney disease, so its dose is already built around the degree of kidney impairment via the on-dialysis and not-on-dialysis dosing schedules on this page, rather than a separate reduced-dose table. For liver impairment, an FDA-reviewed study of people with severe (Child-Pugh Class C) liver impairment found the medicine's single-dose behavior in the body was unchanged compared with healthy volunteers, so no starting-dose adjustment is needed for liver disease. Discuss your specific kidney and liver status with the clinician managing your treatment, since ongoing dose adjustments are guided by your hemoglobin response. (2)
Monitoring
(2)Storage
Store in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light, keeping it in its original carton. If needed, it may be kept at room temperature (up to 25°C/77°F) for a maximum of 30 days. Keep out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General (US FDA label)
Indication: Anemia associated with chronic kidney disease (CKD), on dialysis
Dose summary: 0.6 mcg/kg (NOT mg/kg — the clinician database's top-level dosing field originally stated 'mg/kg', a 1,000-fold unit error inconsistent with the record's own administration text; corrected here to mcg/kg per the FDA label) by IV or subcutaneous injection once every 2 weeks. Initiate when hemoglobin <10 g/dL; reduce or interrupt if hemoglobin approaches or exceeds 11 g/dL.
Renal context: This medicine is dosed specifically according to dialysis status (see the on-dialysis and not-on-dialysis regimens on this page), which is the FDA label's built-in accommodation for the degree of renal impairment — no separate numeric renal-impairment dose-reduction table exists beyond that split, since anemia of CKD is the treated condition itself. Separately, the FDA label reports the pharmacokinetics of methoxy polyethylene glycol-epoetin beta were not altered by dialysis status, age (6-89 years), sex, race, or severe (Child-Pugh Class C) hepatic impairment; no starting-dose adjustment is necessary for hepatic impairment. (1) (2)
General (US FDA label)
Indication: Anemia associated with chronic kidney disease (CKD), not on dialysis
Dose summary: Either 1.2 mcg/kg subcutaneously once monthly, or 0.6 mcg/kg by IV or subcutaneous injection once every 2 weeks. Consider initiating only when hemoglobin <10 g/dL with a risk of needing a transfusion; reduce or interrupt if hemoglobin exceeds 10 g/dL.
Renal context: Dosing for this indication is already split by dialysis status, which is how the FDA label accounts for the degree of kidney disease being treated — there is no additional numeric renal-dose-reduction table beyond the regimens given here. In a dedicated study, single-dose pharmacokinetics were unchanged in patients with severe (Child-Pugh Class C) hepatic impairment compared with healthy volunteers, so no starting-dose adjustment is necessary for hepatic impairment. (2)
Frequently asked questions
What is methoxy polyethylene glycol-epoetin beta used for?
It is used to treat anemia in adults with chronic kidney disease, both on dialysis and not on dialysis, by stimulating the production of red blood cells.
How is methoxy polyethylene glycol-epoetin beta administered?
It is given as an injection under the skin (subcutaneous) or into a vein (intravenous), usually by a healthcare provider or trained caregiver.
What should I do if I miss a dose?
Take the missed dose as soon as you remember, unless it is almost time for your next scheduled dose. Do not take an extra dose to make up for the missed one. Contact your healthcare provider for advice.
What are the most common side effects?
Common side effects include headache, muscle pain, diarrhea, nausea, vomiting, and injection site reactions.
Can this medication cause high blood pressure?
Yes, it can increase or worsen high blood pressure. Regular monitoring is important.
Is it safe during pregnancy or breastfeeding?
Human pregnancy data are limited, and animal studies only showed bone malformations at doses far higher than the human dose. There is no data on whether it passes into breast milk, though erythropoietin occurs naturally in breast milk. Discuss your individual situation with your healthcare provider.
Do I need regular blood tests while on this medication?
Yes, regular blood tests are necessary to monitor hemoglobin levels and ensure safe and effective treatment.
What happens if I take too much Methoxy polyethylene glycol-epoetin beta?
Taking too much Methoxy polyethylene glycol-epoetin beta can lead to an excessive increase in red blood cell count, potentially causing serious cardiovascular events such as blood clots, heart attack, or stroke. If an overdose is suspected, it is crucial to seek immediate emergency medical attention to manage symptoms and prevent severe complications.
Can I drink alcohol while taking Methoxy polyethylene glycol-epoetin beta?
While there isn't a direct contraindication for alcohol consumption with Methoxy polyethylene glycol-epoetin beta, excessive alcohol intake can negatively impact overall health and liver function, which may indirectly affect the body's response to the medication or worsen underlying conditions. It is always best to discuss alcohol consumption with your healthcare provider.
Is Methoxy polyethylene glycol-epoetin beta safe during pregnancy?
Methoxy polyethylene glycol-epoetin beta's safety during pregnancy is not definitively established, and it falls under a pregnancy category that requires careful consideration. It is imperative for pregnant individuals or those planning pregnancy to consult their doctor to weigh the potential benefits against any risks to the fetus before using this medication.
What is the mechanism of action of Methoxy polyethylene glycol-epoetin beta?
Methoxy polyethylene glycol-epoetin beta is a continuous erythropoietin receptor activator (CERA). It binds to and activates the erythropoietin receptor on erythroid progenitor cells in the bone marrow, stimulating erythropoiesis (red blood cell production). The polyethylene glycol modification prolongs its half-life, allowing for less frequent dosing compared to other ESAs. (1)
What is the generic name of Methoxy Polyethylene Glycol Epoetin Beta?
The generic name is Methoxy polyethylene glycol-epoetin beta. It is sold under brand names including Epotin-M, Mircera, Renocel.
What class of drug is Methoxy polyethylene glycol-epoetin beta?
Methoxy Polyethylene Glycol Epoetin Beta is classed as: Erythropoiesis-stimulating agent (ESA).
References
- Methoxy polyethylene glycol-epoetin beta — clinician-authored medicine recordMedGuideGlobal · Global · accessed 2026-08-06 · source 1
- MIRCERA (methoxy polyethylene glycol-epoetin beta) injection, solution — prescribing informationU.S. Food and Drug Administration · United States · accessed 2026-08-06 · source 2
- Methoxy Polyethylene Glycol-Epoetin Beta Injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Methoxy polyethylene glycol-epoetin beta — RxNorm normalized drug concept (RXCUI 729596)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 4
Brand names by country
Single-ingredient Methoxy polyethylene glycol-epoetin beta names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Mircera150 ug/.3mL, 30 ug/.3mL, 50 ug/.3mL, 250 ug/.3mL, 120 ug/.3mL, 200 ug/.3mL, 75 ug/.3mL, 100 ug/.3mL · vifor (international) inc.