Methoxy Polyethylene Glycol-Epoetin Beta: uses, dosing, side effects & brands
Methoxy Polyethylene Glycol-Epoetin Beta is a medicine sold in the U.S. under one brand, for anemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Anemia
- Available as
- Injectable
- Sold as
- Mircera
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How methoxy polyethylene glycol-epoetin beta is dosed
From the FDA label for Mircera (application BLA125164). Other methoxy polyethylene glycol-epoetin beta products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Mircera is administered by subcutaneous or intravenous injection ( 2.2 ). Adult Patients • Initial Treatment: (patients not currently treated with an ESA): • CKD patients on dialysis: 0.6 mcg/kg body weight administered once every two weeks ( 2.2 ). • CKD patients not on dialysis: 1.2 mcg/kg body weight administered once every month as a single subcutaneous injection. Alternatively, a starting dose of 0.6 mcg/kg body weight may be administered once every two weeks as a single intravenous or subcutaneous injection ( 2.2 ). • Conversion from Another ESA: • Dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion ( 2.2 ). Pediatric Patients • Conversion from another ESA: dosed once every 4 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion ( 2.2 ). • In patients less than 6 years of age, maintain the same route of administration as the previous ESA when switching from another ESA to Mircera. 2.1 Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.…
Methoxy Polyethylene Glycol-Epoetin Beta side effects
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions ( 5.1 )] • Increased Mortality and/or Tumor Progression in Patients with Cancer [see Warnings and Precautions ( 5.2 )] • Hypertension [see Warnings and Precautions ( 5.3 )] • Seizures [see Warnings and Precautions ( 5.4 )] • Pure Red Cell Aplasia [see Warnings and Precautions ( 5.6 )] • Serious Allergic Reactions [see Warnings and Precautions ( 5.7 )] • Severe Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] The most common adverse reactions (≥ 10%) are hypertension, diarrhea, nasopharyngitis ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Vifor (International) Inc. at 1-800-576-8295, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of Mircera cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. Adult Patients The data described below reflect exposure to Mircera in 2737 patients, including 1451 exposed for 6 months and 1144 exposed for greater than one year. Mircera was studied primarily in active-controlled studies (n=1789…
Who shouldn’t take methoxy polyethylene glycol-epoetin beta
Mircera is contraindicated in patients with: • Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )] • Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )] • History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria) [see Warnings and Precautions ( 5.7 , 5.8 )] . • Uncontrolled hypertension ( 4 ). • Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs ( 4 ). • History of serious allergic reactions to Mircera, including anaphylaxis ( 4 ).
Every methoxy polyethylene glycol-epoetin beta product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Mircera.
What people report to the FDA about methoxy polyethylene glycol-epoetin beta
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,020 reports naming methoxy polyethylene glycol-epoetin beta, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- hypertension75 reports
- haemoglobin decreased59 reports
- pneumonia57 reports
- anaemia52 reports
- cardiac failure41 reports
- sepsis35 reports
- fall31 reports
- renal impairment30 reports
Read these as a signal, not a rate. A report does not mean methoxy polyethylene glycol-epoetin beta caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
What is methoxy polyethylene glycol-epoetin beta?
Methoxy polyethylene glycol-epoetin beta, is an ESA which differs from erythropoietin through formation of a chemical bond between either the N-terminal amino group or the ε-amino group of any lysine present in erythropoietin, predominantly Lys 52 and Lys 45 , and methoxy polyethylene glycol (PEG) butanoic acid (approximately 30,000 daltons).
Can you take methoxy polyethylene glycol-epoetin beta with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run methoxy polyethylene glycol-epoetin beta against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does methoxy polyethylene glycol-epoetin beta come in?
Across the brands we track, methoxy polyethylene glycol-epoetin beta is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic methoxy polyethylene glycol-epoetin beta?
We do not currently list a generic-labelled methoxy polyethylene glycol-epoetin beta product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Methoxy Polyethylene Glycol-Epoetin Beta: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/methoxy-polyethylene-glycol-epoetin-beta
- MLA
- “Methoxy Polyethylene Glycol-Epoetin Beta: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/methoxy-polyethylene-glycol-epoetin-beta.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for methoxy polyethylene glycol-epoetin beta on DailyMed (NIH) ↗ — including its boxed warning in full.