Prescription medicine

Methoxy polyethylene glycol-epoetin beta Brand names: Mircera

Methoxy polyethylene glycol-epoetin beta (Mircera) is a prescription medicine with an FDA approval on record since 2007. No generic is listed in FDA's NDC Directory.

No generic listed
Boxed warning

Check it at the source: the methoxy polyethylene glycol-epoetin beta FDA label on DailyMed (effective August 14, 2026, Vifor (International) Inc.); the BLA 125164 record on Drugs@FDA; every methoxy polyethylene glycol-epoetin beta label on DailyMed.

Highlights of the record

FDA label of August 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning Chronic Kidney Disease:

In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL ( 5.1 ).

No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks ( 5.1 ).

Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions ( 5.1 ). Cancer:

Mircera is not indicated and is not recommended for the treatment of anemia due to cancer chemotherapy. A dose-ranging study of Mircera was terminated early because of more deaths among patients receiving Mircera than another ESA ( 5.2 ).

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers ( 5.2 ). […]

Used for

From the label: indications and usage
Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in:
adult patients on dialysis and adult patients not on dialysis ( 1.1 ).

Forms and strengths

0.3ml
0.6ml

Injection (solution).

On the market

Earliest approval on file: November 14, 2007 Mircera, Hoffman-La Roche; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 10,973 through July 30, 2026

What is methoxy polyethylene glycol-epoetin beta used for?

From the label: indications and usage
Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in:
adult patients on dialysis and adult patients not on dialysis ( 1.1 ).
pediatric patients 3 months to 17 years of age on dialysis or not on dialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA ( 1.1 ). Limitations of Use Mircera is not indicated and is not recommended for use:
In the treatment of anemia due to cancer chemotherapy ( 5.2 ).
As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 12.2 ). […]

Conditions named in the indications of methoxy polyethylene glycol-epoetin beta's FDA labels, with every medicine labeled for each:

Anemia

FDA pharmacologic class: Erythropoiesis-stimulating Agent.

Source: FDA drug label (Mircera), BLA125164 (Hoffman-La Roche), as published by Vifor (International) Inc., effective August 14, 2026 (SPL set 22c56f2a-f73c-60e7-e054-00144ff88e88), via openFDA; the full label on DailyMed

What does the patient leaflet for methoxy polyethylene glycol-epoetin beta say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about Mircera?
Mircera may cause serious side effects that can lead to death, including: For people with cancer: Mircera is not for use to treat anemia that is caused by cancer chemotherapy. If you have certain cancers, your tumor may grow faster, and you may die sooner if you take Mircera. For people with anemia from chronic kidney disease (CKD) who take Mircera: • Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with Mircera to increase red blood cells (RBCs) to near the same level found in healthy people. • Blood clots. Blood clots may happen at any time while taking Mircera. Your chance of getting a blood clot that is serious and life threatening is higher if you have cancer. If you are receiving Mircera and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Blood clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus). […]

From the patient leaflet: How should I store Mircera?
Store Mircera prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C). • Do not freeze or shake Mircera. • Keep Mircera in the original carton to protect it from light. • Mircera prefilled syringes may be stored at room temperature up to 77°F (25°C) for no more than 30 days. • Throw away (discard) Mircera after 30 days if it has been stored at room temperature. Keep Mircera and all medicines out of the reach of children.

Is there a generic for methoxy polyethylene glycol-epoetin beta (Mircera)?

No generic methoxy polyethylene glycol-epoetin beta is approved (Drugs@FDA, October 8, 2026).

2007 earliest approval on file

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the methoxy polyethylene glycol-epoetin beta label say about other medicines?

The methoxy polyethylene glycol-epoetin beta label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Darbepoetin alfa	warnings and precautions	The design and overall results of the 3 large trials comparing higher and lower hemoglobin targets are shown in Table 4 (Normal Hematocrit Study (NHS), Correction of Hemoglobin Outcomes in Renal Insufficiency (CHOIR) and Trial to Reduce Cardiovascular Events with Aranesp ® Therapy (TREAT)).
Epoetin	warnings and precautions	NHS (N = 1265): Population; CHOIR (N = 1432): CKD patients on hemodialysis with coexisting CHF or CAD, hematocrit 30 ± 3% on epoetin alfa; TREAT (N = 4038): CKD patients not on dialysis with hemoglobin less than 11 g/dL not previously administered epoetin alfa; …
Heparin	warnings and precautions	Patients receiving Mircera may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.

Check methoxy polyethylene glycol-epoetin beta against other medicines

What do FAERS reports show for methoxy polyethylene glycol-epoetin beta?

The FDA Adverse Event Reporting System holds 10,973 reports that list methoxy polyethylene glycol-epoetin beta among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,904 are coded as a death and 2,954 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Drug Hypersensitivity2,981
Death (an outcome recorded in the report)1,576
Dyspnoea1,123
Nausea823
Pruritus (named in the label)783
Vomiting (named in the label)682
Haemoglobin Decreased582
Flushing513

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as methoxy polyethylene glycol-epoetin beta?

8 other medicines are given the same way (intravenous) and in the same FDA class as methoxy polyethylene glycol-epoetin beta or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (intravenous)	Pharmacy cost	Shortage
Epoetin	Anemia	none listed	$32.27 per mL 2,000 units/mL vial	No current entry
Darbepoetin alfa	Anemia	none listed	$446.58 per mL 25 mcg/0.42 mL syring	No current entry
Iron sucrose	Anemia	3 labelers	n/a	A presentation being discontinued
Ferumoxytol	Anemia	1 labeler	n/a	No current entry
Sodium ferric gluconate complex	Anemia	1 labeler	n/a	No current entry
Ferric derisomaltose	Anemia	none listed	n/a	No current entry
Imetelstat	Anemia	none listed	n/a	No current entry
Nipocalimab	Anemia	none listed	n/a	No current entry

Every medicine labeled for the same conditions as methoxy polyethylene glycol-epoetin beta

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to methoxy polyethylene glycol-epoetin beta: 8 medicines for the same use
Other erythropoiesis-stimulating agents: the pharmacologic class, with prices and generics
Methoxy polyethylene glycol-epoetin beta side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other