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Mircera Side Effects

Generic name: epoetin beta-methoxy polyethylene glycol

Medically reviewed by Drugs.com. Last updated on Aug 18, 2023.

Note: This document contains side effect information about epoetin beta-methoxy polyethylene glycol. Some dosage forms listed on this page may not apply to the brand name Mircera.

Applies to epoetin beta-methoxy polyethylene glycol: injection solution.

Warning

Injection route (Solution)

Erythropoiesis-stimulating agents (ESAs) increase the risk for death, serious adverse cardiovascular reactions, and stroke when administered to target a hemoglobin of greater than 11 g/dL. A hemoglobin target level or dosing strategy that does not increase these risks has not been identified. Use the lowest dose that reduces the need for RBC transfusions. Methoxy polyethylene glycol-epoetin beta is not recommended for treatment of anemia due to cancer chemotherapy. ESAs may shorten overall survival and increase the risk of tumor progression or recurrence in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.

Serious side effects of Mircera

Along with its needed effects, epoetin beta-methoxy polyethylene glycol (the active ingredient contained in Mircera) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking epoetin beta-methoxy polyethylene glycol:

More common

Less common

Incidence not known

Other side effects of Mircera

Some side effects of epoetin beta-methoxy polyethylene glycol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to epoetin beta-methoxy polyethylene glycol: injectable solution.

General

The most common adverse events were hypertension, diarrhea, and nasopharyngitis.[Ref]

Cardiovascular

Very common (10% or more): Hypertension (13%)

Common (1% to 10%): Hypotension, procedural hypotension, arteriovenous fistula thrombosis, arteriovenous fistula site complication, serious hemorrhagic adverse reactions (all types), thrombosis in device

Frequency not reported: Myocardial infarction, congestive heart failure, deep vein thrombosis, thrombotic vascular event[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (11%)

Common (1% to 10%): Vomiting, constipation, gastrointestinal hemorrhage, abdominal pain[Ref]

Hematologic

Common (1% to 10%): Thrombocytopenia

Frequency not reported: Severe anemia[Ref]

Immunologic

Very common (10% or more): Nasopharyngitis (11%)

Common (1% to 10%): Upper respiratory tract infection, urinary tract infection, bronchitis, device related infection, pharyngitis[Ref]

Respiratory

Common (1% to 10%): Cough[Ref]

Other

Common (1% to 10%): Pyrexia

Frequency not reported: Thrombosis of hemodialysis vascular access, death, death adjudicated as cancer[Ref]

Nervous system

Frequency not reported: Stroke, hypertensive encephalopathy, seizures[Ref]

Hypersensitivity

Frequency not reported: Serious allergic reactions (including anaphylaxis, angioedema, bronchospasm, tachycardia, pruritus, skin rash, urticaria)[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms, back pain, pain in extremity[Ref]

Metabolic

Common (1% to 10%): Fluid overload, hyperkalemia[Ref]

Oncologic

Frequency not reported: Tumor progression, decreased locoregional control[Ref]

Dermatologic

Frequency not reported: Severe cutaneous reactions (including Stevens-Johnson syndrome and Toxic Epidermal Necrolysis)[Ref]

References

1. Product Information. Mircera (epoetin beta-methoxy polyethylene glycol). Vifor International Ltd c/o MCT. 2007.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.