Mircera Side Effects

Generic name: epoetin beta-methoxy polyethylene glycol

Medically reviewed by Drugs.com. Last updated on May 17, 2024.

Note: This document provides detailed information about Mircera Side Effects associated with epoetin beta-methoxy polyethylene glycol. Some dosage forms listed on this page may not apply specifically to the brand name Mircera.

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

Important Warnings This medicine can cause some serious health issues

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

• blurred vision
• body aches or pain
• chills
• confusion
• cough
• difficulty with breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• nervousness
• pounding in the ears
• runny nose
• slow or fast heartbeat
• sneezing
• sore throat
• sweating
• unusual tiredness or weakness

Less common

• bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain
• pains in the chest, groin, or legs, especially the calves of the legs
• severe headaches of sudden onset
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes

Incidence not known

• blistering, peeling, or loosening of the skin
• chest tightness
• confusion
• decreased urine output
• diarrhea
• difficulty with speaking
• difficulty with swallowing
• dilated neck veins
• double vision
• extreme tiredness or weakness
• fast, pounding, or irregular heartbeat or pulse
• hives or welts, itching, or skin rash
• inability to move the arms, legs, or facial muscles
• inability to speak
• irregular breathing
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• pain or discomfort in the arms, jaw, back, or neck
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin
• seizures
• severe, sudden headache
• slow or slurred speech
• sores, ulcers, or white spots in the mouth or on the lips
• sudden, severe weakness or numbness in the arm or leg
• sweating
• swelling of the face, fingers, feet, or lower legs
• vision changes
• vomiting
• weight gain

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

• back pain
• muscle spasms

Less common

• difficulty having a bowel movement

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]

Further information

Mircera side effects can vary depending on the individual. 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.

Medical Disclaimer