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Mircera Side Effects

Generic Name: epoetin beta-methoxy polyethylene glycol

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

In Summary

Common side effects of Mircera include: death. Other side effects include: upper respiratory tract infection. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to epoetin beta-methoxy polyethylene glycol: injection solution

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 .

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
  • 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
  • tightness in the chest
  • vision changes
  • vomiting
  • weight gain

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

  • 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]

References

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

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.

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