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Mircera Side Effects

Generic Name: epoetin beta-methoxy polyethylene glycol

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

Not all side effects for Mircera may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to epoetin beta-methoxy polyethylene glycol: injection solution

In addition to its needed effects, some unwanted effects may be caused by epoetin beta-methoxy polyethylene glycol (the active ingredient contained in Mircera). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking epoetin beta-methoxy polyethylene glycol, check with your doctor or nurse immediately:

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 calves of the legs
  • severe headaches of sudden onset
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sudden vision changes
Incidence not known
  • Confusion
  • decreased urine output
  • difficulty with speaking
  • difficulty with swallowing
  • dilated neck veins
  • double vision
  • extreme fatigue
  • fast, pounding, or irregular heartbeat or pulse
  • hives, itching, or skin rash
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • irregular breathing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • pain or discomfort in the arms, jaw, back, or neck
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • seizures
  • severe, sudden headache
  • slow or slurred speech
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • vision changes
  • vomiting
  • weight gain
  • welts

Some of the side effects that can occur with epoetin beta-methoxy polyethylene glycol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Back pain
  • diarrhea
  • muscle spasms
Less common
  • Difficulty having a bowel movement (stool)

For Healthcare Professionals

Applies to epoetin beta-methoxy polyethylene glycol: injectable solution

Cardiovascular

Cardiovascular side effects including hypertension (13%) and hypotension (5% ) have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including diarrhea (11%), vomiting (6%), and constipation (5%) have been reported.[Ref]

In controlled trials, the rates of serious adverse reactions did not significantly differ between patients receiving epoetin beta-methoxy polyethylene glycol and another erythropoiesis-stimulating agent (ESA) (38% vs. 42%) except for the occurrence of serious gastrointestinal hemorrhage (1.2% vs. 0.2%).[Ref]

Respiratory

Respiratory side effects including nasopharyngitis (11%), upper respiratory tract infection (9% ), and cough (6%) have been reported.[Ref]

Genitourinary

Genitourinary side effects including urinary tract infection (5%) have been reported.[Ref]

Nervous system

Nervous system side effects including headache (9%) have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including muscle spasms (8%), back pain (6%), and pain in extremity (5%) have been reported.[Ref]

Other

Other side effects including procedural hypotension (8%), fluid overload (7%), arteriovenous fistula thrombosis (5%), and arteriovenous fistula site complication 5% have been reported.[Ref]

Immunologic

Compared to SC administration, the IV route of administration may lessen the risk for development of antibodies to epoetin beta-methoxy polyethylene glycol (the active ingredient contained in Mircera) In 1789 patients treated with epoetin beta-methoxy polyethylene glycol in clinical studies, antibody testing using an enzyme-linked immunosorbent assay (ELISA) was conducted at baseline and during treatment. Antibody development was not detected in any of the patients.

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to epoetin beta-methoxy polyethylene glycol with the incidence of antibodies to other ESAs may be misleading.[Ref]

Immunologic side effects including neutralizing antibodies to erythropoietin, in association with pure red cell aplasia (PRCA) or severe anemia (with or without other cytopenias), have been reported in patients receiving other erythropoiesis-stimulating agents (ESAs) during postmarketing experience.[Ref]

Hypersensitivity

Hypersensitivity side effects including tachycardia, pruritus, and rash have been reported.

References

1. "Product Information. Mircera (epoetin beta-methoxy polyethylene glycol)." Roche Laboratories, Nutley, NJ.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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