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Epoetin beta-methoxy polyethylene glycol Side Effects

For the Consumer

Applies to epoetin beta-methoxy polyethylene glycol: injection solution

Along with its needed effects, epoetin beta-methoxy polyethylene glycol 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 or nurse 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 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 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
  • 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. 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.

Some side effects of epoetin beta-methoxy polyethylene glycol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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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