Epoetin beta-methoxy polyethylene glycol Side Effects

Please note - some side effects for 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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects by Body System

Cardiovascular

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

Gastrointestinal

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

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%).

Respiratory

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

Genitourinary

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

Nervous system

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

Musculoskeletal

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

Other

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

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.

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.

Hypersensitivity

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

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