Epoetin beta-methoxy polyethylene glycol Side Effects

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.

For the Consumer

Applies to epoetin beta-methoxy polyethylene glycol: injectable solution

Contact your doctor if you feel weak, tired, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Epoetin beta-methoxy polyethylene glycol can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• feeling short of breath, even with mild exertion;

• swelling, rapid weight gain;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate; or

• pain or swelling in one or both legs.

Get emergency medical help if you have any of these signs of an allergic reaction while taking epoetin beta-methoxy polyethylene glycol: hives or itchy skin rash; difficulty breathing; fast heart rate; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• seizure (convulsions);

• pain or burning when you urinate; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of epoetin beta-methoxy polyethylene glycol may include:

• stuffy nose, sore throat, cough;

• headache;

• muscle aches, back pain;

• nausea, vomiting, diarrhea, constipation; or

• itching, redness, bruising, or swelling where you injected the medication.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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.

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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