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Epogen Side Effects

Generic Name: epoetin alfa

Note: This document contains side effect information about epoetin alfa. Some of the dosage forms listed on this page may not apply to the brand name Epogen.

In Summary

Common side effects of Epogen include: upper respiratory tract infection, arthralgia, decreased serum iron, diarrhea, edema, fever, low serum ferritin, paresthesia, respiratory congestion, skin rash, tachycardia, cough, dyspnea, headache, nausea, signs and symptoms of injection site, and vomiting. Other side effects include: chest pain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to epoetin alfa: injection solution

Warning

Injection route (Solution)

ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.Chronic Kidney Disease:In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level greater than 11 g/dL.No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.Use the lowest epoetin alfa-epbx dose sufficient to reduce the need for red blood cell (RBC) transfusions.Cancer:ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.Use ESAs only for anemia from myelosuppressive chemotherapy.ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.Discontinue following the completion of a chemotherapy course.Perisurgery:Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended.

Along with its needed effects, epoetin alfa (the active ingredient contained in Epogen) 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 alfa:

More Common

  • Black, tarry stools
  • blurred vision
  • body aches or pain
  • bone pain
  • chest pain
  • chills
  • cough
  • dizziness
  • dry mouth
  • ear congestion
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • itching, skin rash
  • loss of voice
  • nasal congestion
  • nausea
  • nervousness
  • pain, redness, or swelling in the arm or leg
  • painful or difficult urination
  • pounding in the ears
  • runny nose
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • swollen glands
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • troubled breathing
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting

Less Common

Incidence Not Known

  • Blistering, peeling, or loosening of the skin
  • dark urine
  • diarrhea
  • fluid-filled skin blisters
  • hives
  • joint pain
  • light-colored stools
  • 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
  • sensitivity to the sun
  • skin thinness
  • tightness in the chest
  • yellow eyes or skin

Check with your doctor immediately if any of the following side effects occur while taking epoetin alfa:

More Common

  • Decreased weight
  • difficulty in moving
  • injection site irritation or pain
  • muscle spasm or stiffness
  • swelling or inflammation of the mouth
  • swollen joints
  • trouble sleeping

Less Common

  • Discouragement
  • feeling sad or empty
  • irritability
  • loss of interest or pleasure
  • trouble concentrating

For Healthcare Professionals

Applies to epoetin alfa: injectable solution

General

The most common adverse reaction was dose-dependent increase in blood pressure or aggravation of existing hypertension.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 56%), diarrhea (up to 30%), vomiting (up to 28%), stomatitis (10%)

Common (1% to 10%): Dysphagia

Frequency not reported: Vomiting[Ref]

Other

Very common (10% or more): Pyrexia (up to 42%)

Common (1% to 10%): Chills, influenza-like illness, peripheral edema, artificial kidney clotting during dialysis, edema[Ref]

Nervous system

Very common (10% or more): Headache (up to 34%)

Common (1% to 10%): Convulsion, dizziness

Frequency not reported: Cerebrovascular accident, transient ischemic attack[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 33%), embolism and thrombosis (up to 15%)

Common (1% to 10%): Deep vein thrombosis, thrombosis

Uncommon (0.1% to 1%): Myocardial infarction

Frequency not reported: Blood pressure increased, aneurysm[Ref]

Respiratory

Very common (10% or more): Cough (up to 26%)

Common (1% to 10%): Respiratory tract congestion, upper respiratory tract infection, pulmonary embolism[Ref]

Dermatologic

Very common (10% or more): Rash (up to 25%), pruritus (up to 21%)

Common (1% to 10%): Urticaria

Uncommon (0.1% to 1%): Erythema

Frequency not reported: Angioedema

Postmarketing reports: Severe cutaneous reactions[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 24%), pain in extremity (up to 15%), myalgia (up to 10%)

Common (1% to 10%): Bone pain, muscle spasm

Frequency not reported: Porphyria[Ref]

Local

Very common (10% or more): Injection site reaction (up to 18%), injection site pain (up to 13%)

Common (1% to 10%): Vascular access thrombosis[Ref]

Metabolic

Very common (10% or more): Hyperkalemia (up to 10%)

Common (1% to 10%): Weight decrease, hyperglycemia, hypokalemia[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression[Ref]

Hematologic

Common (1% to 10%): Leukopenia

Postmarketing reports: Erythropoietin antibody-mediated pure red cell aplasia, thrombocytopenia[Ref]

Immunologic

Frequency not reported: Anaphylactic reaction, hypersensitivity

Postmarketing reports: Serious allergic reaction[Ref]

References

1. "Product Information. Epogen (epoetin alfa)." Amgen, Thousand Oaks, CA.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. "Product Information. Procrit (epoetin alfa)." Ortho Biotech Inc, Raritan, NJ.

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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