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Epogen Side Effects

Generic name: epoetin alfa

Medically reviewed by Drugs.com. Last updated on Oct 24, 2024.

Note: This document provides detailed information about Epogen Side Effects associated with epoetin alfa. Some dosage forms listed on this page may not apply specifically to the brand name Epogen.

Applies to epoetin alfa: injection solution.

Important warnings This medicine can cause some serious health issues

Injection route (solution)

Erythropoiesis-stimulating agents (ESAs) increase the risks for death, myocardial infarction, stroke, and other serious cardiovascular events.

In patients with chronic kidney disease (CKD), patients are at a greater risk for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target Hb levels of 11 g/dL and above.

No clinical trial has identified an Hb target level, ESA dose, or dosing strategy that does not increase these risks; use at lowest sufficient dose is recommended.

In cancer patients with certain tumor types (ie, breast, non-small cell lung, head and neck, lymphoid, cervical), ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies.

In patients with cancer, use the lowest ESA dose needed to avoid RBC transfusions and serious cardiovascular and thromboembolic reactions.

Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy, and discontinue following the completion of a chemotherapy course.

Patients receiving myelosuppressive chemotherapy should not be treated with ESAs when the anticipated outcome is cure. Deep venous thrombosis prophylaxis should be considered when epoetin alfa is used preoperatively.

Precautions

It is very important that your doctor check the blood of you or your child on a regular basis while you are using this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away. .

Do not use this medicine if you or your child have had an allergic reaction to albumin or products derived from human or animal cells.

This medicine contains benzyl alcohol which may cause serious reactions to newborn or premature infants. Discuss this with your doctor if you are concerned.

Epoetin sometimes causes seizures, especially during the first 90 days of treatment. During this time, it is best to avoid driving, using heavy machinery, or doing other activities that could cause serious injury if a seizure occurs while you are performing them.

People with severe anemia usually feel very tired and sick. When epoetin begins to work, usually in about 6 weeks, most people start to feel better. Some people are able to be more active. However, epoetin only corrects anemia. It has no effect on kidney disease, cancer, or any other medical problem that needs regular medical attention. Even if you or your child are feeling much better, it is very important that you do not miss any appointments with your doctor or any dialysis treatments. .

This medicine may increase your risk of having serious heart and blood vessel problems, such as congestive heart failure, heart attacks, or stroke. Check with your doctor right away if you or your child start having dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking. .

This medicine may increase your risk of having blood clots. This is more likely in patients who use high doses of this medicine, or who use this medicine before a major surgery. Call your doctor right away if you have chest pain, trouble breathing, or pain, redness, or swelling in your arms or legs while using this medicine. If you are getting dialysis treatments, tell your doctor right away if you notice blood clots at the injection site. Your doctor may give you a blood thinner before surgery to help prevent blood clots.

This medicine may cause blood clots to form in the access port (A-V shunt) for patients with chronic kidney disease who receive dialysis treatments. This would cause the access port to stop working. Tell your doctor right away if you or your child see blood clots forming in the access port.

When used in patients with certain types of cancer (eg, breast, cervix, lymphoid, lung, head, or neck cancer), this medicine has shortened survival time and worsened the tumor or cancer in some patients. If you or your child are concerned about this, talk with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Epoetin is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns.

Many people with kidney problems need to be on a special diet. Also, people with high blood pressure (which may be caused by kidney disease or by epoetin treatment) may need to be on a special diet or to take medicine to keep their blood pressure under control. After their anemia has been corrected, some people feel so much better that they want to eat more than before. To keep your kidney disease or your high blood pressure from getting worse, it is very important that you or your child follow your special diet and take your medicines regularly, even if you are feeling better.

In addition to epoetin, your body needs iron and vitamins to make red blood cells. Your doctor may direct you or your child to take iron or vitamin supplements. Be sure to follow your doctor's orders carefully. Epoetin will not work properly if there is not enough iron or vitamins in your body.

Serious side effects of Epogen

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 side effects

  • chest pain
  • fever
  • headache
  • increased blood pressure
  • swelling of the face, fingers, ankles, feet, or lower legs
  • weight gain

Less common side effects

  • anxiety
  • blurred vision
  • change in skin color
  • change in vision
  • cough
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • migraine headache
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, tenderness, or swelling of the foot or leg
  • pain in the chest, groin, or legs, especially calves of the legs
  • pale skin
  • partial or complete loss of vision in the eye
  • seizures
  • severe headache of sudden onset
  • skin rash or hives
  • slurred speech
  • sore throat
  • sudden and severe inability to speak
  • sudden loss of coordination
  • sweating
  • temporary blindness
  • tenderness, pain, swelling, warmth, or skin discoloration at the injection site
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vision problems
  • vomiting
  • weakness in the arm or leg on one side of the body, sudden and severe

Incidence not known

  • blistering, peeling, or loosening of the skin
  • chills
  • diarrhea
  • itching
  • joint or muscle pain
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips

Other side effects of Epogen

Some side effects of epoetin alfa 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 side effects

  • bone or joint pain
  • constipation
  • general feeling of tiredness or weakness
  • heartburn or belching
  • itching or stinging at the injection site
  • loss of strength or energy
  • muscle aches or weakness
  • shivering
  • skin pain
  • stomach discomfort, upset, pain, or swelling
  • weight loss

For healthcare professionals

Applies to epoetin alfa: injectable solution.

General adverse events

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

Gastrointestinal

Other

Nervous system

Cardiovascular

Respiratory

Dermatologic

Musculoskeletal

Local

Metabolic

Psychiatric

Hematologic

Immunologic

See also:

References

1. (2002) "Product Information. Epogen (epoetin alfa)." Amgen

2. (2002) "Product Information. Procrit (epoetin alfa)." Ortho Biotech Inc

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

4. Cerner Multum, Inc. "Australian Product Information."

Frequently asked questions

Further information

Epogen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.