Indication

EPOGEN® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease Read More in patients on dialysis to reduce or avoid the need for red blood cell transfusions.

EPOGEN® has not been proven to improve quality of life, fatigue, or well-being.

EPOGEN® should not be used in place of emergency treatment for anemia (red blood cell transfusions).

Important Safety Information Indication Prescribing Information Medication Guide For Healthcare Professionals Contact Us

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Patient with anemia due to CKD

What is anemia?

Anemia is linked to a shortage of red blood cells.

Every part of the body needs oxygen to work and survive. Red blood cells have the important job of carrying oxygen around the body. When the body has fewer healthy red blood cells than normal, anemia develops.

Illustration indicating fewer red blood cells and normal number of red blood cells Illustration indicating fewer red blood cells and normal number of red blood cells

When you have anemia, your body does not get enough oxygen, so it has to work harder to do all of its jobs—like making the heart beat and the muscles move.

  • If you have anemia, you may find it harder to do physical activities like walking or climbing stairs, or daily tasks like getting ready in the morning or carrying groceries
  • Anemia has other symptoms too. Talk with your dialysis care team about how you’re feeling
Patient with anemia due to CKD interacting with a loved one

What causes anemia?

How does chronic kidney disease cause anemia?

Anemia has many causes. If your doctor has diagnosed you with anemia due to chronic kidney disease (CKD), it means your kidneys are not making enough of the hormone erythropoietin (ee-rith-row-PO-eh-tin).

Erythropoietin is the hormone made by the kidneys that tells your body to create red blood cells.

Healthy kidneys

Illustration indicating how healthy kidneys make enough erythropoietin to produce a normal number of red blood cells Illustration indicating how healthy kidneys make enough erythropoietin to produce a normal number of red blood cells

Damaged kidneys

Illustration indicating how damaged kidneys do not make enough erythropoietin, resulting in fewer red blood cells Illustration indicating how damaged kidneys do not make enough erythropoietin, resulting in fewer red blood cells

During treatment for chronic kidney disease, your doctor monitors your hemoglobin (Hb) to see if your red blood cell count is low. Hb is the protein found in red blood cells that is responsible for carrying the oxygen your body needs.

Patient with anemia due to CKD participating in a leisure activity

Your doctor will help you choose the best treatment for your anemia.

Treatment options

What is often used to treat anemia in people on dialysis?

Iron supplements

Many patients with chronic kidney disease do not have enough iron. The body needs iron to make red blood cells and carry oxygen.

Erythropoiesis-stimulating agents (ESAs)

ESAs act like erythropoietin, which tells your body to make more red blood cells. Having enough iron is important before and during ESA therapy. An ESA, like EPOGEN®, is available only through your doctor, who will review the risks and benefits of this specific treatment.

Red blood cell transfusions

Transfusion can quickly increase the number of red blood cells within 1 to 4 hours. Your doctor can cover the benefits and risks of transfusion, including the possible reactions and infections that could result.

Your doctor will help you choose the best treatment for your anemia.

Patient with anemia due to CKD interacting with a loved one

What you can do

You can take steps to help manage your anemia.

Your doctor will talk to you about treating your anemia. But there are many things you can do to help manage your anemia, such as:

  • Learn more about chronic kidney disease, anemia, and dialysis
  • Talk with your healthcare team and other patients with anemia
  • Keep all of your dialysis appointments and stay for your full treatment
  • Keep track of your lab test results, particularly your hemoglobin so you can see how your efforts are helping manage your anemia
  • Work with a dietitian to improve your eating habits
  • Take all your medicines as they are prescribed

Talk to your healthcare team

Different healthcare professionals may be involved in your care:

  • Primary care doctor
  • Specialty doctor, such as a nephrologist
  • Dietitian
  • Nurses

By keeping them informed, you can help them provide the best possible care for you. Here are some tips to help you:

  • Before an appointment, think about anything you may want to ask and write it down
  • Talk about any new problems or symptoms, especially if you have changes in how you are feeling
  • Bring a list of changes in any of your medications
  • Be sure to listen carefully and take notes to help you remember instructions for your care
  • Ask questions if you do not understand and make sure all your questions are answered

Important Safety Information

EPOGEN® may cause serious side effects that can lead to death, including:

For people with cancer:

  • In patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers: Your tumor may grow faster and you may die sooner if you choose to take EPOGEN®.
  • Your healthcare provider will talk with you about these risks.

For all people who take EPOGEN®, including people with cancer or chronic kidney disease:

  • Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with EPOGEN® to increase red blood cells (RBCs) to near the same level found in healthy people.
  • Blood clots. Blood clots may happen at any time while taking EPOGEN®. If you are receiving EPOGEN® for any reason and are going to have surgery, talk with your healthcare provider about whether you need to take a blood thinner to lessen the chance of blood clots during or following surgery.
  • Call your healthcare provider or get medical help right away if you have any of these symptoms:
    • Chest pain
    • Trouble breathing or shortness of breath
    • Pain or swelling in your legs
    • A cool or pale arm or leg
    • Sudden confusion, trouble speaking, or trouble understanding others’ speech
    • Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
    • Sudden trouble seeing
    • Sudden trouble walking, dizziness, loss of balance or coordination
    • Loss of consciousness (fainting)
    • Hemodialysis vascular access stops working

If you decide to take EPOGEN®, your healthcare provider should prescribe the smallest dose that is necessary to reduce your chance of needing RBC transfusions.

If your hemoglobin level stays too high or goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take EPOGEN®, even if you do not have an increase in your hemoglobin level.

Do not take EPOGEN® if you:

  • Have cancer and have not been counseled by your healthcare provider about treatment with EPOGEN®.
  • Have high blood pressure that is not controlled (uncontrolled hypertension).
  • Have been told by your healthcare provider that you have, or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with EPOGEN® or other erythropoietin medicines.
  • Have had a serious allergic reaction to EPOGEN®.

Pregnant women, breastfeeding women, and babies should not receive EPOGEN® from multidose vials.

Before taking EPOGEN®, tell your healthcare provider if you: have heart disease; have high blood pressure; have had a seizure or stroke; receive dialysis; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed.

EPOGEN® may cause other serious side effects:

  • High blood pressure. High blood pressure is a common side effect of EPOGEN® in people with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medication while taking EPOGEN®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often.
  • Seizures. If you have seizures while taking EPOGEN®, get medical help right away and tell your healthcare provider.
  • Antibodies to EPOGEN®. Your body may make antibodies to EPOGEN® that can block or lessen your body’s ability to make RBCs and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking EPOGEN®.
  • Serious allergic reactions. Serious allergic reactions can cause a skin rash, itching, shortness of breath, wheezing, dizziness and fainting due to a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using EPOGEN® and call your healthcare provider or get medical help right away.
  • Severe skin reactions. Signs and symptoms of severe skin reactions with EPOGEN® may include: skin rash with itching, blisters, skin sores, peeling, or areas of skin coming off. If you have any signs or symptoms of a severe skin reaction, stop using EPOGEN® and call your healthcare provider or get medical help right away.
  • Dangers of using EPOGEN® from multiple-dose vials (which contain benzyl alcohol) in newborns, infants, and pregnant or breastfeeding women. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. If you use EPOGEN® from multiple-dose vials you should not breastfeed for at least 2 weeks after the last dose.

Common side effects of EPOGEN® include:

  • Joint, muscle, or bone pain
  • Fever
  • Cough
  • Rash
  • Nausea
  • Dizziness
  • High blood sugar
  • Low potassium levels in the blood
  • Chills
  • Blood vessel blockage
  • Low white blood cells
  • Vomiting
  • Soreness of mouth
  • Itching
  • Headache
  • Muscle spasm
  • Trouble sleeping
  • Difficulty swallowing
  • Respiratory infection
  • Weight decrease
  • Depression
  • Redness and pain at the EPOGEN® injection site

These are not all the possible side effects of EPOGEN®. Tell your healthcare provider about any side effects that bother you or do not go away.

You are encouraged to report negative side effects of prescription drugs to the US Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Important Safety Information

EPOGEN® may cause serious side effects that can lead to death, including:

For people with cancer:

  • In patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers: Your tumor may grow faster and you may die sooner if you choose to take EPOGEN®.