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

A well-studied treatment

given to more than
2.8 million people*

on dialysis with anemia

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Patient with anemia due to CKD participating in a leisure activity

Your doctor will determine the right Hb level for you and treat you with the smallest dose of EPOGEN® needed to help avoid blood transfusion.

What is EPOGEN®?

EPOGEN® has been prescribed for patients like you for more than 30 years. Here’s how it works.

EPOGEN® is a prescription medicine for people on dialysis with anemia due to CKD that acts like a hormone called erythropoietin (ee-rith-row-PO-eh-tin). This hormone plays an important role in making red blood cells. EPOGEN® is used to treat anemia by helping the body create more red blood cells.

When the amount of blood cells are lower than normal, you also have decreased levels of hemoglobin (also called Hb). Hb is the iron-rich protein that allows the red blood cells to carry oxygen from your lungs to the rest of your body. Less Hb means less oxygen to your tissues and organs—like your heart and your brain—so they might not get enough oxygen to function properly.

It's important for your doctor to monitor your Hb levels regularly to ensure they don’t go up too high or too quickly.

EPOGEN® decreases the need for red blood cell transfusions.

Blood transfusions are given for chronic anemia, but transfusions may also have risks, such as different types of reactions and infections.

EPOGEN® increases Hb levels and decreases the need for blood transfusions. EPOGEN® should not be used in place of emergency red blood cell transfusions to treat anemia.

Your doctor will determine the right Hb level for you and treat you with the smallest dose of EPOGEN® needed to help avoid blood transfusion.

Patient with anemia due to CKD walking with a loved one

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

Other potential benefits

EPOGEN® may improve your exercise tolerance and allow you to function better physically.

In a clinical study, patients on hemodialysis with anemia showed improvement in exercise tolerance and in patient-reported physical functioning after taking EPOGEN® for 2 months.

Patients showed improvement in the number of minutes walked on a treadmill. During the test, the treadmill increased in speed and steepness the longer the patient walked.

Patient-reported improvements in overall physical function included:

  • Getting around
  • Walking
  • Movements needed to take care of oneself

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

Patient with anemia due to CKD participating with another person in a leisure activity

How EPOGEN® is given

With EPOGEN®, your doctor can use precise dosing to help manage anemia.

EPOGEN® is given 3 times a week for patients on dialysis.

  • If prescribed by your doctor, your EPOGEN® treatment will probably be on the same schedule as your dialysis
  • EPOGEN® needs to be injected either into your skin or directly into your dialysis line
  • If you are on hemodialysis, it is recommended that you get EPOGEN® through your dialysis line

How is your EPOGEN® treatment monitored?

It takes time for your body to make new red blood cells and raise your hemoglobin (Hb) level. With EPOGEN® treatment, Hb levels usually increase in 2 to 6 weeks.

Your doctor will test your blood regularly—at least weekly at the beginning of your treatment—to make sure EPOGEN® is working. The test will measure your Hb or your hematocrit (hee-MAT-a-crit) levels, though most doctors measure Hb because it is a better way to check for anemia.

  • Your doctor will determine the right Hb level for you and prescribe the smallest dose of EPOGEN® required to reduce your need for blood transfusions
  • EPOGEN® may be prescribed when your Hb level is less than 10 g/dL
  • Throughout your EPOGEN® treatment, your doctor will also check your iron levels because iron helps your red blood cells carry oxygen. The majority of patients taking EPOGEN® for their anemia require iron therapy
Patient with anemia due to CKD participating in a leisure activity

Ask your doctor about any questions you may have about EPOGEN® or refer to the Medication Guide for more information.

Side effects

What are possible side effects of EPOGEN®?

You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with EPOGEN® to reach a normal or near-normal Hb level. If your Hb level stays too high or goes up too quickly, this may also lead to these serious problems. These problems may happen even if you take EPOGEN® and do not have an increase in your Hb level.

Common side effects of EPOGEN® include:

  • Joint, muscle, or bone pain
  • Fever
  • Cough
  • Rash
  • Nausea
  • Vomiting
  • Soreness of mouth
  • Itching
  • Headache
  • Redness and pain in the skin where EPOGEN® shots were given

These are not all the possible side effects of EPOGEN®. Ask your doctor for a complete list and talk to your doctor about any side effects that bother you or that do not go away.

Before you take EPOGEN®, tell your nurse and doctor about any conditions you have, including if you:

  • Have heart disease
  • Have high blood pressure
  • Have had a seizure (convulsion) or stroke
  • Receive dialysis treatment
  • Are pregnant or plan to become pregnant. It is not known if EPOGEN® may harm your unborn baby. Talk to your healthcare provider about possible pregnancy and birth control choices that are right for you
  • Are breast-feeding or planning to breast-feed. It is not known if EPOGEN® passes into the breast milk

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Ask your doctor about any questions you may have about EPOGEN® or refer to the Medication Guide for more information.

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®.