Indication

EPOGEN® (Epoetin alfa) is used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney failure in patients on dialysis. EPOGEN® stimulates the bone marrow to make more red blood cells and lessens the need for red blood cell transfusions. Having more red blood cells raises the hemoglobin level.

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

Important Safety Information

Using EPOGEN® can lead to death or other serious side effects.

All patients, including patients with cancer or chronic kidney failure:
You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with EPOGEN® to a hemoglobin level above 12 g/dL. Serious health problems may happen even if you take EPOGEN® and do not have an increase in your hemoglobin level. Your doctor should monitor your hemoglobin regularly.

You may get blood clots at any time while taking EPOGEN®. If you are going to have surgery, talk to your healthcare provider about whether you will need 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 symptoms of blood clots such as chest pain; trouble breathing or shortness of breath; pain or swelling in your legs; arm or leg feels cool or appears pale; sudden confusion or trouble with speech; sudden numbness or weakness in your face, arm, or leg; sudden trouble seeing; sudden dizziness or trouble with walking or balance; loss of consciousness (fainting); your hemodialysis vascular access stops working.

Patients with cancer:
Your healthcare provider has received special training through the ESA APPRISE Oncology Program in order to prescribe EPOGEN®. Before you can begin to receive EPOGEN®, you must sign the ESA APPRISE Oncology Patient and Healthcare Professional (HCP) Acknowledgement Form to document that your healthcare provider discussed the risks of EPOGEN® with you. When you sign this form, you are stating that you are aware of the risks associated with use of EPOGEN®.

If you have breast, non-small cell lung, head and neck, lymphoid, or cervical cancer, your tumor may grow faster and you may die sooner when EPOGEN® is used experimentally to try to raise your hemoglobin beyond the amount needed to avoid red blood cell transfusion, or if you are taking EPOGEN® and not getting strong doses of chemotherapy. It is not known whether these risks exist when EPOGEN® is given according to the FDA-approved directions for use.

  • Your healthcare provider should prescribe the smallest dose of EPOGEN® to lower the chance of getting red blood cell transfusions
  • After you have finished your chemotherapy course, EPOGEN® treatment should be stopped
You should not take EPOGEN® if you:
  • Have cancer and have not been counseled by your healthcare provider regarding the risks of EPOGEN® and signed the ESA APPRISE Oncology Program Patient and Healthcare Professional (HCP) Acknowledgement Form before you begin to receive 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 allergies to any of the ingredients in EPOGEN®.

Do not give EPOGEN® from multidose vials to premature babies.

Other side effects, which may also be serious, include:
  • High blood pressure in patients with chronic kidney failure. Your blood pressure may go up or be difficult to control with blood pressure medicine 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. Seizures have occurred in patients taking EPOGEN®. If you have a seizure, get medical help right away.
  • Antibodies to EPOGEN®. Your body may make antibodies to EPOGEN® that can block or lessen your body’s ability to make red blood cells and cause you to have severe anemia. Call your healthcare provider if you have signs of anemia such as unusual tiredness, lack of energy, dizziness, or fainting.
  • Serious allergic reactions. Serious allergic reactions can cause a rash over your whole body, shortness of breath, dizziness, and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have such a reaction, stop using EPOGEN® and get medical help right away.
  • Dangers of giving EPOGEN® to premature babies. EPOGEN® from multi-dose vials contains benzyl alcohol and should not be given to premature babies because it can cause death and brain damage.

While you are on EPOGEN®, tell your healthcare provider if you are, or are planning to, become pregnant or breast-feed.

Common side effectsof EPOGEN® in patients with chronic kidney failure include: high blood pressure, headache, joint pain, nausea, rash, swelling in legs and arms, and injection site reaction, including irritation and pain.

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

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