Important Information about EPOGEN®
Indication
EPOGEN® (epoetin alfa) is used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis to lessen the need for red blood cell transfusions.
EPOGEN® should not be used in place of emergency treatment for anemia (red blood cell transfusions).
EPOGEN® has not been proven to improve quality of life, fatigue, or well-being.
Important Safety Information
Using EPOGEN® can lead to death or other serious side effects.
For all patients who take EPOGEN®, including patients with cancer or chronic kidney disease:
- Your healthcare provider should prescribe the smallest dose of EPOGEN® that is needed to reduce your chance of getting red blood cell transfusions.
- 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 hemoglobin level. If your hemoglobin level stays too high or goes up too quickly, this may also lead to these serious problems. 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
For 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 patient-healthcare provider acknowledgement form. When you sign this form, you are stating that your healthcare provider talked with you about the risks of taking EPOGEN®.
These risks include that your tumor may grow faster and you may die sooner if you choose to take EPOGEN®.
You should not take EPOGEN® if you:
- Have cancer and have not been counseled by your healthcare provider regarding the risks of EPOGEN® or if you have not signed the patient-healthcare provider acknowledgement form before you start EPOGEN® treatment.
- 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 protein medicines.
- Have had a serious allergic reaction to EPOGEN®.
Pregnant women, breastfeeding women, and babies should not receive EPOGEN® from multidose vials.
EPOGEN® may cause other serious side effects:
- High blood pressure. High blood pressure is a common side effect of EPOGEN® in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with 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 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, wheezing, dizziness and fainting due to 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.
Tell your healthcare provider if you are pregnant or breastfeeding, or are planning to become pregnant or breastfeed.
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 of 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 U.S. Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
