IMPORTANT SAFETY INFORMATION ABOUT EPOGEN®
EPOGEN® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease 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).
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:
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.