Epogen (epoetin alfa) is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.
Epogen is used to treat anemia (a lack of red blood cells in the body) in patients with chronic kidney disease. Epogen is also used in HIV patients who have anemia due to treatment with zidovudine and in cancer patients who have anemia due to chemotherapy.
Epogen may also be used for purposes not listed in this medication guide.
Important information
You should not use Epogen if you have untreated or uncontrolled high blood pressure, if you are allergic to epoetin alfa or darbepoetin alfa (Aranesp), or if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using either of these two drugs.
Before using Epogen, tell your doctor if you have epilepsy or a history of seizures. Epogen may cause seizures. Be careful if you drive or do anything that requires you to be awake and alert.
Epogen can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use epoetin alfa. Epogen may also shorten remission time or survival time in some people with certain types of cancer. Talk with your doctor about the risks and benefits of using Epogen.
Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain or heavy feeling, pain spreading to the arm or shoulder, shortness of breath, slurred speech, or problems with vision or balance.
To be sure Epogen is helping your condition, your blood may need to be tested often. Your blood pressure will also need to be checked. Visit your doctor regularly.
Contact your doctor if you feel weak, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to Epogen. Some women using Epogen have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Epogen is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
Before using Epogen
You should not use Epogen if you are allergic to epoetin alfa or darbepoetin alfa or (Aranesp), or if you have:
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untreated or uncontrolled high blood pressure; or
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if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using darbepoetin alfa or epoetin alfa.
To make sure you can safely use Epogen, tell your doctor if you have any of these other conditions:
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heart disease, congestive heart failure, or high blood pressure (hypertension);
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kidney disease (or if you are on dialysis);
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a history of stroke, heart attack, or blood clots;
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a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;
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cancer; or
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epilepsy or another seizure disorder.
Epogen is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
FDA pregnancy category C. It is not known whether Epogen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether epoetin alfa passes into breast milk or if it could harm a nursing baby. Do not use Epogen without telling your doctor if you are breast-feeding a baby. Some women using Epogen have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need to use birth control while you are using Epogen.
See also: Pregnancy and breastfeeding warnings (in more detail)
Epogen may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Epogen may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about your individual risk.
How should I use Epogen?
Use Epogen exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results.
Epogen is injected under the skin or into a vein through an IV. You may be shown how to use an IV at home.
Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
Epogen comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Do not shake the medication bottle or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.
Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure Epogen is helping your body produce red blood cells, your blood will need to be tested often. You may also need to check your blood pressure during treatment. Do not miss any scheduled appointments.
If you need surgery, tell the surgeon ahead of time that you are using Epogen.
Store Epogen in the refrigerator and protect from light. Do not freeze Epogen, and throw away the medication if it has become frozen.
What happens if I miss a dose?
Contact your doctor if you miss a dose of Epogen.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include headache, dizziness, itching (especially after bathing), fullness in your upper stomach, redness of the face, shortness of breath, and vision problems.
What should I avoid?
Epogen may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Epogen side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Epogen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.
Epogen can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Epogen.
Seek emergency medical help if you have symptoms of heart or circulation problems, such as:
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chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
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feeling short of breath, even with mild exertion;
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swelling, rapid weight gain;
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sudden numbness or weakness, especially on one side of the body;
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sudden severe headache, confusion, problems with vision, speech, or balance; or
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pain, swelling, warmth, or redness in one or both legs.
Stop using Epogen and call your doctor at once if you have any of these serious side effects:
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feeling light-headed, fainting;
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fever, chills, body aches, flu symptoms, sores in your mouth and throat;
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pale skin, feeling short of breath, rapid heart rate, trouble concentrating;
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easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
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seizure (black-out or convulsions);
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low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
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dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious Epogen side effects may include:
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cold symptoms such as stuffy nose, sneezing, cough, sore throat;
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joint pain, bone pain;
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muscle pain, muscle spasm;
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dizziness, depression, mild headache;
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weight loss;
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sleep problems (insomnia);
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nausea, vomiting, trouble swallowing; or
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pain or tenderness where you injected the medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Epogen?
There may be other drugs that can affect Epogen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
