Generic Name: epoetin alfa (e-POE-e-tin AL-fa)
Brand Name: Examples include Epogen and Procrit
Clinical studies have shown Epogen to increase the risk of serious side effects (eg, blood clots, stroke, heart attack, heart failure) and death in some cases. It has also been shown to shorten the overall survival and/or increase the risk of tumor growth or recurrence in patients with certain types of cancer. Talk with your doctor about the risks and benefits of using Epogen. Do not use more than the recommended dose without checking with your doctor.
Epogen is used for:
Treating anemia in certain patients with chronic kidney disease, anemia caused by chemotherapy in certain cancer patients, or anemia caused by taking zidovudine in certain HIV patients. It is also used to reduce the need for blood transfusions in certain patients who are at high risk of blood loss caused by certain types of surgeries. It may also be used for other conditions as determined by your doctor.
Epogen is a synthetic erythropoietin analog. It works by stimulating the bone marrow to produce more red blood cells.
Do NOT use Epogen if:
- you are allergic to any ingredient in Epogen, including if you have had a severe allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness) to Epogen
- you have uncontrolled high blood pressure
- you have developed a certain type of anemia called pure red cell aplasia (PRCA) after receiving a previous dose of Epogen or other erythropoietin protein medicines (eg, darbepoetin)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Epogen:
Some medical conditions may interact with Epogen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of cancer, seizures, kidney problems (eg, decreased kidney function, kidney failure), blood problems (eg, sickle cell anemia, porphyria, hemolytic anemia, thalassemia), bleeding or clotting problems, stroke, a heart attack or other heart problems (eg, congestive heart failure, ischemic heart disease), diabetes, or high blood pressure
- if you have blood in your stools; an inflection or recent injury; certain bone problems (eg, osteofibrosis cystica); an inflammatory condition (eg, bowel disease, rheumatoid arthritis); low blood iron, folic acid, or vitamin B12 levels; or high blood aluminum levels
- if you are on hemodialysis, have recently had surgery, or are scheduled to have surgery
Some MEDICINES MAY INTERACT with Epogen. However, no specific interactions with Epogen are known at this time. Tell your health care provider if you are taking any other medicines.
Ask your health care provider if Epogen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Epogen:
Use Epogen as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
- Epogen comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Epogen refilled.
- Epogen is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Epogen at home, a health care provider will teach you how to use it. Be sure you understand how to use Epogen. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- When drawing up a dose into a syringe, be sure to follow the procedure demonstrated to you to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers.
- Always carefully check that you have drawn up the correct dose before administration.
- Do not shake Epogen. Do not use Epogen if it has been shaken.
- Do not use Epogen if it has been frozen.
- Do not dilute Epogen. Do not mix it with other solutions unless your doctor directs you otherwise.
- If you are using a single-dose vial, throw away any medicine left in the vial after you have used your dose. Ask your doctor, pharmacist, or other health care provider if you have questions about whether you are using a single-dose vial.
- Do not use Epogen if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- Continue to use Epogen even if you feel well. Do not miss any doses.
- If you miss a dose of Epogen, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Epogen.
Important safety information:
- Epogen may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Epogen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- It may take several weeks for Epogen to work. Do not stop taking Epogen without checking with your doctor.
- Do NOT use more than the recommended dose without checking with your doctor.
- It is important to keep your blood pressure under control while you use Epogen. Do not stop taking any of your blood pressure medicines without checking with your doctor. Closely follow your doctor's instructions for diet and blood pressure monitoring.
- Tell your doctor immediately if symptoms of anemia persist or recur, such as increased fatigue/weakness or pale skin color.
- Epogen contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used Epogen.
- Tell your doctor or dentist that you take Epogen before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including kidney function, blood pressure, iron studies, and hemoglobin levels may be performed while you use Epogen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Epogen may have benzyl alcohol in it. Do not use medicine with benzyl alcohol in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects. Check with your doctor or pharmacist to see if your product has benzyl alcohol in it.
- Epogen should be used with extreme caution in CHILDREN younger than 1 month old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Epogen while you are pregnant. It is not known if Epogen is found in breast milk. If you are or will be breast-feeding while you use Epogen, check with your doctor. Discuss any possible risks to your baby. Epogen may contain the preservative benzyl alcohol. If you are pregnant or are breast-feeding, use a formulation without this preservative. Discuss any questions or concerns with your doctor or pharmacist.
Possible side effects of Epogen:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Cough; headache; joint or bone pain; mild muscle pain; mild pain or redness at the injection site; muscle spasms; nausea; trouble sleeping; vomiting; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf or leg pain, redness, tenderness, or swelling; chest, jaw, or left arm pain; confusion; coughing up blood; depression; fainting; fast or irregular heartbeat; fever, chills, or sore throat; muscle pain, weakness, or cramping; new or worsening pale skin color, or tiredness or weakness; numbness of an arm or leg; one-sided weakness; seizures; severe or persistent pain or irritation at the injection site; shortness of breath; sudden, severe headache, dizziness, or vomiting; sudden trouble walking, or loss of balance or coordination; swelling of the fingers, ankles, or legs; swelling or soreness of the mouth or tongue; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing; rapid breathing; fruit-like breath odor); trouble swallowing; vision or speech problems; weight gain.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe or persistent headache or dizziness.Proper storage of Epogen:
Epogen is usually handled and stored by a health care provider. If you are using Epogen at home, store Epogen as directed by your pharmacist or health care provider. Keep Epogen, as well as syringes and needles, out of the reach of children and away from pets.
- If you have any questions about Epogen, please talk with your doctor, pharmacist, or other health care provider.
- Epogen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Epogen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Epogen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Epogen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Epogen.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.