Generic Name: epoetin alfa (e-POE-e-tin AL-fa)
Brand Name: Examples include Epogen and Procrit
Clinical studies have shown epoetin alfa 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 epoetin alfa. Do not use more than the recommended dose without checking with your doctor.
Epoetin alfa 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.
Epoetin alfa is a synthetic erythropoietin analog. It works by stimulating the bone marrow to produce more red blood cells.
Do NOT use epoetin alfa if:
- you are allergic to any ingredient in epoetin alfa, 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 epoetin alfa
- 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 epoetin alfa 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 epoetin alfa:
Some medical conditions may interact with epoetin alfa. 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 epoetin alfa. However, no specific interactions with epoetin alfa are known at this time. Tell your health care provider if you are taking any other medicines.
Ask your health care provider if epoetin alfa 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 epoetin alfa:
Use epoetin alfa 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.
- Epoetin alfa comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get epoetin alfa refilled.
- Epoetin alfa is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using epoetin alfa at home, a health care provider will teach you how to use it. Be sure you understand how to use epoetin alfa. 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 epoetin alfa. Do not use epoetin alfa if it has been shaken.
- Do not use epoetin alfa if it has been frozen.
- Do not dilute epoetin alfa. 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 epoetin alfa 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 epoetin alfa even if you feel well. Do not miss any doses.
- If you miss a dose of epoetin alfa, contact your doctor right away.
Ask your health care provider any questions you may have about how to use epoetin alfa.
Important safety information:
- Epoetin alfa may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use epoetin alfa 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 epoetin alfa to work. Do not stop taking epoetin alfa 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 epoetin alfa. 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.
- Epoetin alfa 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 epoetin alfa.
- Tell your doctor or dentist that you take epoetin alfa 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 epoetin alfa. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Epoetin alfa 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.
- Epoetin alfa 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 epoetin alfa while you are pregnant. It is not known if epoetin alfa is found in breast milk. If you are or will be breast-feeding while you use epoetin alfa, check with your doctor. Discuss any possible risks to your baby. Epoetin alfa 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 epoetin alfa:
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 epoetin alfa:
Epoetin alfa is usually handled and stored by a health care provider. If you are using epoetin alfa at home, store epoetin alfa as directed by your pharmacist or health care provider. Keep epoetin alfa, as well as syringes and needles, out of the reach of children and away from pets.
- If you have any questions about epoetin alfa, please talk with your doctor, pharmacist, or other health care provider.
- Epoetin alfa 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 epoetin alfa 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 epoetin alfa. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to epoetin alfa. 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 epoetin alfa.
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.