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 kidney failure, patients with HIV taking zidovudine, or cancer patients receiving chemotherapy for at least 2 months. It may also be used for other conditions as determined by your doctor.

Epogen is a glycoprotein. 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 , to human albumin, or to products that come from mammalian cells
  • you have uncontrolled high blood pressure or certain red blood cell problems (eg, aplasia)

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 seizures; a blood disorder (eg, porphyria, sickle cell anemia); bleeding or clotting problems; heart problems (eg, congestive heart failure, ischemic heart disease); high blood pressure; low blood iron, folic acid, or vitamin B12 levels; high blood aluminum levels; an infection; an inflammatory condition; or certain bone problems (eg, osteitis fibrosa)

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 dilute Epogen or use it with other solutions.
  • 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.
  • The risk of serious side effects may be greater if you use Epogen in high doses. Do NOT use more than the recommended dose without checking with your doctor.
  • Follow the diet and exercise program and dialysis instructions exactly as they were given to you by your health care provider.
  • Rarely, Epogen can lose its effectiveness after a period of time, and a very serious anemia can result. Tell your doctor immediately if symptoms of anemia recur, such as increased fatigue/weakness or pale skin color.
  • Epogen has albumin in it, which comes from human blood. There is an extremely rare risk of developing a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease. No cases of viral diseases or Creutzfeldt-Jakob disease from albumin have been identified.
  • Some patients who have stopped having menstrual periods may experience a return of menstrual periods following treatment with Epogen . Talk with your health care provider if you have questions about the possibility of becoming pregnant or the need for birth control.
  • 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, complete blood counts, and hemoglobin levels, will 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.

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:

Constipation; cough; diarrhea; headache; indigestion; joint or muscle aches; nausea; respiratory congestion; sleeplessness; stinging at the injection site; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain or tenderness; chest pain; confusion; fever, chills, or sore throat; increased fatigue/weakness; fast or irregular heartbeat; irritation at the injection site; numbness or pain of an arm or leg; numbness or tingling of the skin; one-sided weakness; pale skin color; seizures; severe stomach pain; shortness of breath; sudden severe headache, dizziness, vomiting, or fainting; sudden trouble walking or loss of balance; swelling of the fingers, ankles, or legs; unusual tiredness or weakness; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

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.

General information:

  • 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.

This information is a summary only. It does not contain all information about Epogen . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Epogen Prescribing Information (FDA)
  • Epogen Consumer Overview
  • Epogen Advanced Consumer (Micromedex) - Includes Dosage Information
  • Procrit Prescribing Information (FDA)
  • Procrit Consumer Overview