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Epoetin Alfa is used for:

Treating anemia in certain patients with kidney failure, HIV, or cancer. It may also be used to reduce the need for blood transfusions in some patients undergoing surgery. It may also be used for other conditions as determined by your doctor.

Epoetin Alfa is a glycoprotein. 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 , 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 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 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; inflammatory condition; or certain bone problems (osteitis fibrosa)

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.

• An extra patient leaflet is available with Epoetin Alfa . Talk to your pharmacist if you have questions about this information.
• 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 dilute Epoetin Alfa 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 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 , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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.
• Follow the diet and exercise program and dialysis instructions exactly as they were given to you by your health care provider.
• Rarely, Epoetin Alfa 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.
• Epoetin Alfa 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 Epoetin Alfa . Talk with your health care provider if you have questions about the possibility of becoming pregnant or the need for birth control.
• Lab tests, including kidney function, blood pressure, complete blood counts, or hemoglobin levels, will 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 has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
• 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.

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:

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

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; increased or rapid heartbeat; irritation at the injection site; numbness or tingling of the skin; numbness of an arm or leg; one-sided weakness; pale skin color; seizures; severe stomach pain; shortness of breath; sudden severe headache, dizziness, vomiting, or fainting; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Store Epoetin Alfa in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze or shake. Keep Epoetin Alfa , as well as syringes and needles, out of the reach of children and away from pets.

General information:

• 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.

This information is a summary only. It does not contain all information about Epoetin Alfa . 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.