epoetin alfa

What is the most important information I should know about epoetin alfa?

What is epoetin alfa?

Epoetin alfa is a man-made form of a protein that helps your body produce red blood cells. This protein 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.

Epoetin alfa is used to treat anemia caused by chemotherapy in adults and children at least 5 years old.

Epoetin alfa is also used to treat anemia caused by chronic kidney disease in adults and children at least 1 month old.

Epoetin alfa is also used to treat anemia in adults taking zidovudine to treat HIV (human immunodeficiency virus).

Epoetin alfa is also used to reduce the need for red blood cell transfusions in adults having certain types of surgery.

Epoetin alfa may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using epoetin alfa?

• you have untreated or uncontrolled high blood pressure;
• you have had pure red cell aplasia (PRCA, a type of anemia) after using darbepoetin alfa or epoetin alfa; or
• you use an epoetin alfa multi-dose vial and you are pregnant or breastfeeding.

Epoetin alfa may speed up tumor growth, or shorten remission or survival time in some people with certain types of cancer. Talk with your doctor about the risks and benefits of using epoetin alfa.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• a heart attack, stroke, or blood clot;
• a seizure disorder;
• phenylketonuria (PKU); or
• kidney disease (or if you are on dialysis).

Epoetin alfa is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

How should I use epoetin alfa?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Epoetin alfa is injected under the skin, or as an infusion into a vein. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use epoetin alfa if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Do not shake this medicine or you may ruin it.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your injections may be delayed based on the results.

If you need surgery, tell the surgeon ahead of time that you are using epoetin alfa. You may need to use a medicine to prevent blood clots.

Epoetin alfa is only part of a complete treatment program that may also include a special diet. Follow your doctor's instructions very closely.

Each single-use vial (bottle) of this medicine is for one use only. Throw it away after one use, even if there is still medicine left inside. Throw away any leftover medicine in a multi-dose vial 21 days after the first use.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using epoetin alfa?

What are the possible side effects of epoetin alfa?

• heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a blood clot --pain, swelling, warmth, redness, cold feeling, or pale appearance of an arm or leg; or
• signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

• unusual tiredness;
• a seizure (convulsions);
• high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Common side effects may include:

• fever, chills, cough, feeling short of breath;
• low potassium, low white blood cells;
• blood vessel blockage;
• high blood sugar;
• joint pain, bone pain, muscle pain or spasm;
• itching or rash;
• mouth pain, trouble swallowing;
• nausea, vomiting;
• headache, dizziness;
• trouble sleeping;
• depressed mood;
• weight loss; or
• pain or redness where the medicine was injected.

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.

What other drugs will affect epoetin alfa?

Other drugs may affect epoetin alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about epoetin alfa.