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 or chronic kidney disease, or anemia caused by taking zidovudine to treat HIV (human immunodeficiency virus).

Epoetin alfa is also used to reduce the need for red blood cell transfusions in people 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 breast-feeding.

Epoetin alfa may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Epoetin alfa may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about your individual risk.

To make sure epoetin alfa is safe for you, tell your doctor if you have:

• heart disease, high blood pressure;
• kidney disease (or if you are on dialysis);
• a seizure disorder; or
• a history of stroke, heart attack, or blood clots.

Epoetin alfa is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use epoetin alfa?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Epoetin alfa is injected under the skin, or into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

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

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 of these tests.

You may need to take blood pressure medication while you are using epoetin alfa. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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.

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

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container 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 stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot --pain, swelling, warmth, redness, cold feeling, or pale appearance of an arm or leg; or
• dangerously high blood pressure --severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats.

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

Common side effects may include:

• increased blood pressure;
• joint pain, bone pain, muscle pain;
• itching or rash;
• fever, cough;
• nausea, vomiting;
• headache;
• mouth pain; 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 interact with epoetin alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about epoetin alfa.