Epoetin alfa

Epoetin alfa is a man-made version of a protein that helps your body make red blood cells. This protein may be lower when you have kidney failure or take certain medications. When fewer red blood cells are made, it can lead to a condition called anemia.

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

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

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

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

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

epoetin alfa can lead to serious side effects, such as heart attack or stroke. epoetin alfa may also increase tumor growth or reduce remission or survival time in some individuals. Discuss the risks and benefits of using epoetin alfa with your doctor.

You should not use this medicine if you have uncontrolled high blood pressure, or if you have ever experienced pure red cell aplasia (PRCA, a type of anemia) due to using epoetin alfa or darbepoetin alfa.

Contact your doctor immediately if you notice signs of a blood clot: sudden numbness or weakness, difficulties with vision or speech, chest pain, trouble breathing, or pain or cold feeling in an arm or leg.

You should not use this medication if you are allergic to epoetin alfa or darbepoetin alfa, or if:

• 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.

Do not use epoetin alfa from a multi-dose vial when giving medicine to a baby. The multi-dose vial contains an ingredient that can cause serious side effects or death in very young infants or premature babies.

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).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

Do not use epoetin alfa from a multi-dose vial if you are pregnant or breastfeeding.

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.

Get emergency medical help if you notice signs of an allergic reaction (hives, sweating, fast heartbeat, wheezing, difficulty breathing, severe dizziness or fainting, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Epoetin alfa can cause serious side effects, including heart attack or stroke. Seek emergency medical help if you experience:

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

Epoetin alfa may cause serious side effects. Call your doctor right away if you have:

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

Common side effects of epoetin alfa 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 can report side effects to the FDA at 1-800-FDA-1088.

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 epoetin alfa or you may ruin it.

Call your doctor if you feel weak, tired, or light-headed. These may be signs that your body has stopped responding to epoetin alfa.

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.

You may be given other medications to help prevent serious side effects. Keep using these medicines for as long as your doctor has prescribed.

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.

Store in the refrigerator and protect from light. Do not freeze epoetin alfa, and throw away the medication if it has become frozen.

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.

Call your doctor for guidance if you miss a dose of epoetin alfa.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or doing anything dangerous until you understand how epoetin alfa will affect you. Your reactions may be impaired.

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.

Biosimilar and interchangeable products are biological products that are very similar to and have no important differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for epoetin alfa.

Epogen/Procrit (epoetin alfa) - Amgen Inc.

View Epogen/Procrit information in detail.

Procrit (epoetin alfa) - Amgen Inc.

View Procrit information in detail.

Epogen/Procrit, Procrit biosimilar products

Biosimilar products can only be given instead of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state.

Retacrit (epoetin alfa-epbx) - Hospira Inc., a Pfizer Company

View Retacrit information in detail.

• What biosimilars have been approved in the United States?