Epoetin alfa

Epoetin alfa

What is epoetin alfa?

Epoetin alfa is used to treat anemia caused by chemotherapy in adults and children aged 5 years and older.

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

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 surgical procedures.

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

Side effects of epoetin alfa

If necessary, get emergency medical helpSigns of an allergic reaction(hives, sweating, rapid pulse, wheezing, difficulty breathing, severe dizziness or fainting, swelling of the face or throat)or a severe skin reaction(Fever, sore throat, burning eyes, skin pain, red or purple rash with blistering and peeling).

Epoetin alfa can cause serious side effects, including heart attack or stroke.If necessary, seek emergency medical attention:

• Heart attack symptoms – chest pain or feeling of pressure, pain spreading to the jaw or shoulder, nausea, sweating;

• Signs of a blood clot - pain, swelling, warmth, redness, feeling cold or looking pale 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.

Epoetin alfa can cause serious side effects. Call your doctor immediately if you have:

• unusual tiredness;

• a seizure (convulsions);

• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath smell;

• low potassium - leg cramps, constipation, irregular heartbeat, fluttering in the chest, increased thirst or need to urinate, numbness or tingling, muscle weakness or feeling weak; or

• increased blood pressure – severe headache, blurred vision, throbbing in the neck or ears, anxiety, nosebleeds.

Common side effects of epoetin alfa may include:

• fever, chills, cough, shortness of breath;

• low potassium, low white blood cells;

• blockage of blood vessels;

• high blood sugar;

• joint pain, bone pain, muscle pain or cramps;

• itching or rash;

• Mouth pain, difficulty swallowing;

• nausea, vomiting;

• headache, dizziness;

• sleep disorders;

• depressed mood;

• weight loss; or

• Pain or redness at the injection site of the drug.

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 FDA at 1-800-FDA-1088.

Warnings

Epoetin alfa can cause serious side effects, including heart attack or stroke. Epoetin alfa may also accelerate tumor growth or shorten the time to remission or survival in some people.Talk to your doctor about the risks and benefits of using epoetin alfa.

You should not use this medicine if you have uncontrolled high blood pressure or if you have ever suffered from pure red cell aplasia (PRCA, a form of anemia) caused by the use of epoetin alfa or darbepoetin alfa.

Call your doctor immediately if you notice any signs of a blood clot:Sudden numbness or weakness, problems with vision or speech, chest pain, difficulty breathing, pain or feeling cold in an arm or leg.

Before you take this medicine

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 form of anemia) after using darbepoetin alfa or epoetin alfa; or

• You are using an epoetin alfa multi-dose vial and are pregnant or breast-feeding.

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

Epoetin alfa may speed up tumor growth or shorten the time to remission or survival in some people with certain types of cancer. Talk to 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 planning to become pregnant.

Do not breast-feed while using this medicine.and for at least 2 months after your last dose.

Do not use epoetin alfa from a multiple-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. However, there is still a small possibility that it could transmit disease. Ask your doctor about possible risks.

How should I use epoetin alfa?

Follow all instructions on your prescription label and read any medication guides or instructions for use. 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 doctor can teach you how to properly use the medication yourself.

Carefully read and follow all instructions for use that come with your medicine. Do not use epoetin alfa if you do not understand all instructions on how to use it properly. If you have any questions, contact your doctor or pharmacist.

Do not prepare your injection until you are ready to give it. Do not use if the medicine has changed color or contains particles. Call your pharmacist for a new medicine.

Do not shake epoetin alfa or it may be ruined.

Call your doctor if you feel weak, tired, or dizzy. These may be signs that your body is no longer responding to epoetin alfa.

Frequent medical tests may be needed to make sure this medicine is not causing harmful effects. Based on the results, your injections may be delayed.

You may be given other medications to prevent serious side effects. Take these medicines for as long as your doctor tells you.

If you need surgery, tell the surgeon in advance that you are using epoetin alfa. You may need to take medicine to prevent blood clots.

Epoetin alfa is just one part of a complete treatment program, which may include a special diet. Follow your doctor's instructions carefully.

Store in the refrigerator and protect from light.Do not freeze epoetin alfaand discard the medication if frozen.

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

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

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid when using epoetin alfa?

Avoid driving and dangerous activities until you know how epoetin alfa affects you. Your reactions may be affected.

What other drugs affect epoetin alfa?

Other medications can affect epoetin alfa, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

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More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.