What is epoetin alfa?
Epoetin alfa is a man-made form of a protein that helps your body produce red blood cells.
The amount of this protein in your body 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 (a lack of red blood cells in the body).
Epoetin alfa may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking epoetin alfa?
Do not use this medication if you are allergic to epoetin alfa, darbepoetin alfa (Aranesp), or
if you have:
Before using this medication, tell your doctor if you have:
-
heart disease, congestive heart failure, or high blood pressure
(hypertension);
-
kidney disease (or if you are on dialysis);
-
a history of stroke, heart attack, or blood clots;
-
a blood cell or clotting disorder, such as sickle cell anemia
or hemophilia;
-
cancer; or
-
epilepsy or another seizure disorder.
If you have any of the conditions listed above, you may need a dose
adjustment or special tests to safely use epoetin alfa.
Epoetin alfa is made from human plasma (part of the blood) and may contain viruses and other
infectious agents that can cause disease. Although donated human plasma is screened, tested, and
treated to reduce the risk of it containing anything that could cause disease, there is still a small
possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this
medication.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your
doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether epoetin alfa passes into breast milk or if it could harm a nursing
baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Some women using epoetin alfa have started having menstrual periods, even after not
having a period for a long time due to a medical condition. You may be able to get pregnant if your
periods restart. Talk with your doctor about the need to use birth control while you are using epoetin
alfa.
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.
How should I take epoetin alfa?
Use this medication exactly as it was prescribed for you. Do not use the medication in larger
amounts, or use it for longer than recommended by your doctor. Follow the instructions on your
prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from this
medication.
Epoetin alfa is given as an injection under the skin or into a vein. Your doctor, nurse, or
pharmacist will give you specific instructions on how and where to inject this medicine. With your
medication you will receive patient instructions.
Do not self-inject this medicine if you do not fully understand how to give the injection and
properly dispose of needles, IV tubing, and other items used in giving the medicine.
Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw
your epoetin alfa dose into a syringe until you are ready to give yourself an injection. Do not use the
medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.
Use each disposable needle only one time. Throw away used needles in a puncture-proof
container (ask your pharmacist where you can get one and how to dispose of it). Keep this container
out of the reach of children and pets.
Store epoetin alfa in the refrigerator and do not allow it to freeze.
To be sure this medication is helping your body produce red blood cells, your blood will need
to be tested on a regular basis. You may also need to check your blood pressure during treatment. Do
not miss any scheduled appointments.
What happens if I miss a dose of epoetin alfa?
Contact your doctor if you miss a dose of epoetin alfa.
Where can I get more information about epoetin alfa?
Your pharmacist has information about epoetin alfa written for health professionals that you may read.
What are the possible side effects of epoetin alfa?
Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale.
These may be signs that your body has stopped responding to this medication.
Epoetin alfa can increase your risk of life-threatening heart or circulation problems, including
heart attack or stroke. This risk will increase the longer you use epoetin alfa. Seek emergency medical
help if you have symptoms of heart or circulation problems, such as:
-
chest pain or heavy feeling, pain spreading to the arm or shoulder,
nausea, sweating, general ill feeling;
-
feeling short of breath, even with mild exertion;
-
sudden numbness or weakness, especially on one side of the
body;
-
sudden headache, confusion, problems with vision, speech,
or balance; or
-
pain or swelling in one or both legs.
Get emergency medical help if you have any of these
signs of
an allergic reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using epoetin alfa and call your doctor at once if you have any of these serious side
effects:
-
feeling short of breath, even with mild exertion;
-
swelling of your ankles or feet;
-
increased blood pressure (severe headache, blurred vision,
trouble concentrating, chest pain, numbness);
-
feeling light-headed, fainting; or
-
seizure (black-out or convulsions).
Less serious side effects may include:
-
dizziness, mild headache;
-
fever, sore throat, body aches, flu symptoms;
-
nausea, vomiting, diarrhea, constipation; or
-
pain or tenderness where you injected the medication.
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. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about epoetin alfa?
This medicine can increase your risk of life-threatening heart or circulation problems,
including heart attack or stroke. This risk will increase the longer you use epoetin alfa. Seek emergency
medical help if you have symptoms of heart or circulation problems, such as chest pain or heavy feeling,
pain spreading to the arm or shoulder, shortness of breath, slurred speech, or problems with vision or
balance.
Before using epoetin alfa, tell your doctor if you have epilepsy or a history of seizures. Epoetin
alfa may cause seizures. Be careful if you drive or do anything that requires you to be awake and alert.
Do not self-inject this medicine if you do not fully understand how to give the injection and
properly dispose of all items used in giving the medicine.
Contact your doctor if you feel weak, light-headed, or short of breath, or if your skin looks
pale. These may be signs that your body has stopped responding to epoetin alfa.
Some women using epoetin alfa have started having menstrual periods, even after not
having a period for a long time due to a medical condition. You may be able to get pregnant if your
periods restart. Talk with your doctor about the need for birth control.
Epoetin alfa is made from human plasma (part of the blood) and may contain viruses and other
infectious agents that can cause disease. Although donated human plasma is screened, tested, and
treated to reduce the risk of it containing anything that could cause disease, there is still a small
possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this
medication.
What should I avoid while taking epoetin alfa?
Epoetin alfa can cause side effects that may impair your thinking or reactions. Be careful if
you drive or do anything that requires you to be awake and alert.
What other drugs will affect epoetin alfa?
There may be other drugs that can affect epoetin alfa. Tell your doctor about all the
prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal
products, and drugs prescribed by other doctors. Do not start using a new medication without telling
your doctor.
What happens if I have an overdose of epoetin alfa?
