epoetin alfa
Generic Name: epoetin alfa (e POE e tin AL fa)
Brand Names: Epogen, Procrit
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 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 discuss with my healthcare provider before using epoetin alfa?
Do not use this medication if you are allergic to epoetin alfa, darbepoetin alfa (Aranesp), or if you have:-
untreated or uncontrolled high blood pressure;
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an allergy to animal products; or
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an allergy to albumin.
Before using this medication, tell your doctor if you have:
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heart disease, congestive heart failure, or high blood pressure (hypertension);
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kidney disease (or if you are on dialysis);
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a history of stroke, heart attack, or blood clots;
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a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;
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cancer; or
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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 use 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?
Contact your doctor if you miss a dose of epoetin alfa.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.Overdose symptoms may include headache, dizziness, itching (especially after bathing), fullness in your upper stomach, redness of the face, shortness of breath, and vision problems.
What should I avoid while using 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.Epoetin alfa side effects
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;
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feeling short of breath, even with mild exertion;
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sudden numbness or weakness, especially on one side of the body;
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sudden headache, confusion, problems with vision, speech, or balance; or
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pain or swelling in one or both legs.
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feeling short of breath, even with mild exertion;
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swelling of your ankles or feet;
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increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness);
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feeling light-headed, fainting; or
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seizure (black-out or convulsions).
Less serious side effects may include:
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dizziness, mild headache;
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fever, sore throat, body aches, flu symptoms;
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nausea, vomiting, diarrhea, constipation; or
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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.
Epoetin alfa Dosing Information
Usual Adult Dose for Anemia Associated with Zidovudine:
For patients with serum erythropoietin levels less than or equal to 500 milliunits/mL who are receiving a dose of zidovudine less than or equal to 4200 mg/week the starting dose is: 100 units/kg subcutaneously or IV 3 times a week. The dose can be adjusted after 8 weeks in 50 to 100 units/kg increments 3 times weekly to maintain the hematocrit (Hct) within the suggested target range. If patients have not responded satisfactorily to a dose of 300 units/kg 3 times weekly, it is unlikely that they will respond to higher doses. Hct should be measured once a week.
Usual Adult Dose for Anemia Associated with Chemotherapy:
Based on the dosing recommendations for Epogen:
150 units/kg subcutaneously or IV 3 times a week. The dosage should be titrated to maintain a hematocrit in the target range of 30% to 33%, with a maximum of 36%. When appropriate, the dosage may be reduced to once or twice weekly. If patients have not responded satisfactorily to a dose of 300 units/kg 3 times weekly, it is unlikely that they will respond to higher doses. Hematocrit should be measured once a week.
Based on the dosing recommendations for Procrit:
Treatment of patients with grossly elevated serum erythropoietin levels (e.g., greater than 200 milliunits/mL) is not recommended. The hemoglobin should be monitored on a weekly basis in patients receiving Procrit until hemoglobin becomes stable. The dose of Procrit should be titrated to maintain the desired hemoglobin.
3 times per week dosing:
Initial dose: 150 units/kg subcutaneously 3 times a week
Maintenance dose: Reduce by 25% if hemoglobin approaches 12 g/dL or hemoglobin increases by more than 1 g/dL in any 2 week period.
Withhold dosing if the hemoglobin exceeds 13 g/dL, until the hemoglobin falls to 12 g/dL. Then restart the dose 25% below the previous dose.
Increase the dose to 300 units/kg 3 times per week if the response is not satisfactory (no reduction in transfusion requirements or rise in hemoglobin) after 8 weeks.
The suggested target hemoglobin range is 10 g/dL to 12 g/dL.
During therapy, hematologic parameters should be monitored regularly.
Weekly dosing:
Initial dose: 40,000 units subcutaneously weekly.
Maintenance dose: If after 4 weeks of therapy, the hemoglobin has not increased by 1 g/dL, in the absence of RBC transfusion, the dose of Procrit should be increased to 60,000 units weekly. If patients have not responded satisfactorily to a Procrit dose of 60,000 units weekly after 4 weeks, it is unlikely they will respond to higher doses.
Reduce by 25% if hemoglobin approaches 12 g/dL or hemoglobin increases by more than 1 g/dL in any 2 week period.
Withhold dosing if the hemoglobin exceeds 13 g/dL, until the hemoglobin falls to 12 g/dL. Then restart the dose 25% below the previous dose.
Usual Adult Dose for Anemia Associated with Chronic Renal Failure:
50 to 100 units/kg subcutaneously or IV 3 times weekly. The dose should be reduced as the hematocrit (Hct) approaches 36% or increases by more than 4 points in any 2 week period. The maintenance dose must be individualized to maintain the hematocrit within the target range. Hct should be evaluated twice weekly.
Usual Adult Dose for Anemia Prior to Surgery:
In patients with Hb greater than 10 to less than or equal to 13 g/dL scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogenic blood transfusions: 300 units/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and 4 days after surgery.
Alternate dosage schedule: 600 units/kg subcutaneously in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.
Usual Pediatric Dose for Anemia Associated with Zidovudine:
The safety and efficacy of epoetin alfa in children have not been established. However, the use of epoetin alfa may be appropriate in some situations.
Greater than or equal to 1 year to 18 years: 100 units/kg subcutaneously or IV 3 times weekly for 8 weeks. The dose can be adjusted after 8 weeks by 50 to 100 units/kg increments 3 times weekly to maintain the hematocrit within the suggested target range. If patients have not responded satisfactorily to a dose of 300 units/kg 3 times weekly, it is unlikely that they will respond to higher doses.
Usual Pediatric Dose for Anemia Associated with Chemotherapy:
The safety and efficacy of epoetin alfa in children have not been established. However, the use of epoetin alfa may be appropriate in some situations.
Greater than or equal to 1 year to 18 years: 150 units/kg subcutaneously or IV 3 times a week. The dosage should be titrated to maintain a hematocrit in the target range of 30% to 33%, with a maximum of 36%. When appropriate, the dosage may be reduced to once or twice weekly. If patients have not responded satisfactorily to a dose of 300 units/kg 3 times weekly, it is unlikely that they will respond to higher doses.
Usual Pediatric Dose for Anemia Associated with Chronic Renal Failure:
The safety and efficacy of epoetin alfa in children have not been established. However, the use of epoetin alfa may be appropriate in some situations.
Greater than or equal to 1 year to 18 years: 50 to 100 units/kg subcutaneously or IV 3 times weekly. The dose should be reduced as the hematocrit approaches 36% or increases by more than 4 points in any 2 week period. The maintenance dose must be individualized to maintain the hematocrit within the target range.
Usual Pediatric Dose for Anemia:
The safety and efficacy of epoetin alfa in children have not been established. However, the use of epoetin alfa may be appropriate in some situations.
Anemia of prematurity: 25 to 100 units/kg subcutaneously or IV 3 times weekly.
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.
Where can I get more information?
- Your pharmacist can provide more information about epoetin alfa.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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More epoetin alfa resources
epoetin alfa Drug Interactions
epoetin alfa Injection - Includes detailed dosage instructions.
Compare epoetin alfa with other medications for the treatment of:
Anemia Associated with Chronic Renal Failure, Anemia, Anemia, Chemotherapy Induced, Anemia, Drug Induced, Anemia Prior to Surgery
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