Epogen
Generic Name: epoetin alfa (Injection route)
e-POE-e-tin AL-fa
- Warnings: Increased mortality, serious cardiovascular and thromboembolic events, and increased risk of tumor progression or recurrence
- Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs 11.3 g/dL; 14 vs 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
- Cancer:
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
- To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
- Discontinue following the completion of a chemotherapy course.
- Perisurgery: Epoetin alfa increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis .
Renal failure patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs 11.3 g/dL; 14 vs 10 g/dL) in two clinical studies. Therefore, in patients with renal failure, doses should be individualized to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL. In cancer patients with certain tumor types (ie, breast, non-small cell lung, head and neck, lymphoid, cervical), ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies. In patients with cancer, use the lowest ESA dose needed to avoid red blood cell transfusions, use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy, and discontinue following the completion of a chemotherapy course. Patients receiving myelosuppressive therapy should not be treated with ESAs when the anticipated outcome is cure. Deep venous thrombosis prophylaxis should be considered when epoetin alfa is used preoperatively .
Commonly used brand name(s):
In the U.S.
- Epogen
- Procrit
Available Dosage Forms:
- Solution
Therapeutic Class: Hematopoietic
Pharmacologic Class: Erythropoietin
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Uses For Epogen
Epoetin is a man-made version of human erythropoietin (EPO). EPO is produced naturally in the body, mostly by the kidneys. It stimulates the bone marrow to produce red blood cells. If the body does not produce enough EPO, severe anemia can occur. This often occurs in people whose kidneys are not working properly. Epoetin is used to treat severe anemia in these people.
Epoetin may also be used to prevent or treat anemia caused by other conditions, such as AIDS, chemotherapy, or surgery, as determined by your doctor.
This medicine is given by injection. It is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, epoetin is used in certain patients with the following medical conditions:
- Anemia in cancer.
- Anemia in cancer, not due to chemotherapy.
Before Using Epogen
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of epoetin in children over the age of one month.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of epoetin in the elderly.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Aluminum poisoning or
- Blood disorders (e.g., thalassemia, myelodysplastic syndrome) or
- Bone problems or
- Folic acid, iron, or vitamin B12 deficiencies or
- Infection, inflammation, or cancer or
- Porphyrin (red blood cell pigment) metabolism disorder or
- Sickle cell anemia—Epoetin may not work properly.
- Blood clots (history of) or other problems with the blood or
- Congestive heart failure or
- Heart attacks, history of or
- Heart bypass surgery or
- Heart or blood vessel disease or
- Seizures, history of or
- Stroke, history of or
- Thrombosis, at risk for—The chance of side effects may be increased.
- High blood pressure, uncontrolled
- Pure red cell aplasia (rare bone marrow disease)—Should not be used in patients with this condition.
Proper Use of epoetin alfa
This section provides information on the proper use of a number of products that contain epoetin alfa. It may not be specific to Epogen. Please read with care.
This medicine should come with a medication guide and patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Epoetin is usually given by a doctor after a dialysis treatment. However, medicines given by injection are sometimes used at home. If you will be using epoetin at home, your doctor will teach you how the injections are to be given. You will also have a chance to practice giving them. Be sure that you understand exactly how the medicine is to be prepared and injected.
This medicine may be given as a shot under your skin or into a vein. If your doctor tells you to inject it a certain way, follow your doctor's instructions.
If you are giving this medicine at home:
- Use a new needle and syringe each time you inject your medicine.
- Do not use more medicine or use it more often than your doctor tells you to.
- You will be shown the body areas where this shot can be given.
- Throw away used needles in a hard closed container that the needles cannot poke through. Keep this container away from children and pets.
Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
Do not shake the container of the medicine before you use it, and protect it from bright light.
Carefully follow your doctor's instructions about any special diet. You may need to eat foods that contain iron, folic acid, or vitamin B12 such as eggs, certain cereals, meats, and vegetables, or you may take an iron, folic acid, or vitamin B12 supplement while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form:
- For anemia from chronic kidney failure:
- Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 to 100 units per kilogram (kg) injected into a vein or under the skin three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
- Children 1 month to 12 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 units per kg injected into a vein or under the skin three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
- Infants younger than 1 month of age—Use and dose must be determined by your doctor.
- For anemia from cancer chemotherapy:
- Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The starting dose is 150 units per kilogram (kg) injected under the skin three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
- Children 1 month to 12 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 600 units per kg injected into a vein once a week. Your doctor may need to adjust the dose to determine the best dose for you.
- Infants younger than 1 month of age—Use and dose must be determined by your doctor.
- For anemia from HIV therapy:
- Adults —Dose is based on body weight and must be determined by your doctor. The starting dose is 100 units per kilogram (kg) injected into a vein or under the skin three times a week for 8 weeks. Your doctor may need to adjust the dose to determine the best dose for you.
- Children and teenagers 8months to 17 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 units per kg injected into a vein or under the skin two or three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
- Infants younger than 8months of age—Use and dose must be determined by your doctor.
- For anemia from surgery:
- Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The starting dose is 300 units per kilogram (kg) injected under the skin for 10 days before the surgery, on the day of the surgery, and for 4 days after surgery.
- Children 1 month to 12 years of age—Dose is based on body weight and must be determined by your doctor.
- Infants younger than 1 month of age—Use and dose must be determined by your doctor.
- For anemia from chronic kidney failure:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store in the refrigerator. Do not freeze.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Epogen
It is very important that your doctor check your blood regularly while you are taking this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away. .
This medicine contains benzyl alcohol which may cause serious reactions to newborn or premature infants. Discuss this with your doctor if you are concerned.
Epoetin sometimes causes convulsions (seizures), especially during the first 90 days of treatment. During this time, it is best to avoid driving, operating heavy machinery, or other activities that could cause a serious injury if a seizure occurs while you are performing them.
People with severe anemia usually feel very tired and sick. When epoetin begins to work, usually in about 6 weeks, most people start to feel better. Some people are able to be more active. However, epoetin only corrects anemia. It has no effect on kidney disease or any other medical problem that needs regular medical attention. Therefore, even if you are feeling much better, it is very important that you do not miss any appointments with your doctor or any dialysis treatments. .
This medicine may increase your risk of having serious heart and blood vessel problems, such as congestive heart failure, heart attack or stroke. Check with your doctor right away if you start having chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking. .
This medicine may increase your risk of having blood clots, especially in patients who use epoetin alfa before a major surgery. Check with your doctor right away if you have pain, redness, or swelling in your arms or legs while using this medicine. Your doctor may give you a blood thinner before surgery to help prevent blood clots.
When used in patients with certain types of cancer (e.g., breast, cervix, lymphoid, lung, head, or neck cancer), this medicine has shortened survival time and worsened the cancer in some patients. If you are concerned about this, talk with your doctor.
Epoetin is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.
Many people with kidney problems need to be on a special diet. Also, people with high blood pressure (which may be caused by kidney disease or by epoetin treatment) may need to be on a special diet and/or to take medicine to keep their blood pressure under control. After their anemia has been corrected, some people feel so much better that they want to eat more than before. To keep your kidney disease or your high blood pressure from getting worse, it is very important that you follow your special diet and take your medicines regularly, even if you are feeling better.
In addition to epoetin, your body needs iron to make red blood cells. Your doctor may direct you to take iron supplements. He or she may also direct you to take certain vitamins that help the iron work better. Be sure to follow your doctor's orders carefully, because epoetin will not work properly if there is not enough iron in your body.
Do not use this medicine if you have had an allergic reaction to albumin or products derived from mammalian cells.
Epogen Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common- Chest pain
- fever
- headache
- increased blood pressure
- shortness of breath
- swelling of the face, fingers, ankles, feet, or lower legs
- weight gain
- Anxiety
- blurred vision
- change in skin color
- change in vision
- convulsions (seizures)
- cough
- dizziness or lightheadedness
- double vision
- fainting
- fast heartbeat
- migraine headache
- nausea
- pain or discomfort in the arms, jaw, back, or neck
- pain, tenderness, or swelling of the foot or leg
- pains in the chest, groin, or legs, especially calves of the legs
- pale skin
- partial or complete loss of vision in the eye
- severe headaches of sudden onset
- skin rash or hives
- slurred speech
- sore throat
- sudden and severe inability to speak
- sudden loss of coordination
- sudden vision changes
- sweating
- temporary blindness
- tenderness, pain, swelling, warmth, or skin discoloration at the site of injection
- unusual bleeding or bruising
- unusual tiredness or weakness
- vision problems
- vomiting
- weakness in the arm or leg on one side of the body, sudden and severe
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common- Abdominal pain and swelling
- bone or joint pain, muscle aches, chills, shivering, or sweating
- constipation
- diarrhea
- dizziness
- general feeling of tiredness or weakness
- heartburn or belching, acid or sour stomach
- inability to sleep
- itching or stinging at the site of injection
- loss of strength or energy
- muscle pain or weakness
- nausea or vomiting
- skin pain
- stomach discomfort, upset, or pain
- weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
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More Epogen resources
Compare Epogen with other medications for the treatment of:
Anemia Associated with Chronic Renal Failure, Anemia, Anemia, Chemotherapy Induced, Anemia, Drug Induced, Anemia Prior to Surgery
