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EPOETIN (Systemic)

Some commonly used brand names are:

In the U.S.—

• Epogen
• Procrit

In Canada—

• Eprex

Other commonly used names are human erythropoietin, recombinant ; EPO ; and r-HuEPO .

Category

• Antianemic

Description

Epoetin (eh-POH-ee-tin) 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, cancer, or surgery, as determined by your doctor.

Epoetin is given by injection. It is available only with your doctor"s prescription and is available in the following dosage form:

• Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

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 epoetin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to epoetin or to human albumin. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Epoetin has not been reported to cause birth defects or other problems in humans. However, it did cause problems, including unwanted effects on the bones and spine, in some animal studies.

Breast-feeding—It is not known whether epoetin passes into the breast milk. However, it has not been reported to cause problems in nursing babies.

Children—This medicine has been tested in children and teenagers and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Older adults—Epoetin has been given to elderly people. However, there is no specific information about whether epoetin works the same way it does in younger adults or whether it causes different side effects or problems in older people.

Other 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. When you are taking epoetin, it is important that your health care professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of epoetin. Make sure you tell your doctor if you have any other medical problems, especially:

• Aluminum poisoning

• Blood clots (history of) or other problems with the blood or
• Folic acid, iron, or vitamin B₁₂ deficiencies
• Heart or blood vessel disease or
• Heart attacks, history of or
• Heart bypass surgery or
• High blood pressure or
• Thrombosis, at risk for—The chance of side effects may be increased

• Infection, inflammation, or cancer

• Bone problems or
• Porphyrin (red blood cell pigment) metabolism disorder—Symptoms include change in color of urine, increased sun sensitivity, abdominal pain, and nerve swelling
• Sickle cell anemia—Epoetin may not work properly

• Seizures (history of)—The chance of seizures may be increased

Proper Use of This Medicine

Epoetin is usually given by a health care professional after a dialysis treatment. However, medicines given by injection are sometimes used at home. If you will be using epoetin at home, your health care professional will teach you how the injections are to be given. You will also have a chance to practice giving them. Be certain that you understand exactly how the medicine is to be injected .

Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Dosing—The dose of epoetin 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 epoetin. If your dose is different, do not change it unless your doctor tells you to do so.

• For injection dosage form:
  • For severe anemia:
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. Epoetin is injected into a vein or under the skin. How often you take this medicine must be determined by your doctor. 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. Epoetin is injected into a vein or under the skin. How often you take this medicine must be determined by your doctor. Your doctor may need to adjust the dose to determine the best dose for you.
    • Children up to 1 month of age—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, use 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—To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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 .

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.

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.

Side Effects of This Medicine

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.

More common—for patients being treated for anemia due to chronic kidney failure who require dialysis (in addition to those listed above)

More common—for zidovudine-treated HIV-infected patients

More common—for cancer patients on chemotherapy

More common—for surgical patients

Other 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. Epoetin sometimes causes an influenza-like reaction, with symptoms such as muscle aches, bone pain, chills, shivering, and sweating, occurring about 1 or 2 hours after an injection. These symptoms usually go away within 12 hours. However, check with your doctor if this influenza-like reaction or any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

For patients receiving epoetin who do not have anemia caused by kidney disease:

• The information about the importance of keeping dialysis appointments and following a special diet for people with kidney problems does not apply to you. However, your doctor may have other special directions for you to follow. Be sure to follow these directions carefully, even if you feel much better after receiving epoetin for a while.

—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 caused by treatment of hepatitis C virus infection
• Anemia in critically ill patients who are in hospital intensive care units

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 10/21/2005

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