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 stimulatesthe bone marrow to produce red blood cells. If the body does not produce enoughEPO, severe anemia can occur. This often occurs in people whose kidneys arenot 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'sprescription 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 willdo. This is a decision you and your doctor will make. For epoetin, the followingshould be considered:

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

Pregnancy?Epoetin has not been reported to cause birth defectsor other problems in humans. However, it did cause problems, including unwantedeffects on the bones and spine, in some animal studies.

Breast-feeding?It is not known whether epoetin passes into thebreast milk. However, it has not been reported to cause problems in nursingbabies.

Children?This medicine has been tested in children and teenagersand, in effective doses, has not been shown to cause different side effectsor 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 wayit does in younger adults or whether it causes different side effects or problemsin older people.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingepoetin, it is important that your health care professional know if you aretaking any other prescription or nonprescription (over-the-counter [OTC])medicine.

Other medical problems?The presence of other medicalproblems may affect the use of epoetin. Make sure you tell your doctor ifyou 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?Symptomsinclude 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 isusually given by a health care professional after a dialysis treatment. However,medicines given by injection are sometimes used at home. If you will be usingepoetin at home, your health care professional will teach you how the injectionsare to be given. You will also have a chance to practice giving them. Be certain that you understand exactly how the medicine is tobe injected.

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

Dosing?The dose of epoetin will be different for differentpatients. Follow your doctor's orders or the directionson the label. The following information includes only the average dosesof epoetin. If your dose is different, do not changeit 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 mustbe determined by your doctor. Epoetin is injected into a vein or under theskin. 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 weightand must be determined by your doctor. Epoetin is injected into a vein orunder the skin. How often you take this medicine must be determined by yourdoctor. Your doctor may need to adjust the dose to determine the best dosefor you.
    • Children up to 1 month of age?Use and dose must be determinedby your doctor.

Missed dose?If you miss a dose of this medicine, use it assoon as possible. However, if it is almost time for your next dose, skip themissed 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 surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Epoetinsometimes causes convulsions (seizures), especially during the first 90 daysof treatment. During this time, it is best to avoid driving, operating heavymachinery, or other activities that could cause a serious injury if a seizureoccurs while you are performing them.

People with severe anemia usually feel very tired and sick. When epoetinbegins 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 needsregular medical attention. Therefore, even if you are feeling much better, it is very important that you do not miss any appointmentswith your doctor or any dialysis treatments.

Many people with kidney problems need to be on a special diet. Also, peoplewith high blood pressure (which may be caused by kidney disease or by epoetintreatment) may need to be on a special diet and/or to take medicine to keeptheir blood pressure under control. After their anemia has been corrected,some people feel so much better that they want to eat more than before. Tokeep your kidney disease or your high blood pressure from getting worse, it is very important that you follow your special diet and takeyour medicines regularly, even if you are feeling better.

In addition to epoetin, your body needs iron to make red blood cells. Yourdoctor may direct you to take iron supplements. He or she may also directyou to take certain vitamins that help the iron work better. Be sure to follow your doctor's orders carefully, because epoetin willnot 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 yourdoctor 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 needlescannot 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 mayneed medical attention.

Check with your doctorimmediately if any of the following side effects occur:

More common-in any treatment group

Chest pain; shortness of breath

Less common-in any treatment group

Anxiety ; blurred vision ; convulsions (seizures); cough ; dizziness or lightheadedness; fainting ; fast heartbeat ; nausea ; pain or discomfort in arms, jaw, back or neck; pains in chest, groin, or legs, especially calves of legs ; severe headaches of sudden onset; suddenloss of coordination ; sudden and severe inabilityto speak ; slurred speech ; sudden vision changes; sweating ; temporary blindness; vomiting; weakness in arm and/or leg on one side of the body, sudden and severe

Also,check with your doctor as soon as possible if any of the following side effectsoccur:

More common?for patients being treated for anemia due to chronickidney failure

Fever; headache; increased blood pressure; swelling of face, fingers,ankles, feet, or lower legs; vision problems; weight gain

Rare?for patients being treated for anemia due to chronic kidneyfailure

Changes in skin color; changes in vision; double vision; migraineheadache; pain, tenderness, swelling of foot or leg; pale skin; partial orcomplete loss of vision in eye; skin rash or hives; sore throat; tenderness,pain, swelling, warmth, skin discoloration, and prominent superficial veinsover affected area; unusual bleeding or bruising; unusual tiredness or weakness

More common?for patients being treated for anemia due to chronickidney 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 themedicine. Epoetin sometimes causes an influenza-like reaction, with symptomssuch as muscle aches, bone pain, chills, shivering, and sweating, occurringabout 1 or 2 hours after an injection. These symptoms usually go away within12 hours. However, check with your doctor if this influenza-like reactionor any of the following side effects continue or are bothersome:

More common?in all treatment groups

Diarrhea; dizziness; nausea or vomiting

More common ?for patients being treated for anemia due to chronickidney failure (in addition to those listed above)

Bone or joint pain, muscle aches, chills, shivering, sweating; general feeling of tiredness or weakness; itching or stinging at site of injection; loss of strength or energy; muscle pain or weakness

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

Abdominal pain and swelling; constipation; cough; fever; sore throat; weight loss

More common ?for zidovudine-treated HIV-infected patients

Congestion in the lungs; cough; general feeling of tiredness or weakness; itching or stinging at site of injection; loss ofstrength or energy; muscle pain or weakness

More common?for cancer patients on chemotherapy

General feeling of tiredness or weakness; loss of strength or energy; muscle pain or weakness; tingling, burning or prickly sensation

More common?for surgical patients

Anxiety; constipation; heartburn or belching, acid or sour stomach; inability to sleep; itching or stinging at site ofinjection; skin pain; stomachdiscomfort, upset or pain

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

Additional Information

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

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

?Once a medicine has been approved for marketing for a certainuse, experience may show that it is also useful for other medical problems.Although these uses are not included in product labeling, epoetin is usedin 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 careunits

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