DARBEPOETIN ALFA (Systemic)

Some commonly used brand names are:

In the U.S.?

• Aranesp

In Canada?

• Aranesp

Category

• Antianemic

Description

Darbepoetinalfa ( dar-be-POE-e-tin AL-fa) stimulates thebone marrow to produce red blood cells. If the body does not produce enoughred blood cells, severe anemia can occur. This often occurs in people withchronic kidney failure whose kidneys are not working properly. Anemia canalso occur in people who have cancer and are receiving chemotherapy to treattheir cancer. Darbepoetin alfa is used to treat severe anemia in these people.Darbepoetin may be used for patients on dialysis and for patients not on dialysis.

Darbepoetin alfa is given by injection. It is available only with yourdoctor'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 willdo. This is a decision you and your doctor will make. For darbepoetin alfa,the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to darbepoetin alfa. Also tell your doctor and pharmacistif you are allergic to any other substances, such as foods, preservatives,or dyes. Also, tell your doctor and pharmacist if you are allergic to albumin.

Pregnancy?Darbepoetin alfa has not been studied in pregnantwomen. However, studies in animals have shown that darbepoetin alfa causessome other problems. Before taking this medicine, make sure your doctor knowsif you are pregnant or if you may become pregnant.

Breast-feeding? It is not known whether darbepoetin alfa passesinto human breast milk. Although most medicines pass into breast milk in smallamounts, many of them may be used safely while breast-feeding. Mothers whoare taking this medicine and who wish to breast-feed should discuss this withtheir doctor.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of darbepoetinalfa in children with use in other age groups.

Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.

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. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of darbepoetin. Make sure you tell your doctorif you have any other medical problems, especially:

• Aluminum poisoning or

• Bone marrow problems or
• Bone problems or
• Cancer or
• Folic acid deficiency or
• Infection or
• Inflammation or
• Vitamin B 12 deficiency?May cause a decrease or delay in responseto treatment with darbepoetin alfa.

• Blood or bleeding problems (history of) ?The safe use of darbepoetinhas not been determined for patients with a history of bleeding problems.

• Heart or blood vessel disease?May be worsened by taking darbepoetinalfa.

• High blood pressure?May become worse when taking darbepoetin.

• Pure red cell aplasia (rare bone marrow disorder resulting in lessred blood cells than normal)?Darbepoetin should not be used if you havethis condition because it could cause this medicine to not work.

Proper Use of This Medicine

Darbepoetinalfa is usually given by a health care professional. However, medicines givenby injection are sometimes used at home. If you will be using darbepoetinalfa 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. Do not reuse needles and syringes.

Put used needles and syringes in a puncture-resistantdisposable container, or dispose of them as directed by your healthcare professional.

Dosing?The dose of darbepoetin alfa will be differentfor different patients. Follow your doctor's orders orthe directions on the label.The following information includes onlythe average doses of darbepoetin alfa. If your doseis different, do not change it unless your doctor tells you to do so.

• For injection dosage form
  • For anemia from chronic kidney failure:
    • Adults?Dose is based on body weight and must be determinedby your doctor. Darbepoetin alfa is injected into a vein or under the skin.How often you take this medicine must be determined by your doctor. Your doctormay need to adjust the dose to determine the best dose for you.
    • Children?Use and dose must be determined by your doctor.
  • For anemia from cancer chemotherapy:
    • Adults?Dose is based on body weight and must be determinedby your doctor. Darbepoetin alfa is injected into a vein or under the skin.How often you take this medicine must be determined by your doctor. Your doctormay need to adjust the dose to determine the best dose for you.
    • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, contact your doctor forinstructions.

Storage?To store this medicine:

• Keep out of reach of children.
• Store in the refrigerator. However, keep the medicine from freezing.
• Store away from light.
• 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

Peoplewith severe anemia usually feel very tired and sick. When darbepoetin alfabegins to work, usually in about 6 weeks, most people start to feel better.Some people are able to be more active. However, darbepoetin alfa only correctsanemia. It has no effect on kidney disease, cancer or any other medical problemthat needs regular medical attention. Therefore, even if you are feeling muchbetter, it is very important that you do not miss anyappointments with your doctor or any dialysis treatments.

It is very important that your doctor check your bloodregularly while you are taking this medicine. Be sure and keep allof your appointments.

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 darbepoetinalfa treatment) may need to be on a special diet and/or to take medicine tokeep 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. 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.

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 tellsyou 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.

In addition to darbepoetin alfa, your body needs iron to make red bloodcells. Your doctor may direct you to take iron supplements. He or she mayalso direct you to take certain vitamins that help the iron work better. Be sure to follow your doctor's orders carefully, becausedarbepoetin alfa will not work properly if there is not enough iron in yourbody.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

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

More common

Abdominal or stomach pain; accumulationof pus; arm, back or jaw pain; blurred vision; breathing difficulties (irregular,noisy, trouble at rest); chest pain, discomfort,tightness, or heaviness; chills; confusion; cough producing mucus; decrease in amount of urine; diarrhea; dilated neck veins; dizziness or lightheadedness; fainting or lightheadedness; fast, slow, or irregular heartbeat; fatigue or tiredness(extreme or unusual); fever; headache; nausea; pain,tenderness, swelling or warmth over injection site; shortness of breath or troubled breathing; poundingin the ears; rapid breathing; rapid or pounding pulse; skin discoloration at injectionsite; sweating; swellingof ankles, face, fingers, feet, hands, or lower legs; unconsciousness; vomiting; weight gain; wheezing

Less common

Anxiety; convulsions; difficulty in speaking (slow speech or inability to speak); double vision; inability to move arms, legs, or facialmuscles (including numbness and tingling); troublethinking or walking

Rare

Fever and sore throat; hives; itching; pale skin; skin rash; unusual bleeding or bruising; unusual tiredness or weakness

Other side effectsmay occur that usually do not need medical attention. These side effects maygo away during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.

More common

Less common

Other side effects not listedabove may also occur in some patients. If you notice any other effects, checkwith your doctor.

Additional Information

Once a medicine has been approved for marketingfor a certain use, experience may show that it is also useful for other medicalproblems. Although this use is not included in product labeling, darbepoetinalfa is used in certain patients with the following medical condition:

• Anemia associated with cancer (in patients not receiving chemotherapy)

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