In the U.S.—

In Canada—

• Antianemic

Darbepoetin alfa ( dar-be-POE-e-tin AL-fa) stimulates the bone marrow to produce red blood cells. If the body does not produce enough red blood cells, severe anemia can occur. This often occurs in people with chronic kidney failure whose kidneys are not working properly. Anemia can also occur in people who have cancer and are receiving chemotherapy to treat their 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 your doctor's prescription and is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

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 darbepoetin alfa, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to darbepoetin alfa. Also tell your doctor and pharmacist if 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 pregnant women. However, studies in animals have shown that darbepoetin alfa causes some other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding— It is not known whether darbepoetin alfa passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of darbepoetin alfa in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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

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

• 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 response to treatment with darbepoetin alfa.
• Heart or blood vessel disease—May be worsened by taking darbepoetin alfa.
• Blood or bleeding problems (history of) —The safe use of darbepoetin has not been determined for patients with a history of bleeding problems.

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

Put used needles and syringes in a puncture-resistant disposable container, or dispose of them as directed by your health care professional.

Dosing—

The dose of darbepoetin alfa 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 darbepoetin alfa. If your dose is 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 determined by your doctor. The usual dose is 0.45 micrograms (mcg) per kilogram (kg) (0.2 mcg per pound) of body weight once a week, injected into a vein or under the skin. Your doctor may then gradually change the dose until the lowest effective dose is reached and some patients may be given this medication once every 2 weeks.
    • 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 determined by your doctor. The usual dose is 2.25 micrograms (mcg) per kilogram (kg) (0.2 mcg per pound) of body weight once a week, injected under the skin. Your doctor may then gradually change the dose until the lowest effective dose is reached.
    • Children—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, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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 sure that any discarded medicine is out of the reach of children.

People with severe anemia usually feel very tired and sick. When darbepoetin alfa begins 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 corrects anemia. It has no effect on kidney disease, cancer 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 darbepoetin alfa 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 darbepoetin alfa, 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 darbepoetin alfa will not work properly if there is not enough iron in your body.

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
  • Abdominal or stomach pain;  accumulation of 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;  pounding in the ears;  rapid breathing;  rapid or pounding pulse;  skin discoloration at injection site;  sweating;  swelling of 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 facial muscles (including numbness and tingling);  trouble thinking or walking 
  
  

• Rare
  • Hives;  itching;  skin rash 
  
  

  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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Constipation;  general feeling of discomfort or illness;  lack or loss of strength;  loss of appetite;  muscle aches, pains or stiffness;  runny nose;  pain in joints;  shivering;  sneezing;  sore throat;  trouble sleeping 
  
  

• Less Common
  • Confusion; ;  decreased urination;  dry mouth;  lightheadedness;  sunken eyes;  thirst;  wrinkled skin 
  
  

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

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 this use is not included in product labeling, darbepoetin alfa 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 relating to proper use, precautions, or side effects for this use.