Pronunciation:

dar-be-POE-e-tin AL-fa

Brand Names:

• Aranesp

Dosage Forms:

• Solution

Warnings:

• 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 .

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 .

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Erythropoietic

Uses of This Medicine:

Darbepoetin alfa causes 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. Darbepoetin may be used for patients on kidney dialysis or for those not on dialysis. Anemia can also occur in people who are receiving chemotherapy to treat cancer. Darbepoetin alfa is used to treat severe anemia in these patients .

Darbepoetin alfa is available only with your doctor's prescription .

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 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.

Children—

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of darbepoetin alfa in children with chronic kidney failure who are over 1 year of age. Safety and efficacy have not been established in children with chronic kidney failure who are less than 1 year of age .

No information is available on the relationship of age to the effects of darbepoetin alfa in children with cancer. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of darbepoetin alfa 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.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Thalidomide

Other interactions—

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, severe or
• Bleeding, severe or
• Bone fibrosis (osteofibrosis cystica) or
• Bone marrow fibrosis or
• Folic acid deficiency or
• Infections or
• Iron deficiency or
• Vitamin B-12 deficiency—May cause a delay in response to treatment .

• Blood problems (e.g., hemolytic anemia, sickle cell anemia, thalassemia, porphyria) or
• High blood pressure, uncontrolled or
• Pure red cell aplasia (rare bone marrow disease)—Should not use in patients with these conditions .

• Blood vessel disease or
• Heart disease—May become worse with this medicine .

Proper Use of This Medicine:

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. Be sure you understand exactly how the medicine is to be injected .

Do not reuse needles and syringes. Put used needles and syringes in a hard, closed container that the needles cannot poke through (puncture-resistant), or dispose of them as directed by your health care professional. Keep this container away from children and pets .

Do not shake the container of medicine before you use it, and protect it from bright light .

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—Dose is based on body weight and must be determined by 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 doctor may 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 determined by 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 doctor may need to adjust the dose to determine the best dose for you.
    • Children—Use and dose must be determined by your doctor .

Missed dose—

Call your doctor or pharmacist for instructions.

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 This Medicine:

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. But darbepoetin alfa only corrects anemia. It has no effect on kidney disease, cancer, or any other medical problem that needs regular medical attention. 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 .

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 .

Darbepoetin alfa may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection .

This medicine may increase your risk of having blood clots. This is more likely in patients who use high doses of this medicine, or who use this medicine before major surgery. If you have shortness of breath, or pain, redness, or swelling in your arms or legs while using this medicine, call your doctor right away. If you are getting kidney dialysis treatments, tell your doctor right away if you notice blood clots at your injection site. Your doctor may give you a blood thinner before surgery to help prevent blood clots .

This medicine may also increase your risk of having serious heart and blood vessel problems such as heart attack, congestive heart failure, or stroke. Check with your doctor right away if you start having chest pain, trouble breathing, sudden or severe headache, or problems with vision, speech, or walking .

Also tell your doctor if you start having dizziness, fainting spells, or severe tiredness while using this medicine. These could be symptoms of a serious problem .

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 .

Darbepoetin alfa sometimes causes convulsions (seizures), especially during the first few months 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.

One form of darbepoetin alfa 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 .

The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine .

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 and vitamins to make red blood cells. Your doctor may direct you to take iron or vitamin supplements. Be sure to follow your doctor's orders carefully. Darbepoetin alfa will not work well if you do not have enough iron or vitamins in your body .

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.

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 problems (irregular, noisy, trouble when resting)

chest pain, discomfort, tightness, or heaviness

chills

confusion

cough producing mucus

decrease in amount of urine

diarrhea

dilated neck veins

dizziness or lightheadedness

dry mouth

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

pounding in the ears

rapid breathing

rapid or pounding pulse

shortness of breath

skin discoloration at injection site

sunken eyes

sweating

swelling of ankles, face, fingers, feet, hands, or lower legs

thirst

trouble with breathing

unconsciousness

vomiting

weight gain

wheezing

wrinkled skin

Less common

Anxiety

convulsions

difficulty with speaking (slow speech or unable to speak)

double vision

trouble with thinking

trouble with walking

unable to move arms, legs, or face muscles (including numbness and tingling)

Rare

Fever and sore throat

hives

itching

pale skin

skin rash

unusual tiredness or weakness

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

Constipation

general feeling of discomfort or illness

lack or loss of strength

loss of appetite

muscle aches, pains, or stiffness

pain in joints

runny nose

shivering

sneezing

trouble with sleeping

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