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Darbepoetin Alfa Injection

(dar be poe' e tin)

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IMPORTANT WARNING:   Return to top

All patients:

Darbepoetin alfa increases the risk of blood clots forming in or moving to the legs, lungs, or brain. Call your doctor immediately if you experience any of the following symptoms: pain, tenderness, redness, warmth, and/or swelling in the legs; shortness of breath; cough that won't go away or that brings up blood; chest pain; sudden trouble seeing in one or both eyes; sudden trouble speaking or understanding speech; sudden confusion; sudden weakness or numbness of an arm or leg (especially on one side of the body), or of the face; sudden trouble walking or loss of balance or coordination; sudden severe headache; or seizure.

Using darbepoetin alfa increases the risk that you will develop a blood clot during or after surgery. Before you have surgery, tell your doctor that you are using darbepoetin alfa. Your doctor may prescribe an anticoagulant ('blood thinner') to help prevent blood clots from forming during or after surgery.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to darbepoetin alfa. Your doctor may decrease your dose if the tests show that you are at high risk of experiencing serious side effects of darbepoetin alfa.

Talk to your doctor about the risks of using darbepoetin alfa.

Patients with chronic renal failure:

Your doctor will adjust your dose of darbepoetin alfa so that your hemoglobin level (amount of a protein found in red blood cells) is between 10-12g/dL. If your hemoglobin level is higher than this, there is a greater risk that you will develop serious side effects including heart attack, stroke, heart failure, blood clots, and death. Call your doctor immediately if you experience any of the following symptoms: chest pain, squeezing pressure, or tightness; shortness of breath; nausea, lightheadedness, sweating, and other early signs of heart attack; discomfort or pain in the arms, shoulder, neck, jaw, or back; fast or irregular heartbeat; swelling of the hands, feet, or ankles; blue-grey coloring or darkening around mouth or nails; extreme tiredness or weakness; or fainting or loss of consciousness.

If you are receiving hemodialysis (treatment in which the blood is passed through a filter to remove wastes that would normally be removed by the kidneys), you may develop a blood clot in your vascular access (place on your body where your blood is removed and returned during dialysis). Call your doctor right away if you think you have a blood clot in your vascular access.

Cancer patients:

In clinical studies, people with certain cancers who received darbepoetin alfa died sooner or experienced tumor growth or cancer that spread sooner than people who did not receive the medication. If you have cancer, there is a risk that your tumor will grow faster or you will die sooner if you receive darbepoetin alfa, even if your hemoglobin level is kept lower than 12g/dL. To decrease these risks, you should receive the lowest possible dose of darbepoetin alfa and you should only receive darbepoetin alfa while you are receiving chemotherapy. Treatment with darbepoetin alfa should be stopped when your course of chemotherapy ends.

Why is this medication prescribed?   Return to top

Darbepoetin alfa is used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time). Darbepoetin alfa is also used to treat anemia caused by chemotherapy (medications to treat cancer). Darbepoetin alfa is in a class of medications called erythropoiesis-stimulating agents (ESAs). It works by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.

How should this medicine be used?   Return to top

Darbepoetin alfa comes as a solution (liquid) to inject subcutaneously (just under the skin) or intravenously (into a vein). It is usually injected once a week every 1 to 3 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use darbepoetin alfa exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor may start you on the lowest possible dose of darbepoetin alfa and gradually increase or decrease your dose, not more than once every month. Your doctor may also tell you to stop using darbepoetin alfa for a time. Follow these instructions carefully. If your doctor tells you to stop using darbepoetin alfa, do not begin using it again until your doctor tells you that you should. It is likely that your doctor will restart your treatment with a lower dose of darbepoetin alfa than you were using.

Darbepoetin alfa is used to reduce the need for red blood cell transfusions. Darbepoetin alfa controls anemia but does not cure it. It may take 2 to 6 weeks or longer before you feel the full benefit of darbepoetin alfa Continue to use darbepoetin alfa even if you feel well. Do not stop using darbepoetin alfa without talking to your doctor.

Darbepoetin alfa injections are usually given by a doctor or nurse. Your doctor may decide that you can inject darbepoetin alfa yourself, or that you may have a friend or relative give the injections. Your doctor will train the person who will be injecting the medication and will test him to be sure he can give the injection correctly. Be sure that you and the person who will be giving the injections know the correct dose, how to give the medication, and how often to give the medication. Be sure that you and the person who will be giving the injections read the manufacturer's information for the patient that comes with darbepoetin alfa before you use it for the first time at home.

Darbepoetin alfa comes in prefilled syringes and also in vials to use with disposable syringes. Use vials and prefilled or disposable syringes only once. Do not put a needle through the rubber stopper of a vial more than once. Throw away a vial, syringe, or prefilled syringe after one use, even if it is not empty. Throw away used syringes in a puncture-resistant container, out of the reach of children. Do not throw a filled container into the household trash or recycling. Talk to your doctor or pharmacist about how to throw away the puncture-resistant container. There may be special state and local laws for throwing away used needles and syringes.

If you are using vials of darbepoetin alfa, you will need to use disposable syringes to inject your medication. Your doctor or pharmacist will tell you what type of syringe you should use. Do not use any other type of syringe because you may not get the right amount of medication.

Always inject darbepoetin alfa solution in its own syringe; never mix it with any other medication.

If you are injecting darbepoetin alfa subcutaneously, you can inject it just under the skin anywhere on these parts of your body: the outer area of your upper arms, your stomach except for the 2-inch area around your navel (belly button), the front of your middle thighs, and the upper outer areas of your buttocks.

Choose a new spot each time you inject darbepoetin alfa. Do not inject darbepoetin alfa into a spot that is tender, red, bruised, hard, lumpy, or swollen.

Carefully read the manufacturer's instructions that describe how to prepare and inject a dose of darbepoetin alpha. Be sure to ask your pharmacist or doctor if you have any questions about how to prepare or inject this medication.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine   Return to top

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?   Return to top

Before using darbepoetin alfa,

What special dietary instructions should I follow?   Return to top

If you are following a prescribed special diet because you have kidney disease or high blood pressure, follow it carefully, even if you feel better while using darbepoetin alfa. Darbepoetin alfa will not work unless your body has enough iron. Your doctor or dietician will probably tell you to eat foods that are rich in iron. If you cannot get enough iron from your diet, your doctor may prescribe an iron supplement. Take this supplement exactly as directed.

What should I do if I forget a dose?   Return to top

Call your doctor to ask what to do if you miss a dose of darbepoetin alfa. Do not use a double dose to make up for a missed one.

What side effects can this medication cause?   Return to top

Darbepoetin alfa may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

Darbepoetin alfa may cause other side effects. Call your doctor if you have any unusual problems or you do not feel well while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?   Return to top

Keep this medication in the carton it came in, tightly closed, and out of reach of children. Once a vial or prefilled syringe has been taken out of its carton, keep it covered to protect it from room light until the dose is given. Store darbepoetin alfa in the refrigerator, but do not freeze it. Throw away any medication that has been frozen or is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

When traveling, pack darbepoetin alfa in its original carton in an insulated container with a coolant such as blue ice. To avoid freezing, make sure the darbepoetin alfa vial or prefilled syringe does not touch the coolant. Once you arrive, place darbepoetin alfa in a refrigerator as soon as possible.

In case of emergency/overdose   Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

What other information should I know?   Return to top

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using darbepoetin alfa.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names   Return to top

  • Aranesp®

Last Revised - 03/01/2008
Last Reviewed - 01/01/2005


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