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Darbepoetin Alfa

(dar-beh-poe-uh-tin al-fa)

Trade/other name(s): Aranesp

Why would this drug be used?

Darbepoetin alfa is used to prevent or treat anemia (low red blood cell counts), which can result from cancer chemotherapy. Because this drug usually takes at least a couple of weeks to work, it does not help people who need their red blood cell levels raised right away.

How does this drug work?

Darbepoetin alfa is a long-acting, man-made version of a hormone protein called erythropoietin. This protein is normally made by the kidneys to stimulate the bone marrow to make more red blood cells. The man-made version has the same effect when injected into the body.

Before taking this medicine

Tell your doctor…

  • If you are allergic to any medicines, dyes, additives, or foods.
  • If you have ever had high blood pressure. This drug may raise blood pressure. Your doctor will want to monitor you closely during treatment.
  • If you have ever had heart disease or blood clots. This drug may raise your risk of heart attacks, strokes, or other problems linked to blood clotting.
  • If you have ever had seizures. This drug may raise your risk of seizures.
  • If you have any other medical conditions such as kidney disease, liver disease (including hepatitis), thyroid problems, congestive heart failure, diabetes, gout, or infections. This drug may make some of these conditions worse. You may need closer monitoring of these conditions while being treated, or the drug dose, regimen, or timing may need to be changed.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. Though animal studies showed only a small reduction in the weight of the offspring, no studies have been done in pregnant women. This drug should be used during pregnancy only if the expected benefit is thought to justify the potential risk to the fetus.
  • If you are breast-feeding. It is not yet known if this drug passes into breast milk, but if it does, it may affect the baby. Talk with your doctor about the possible risks of breast-feeding while taking this drug.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

No serious interactions with other drugs are known at this time. But this does not necessarily mean that none exist. Check with your doctor, nurse, or pharmacist about all of your medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether some foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Darbepoetin alfa is usually given as a shot under the skin (subcutaneously, or SubQ). It may also be given as part of an intravenous (IV) infusion. It is injected either weekly or every 3 weeks. It is usually given in a doctor's office, although in rare cases you or a family member may be able to learn how to give the shot at home.

The dose and treatment schedule will depend on your weight, general health, hemoglobin level (a lab test of your red blood cell levels), and the reason you are being treated. The dose and/or schedule may be changed based on how your body responds to treatment.

If you are taking it at home, make sure to keep the medicine in its original container in the refrigerator. Take this drug exactly as directed by your doctor. If you are not sure of the instructions, ask your doctor or nurse to explain them to you. Keep the needles and other equipment in a safe place out of reach of children and pets. Keep used needles in a closed needle bucket and take them back to your doctor or nurse.

Precautions

This drug is approved for use in cancer patients who are currently getting chemotherapy for their cancer. It should not be used in people whose treatment is expected to cure their cancer.

It is very important that this drug is used as directed and for the shortest time needed to control anemia symptoms, especially in cancer patients. In studies that have aimed at raising the hemoglobin level (a measure of red blood cells) above 12 g/dL, some patients getting this or similar drugs have had tumor growth or shorter survival.

Patients with acute myeloid leukemia (AML) or chronic myelogenous leukemia (CML) should not get this drug, as it could potentially spur the growth of these types of cancer cells.

Some people with breast cancer, non-small cell lung cancer, head and neck cancer, lymphoma, cervical cancer, multiple myeloma, or lymphocytic leukemia may have a risk of shorter survival or re-growth of their cancer if they use this type of drug.

This drug may cause high blood pressure or make existing high blood pressure worse. If you are taking a drug for high blood pressure, talk to your doctor about this. Your blood pressure will probably be checked during treatment, and you may need medicine to help control it if it goes up. Tell your doctor right away if you notice any possible symptoms of high blood pressure, including a severe headache, chest pain, or feeling dizzy or light-headed.

This drug may slightly increase your risk of heart attack, stroke, or major blood clots in the the legs or lungs. These can be serious or life-threatening. Your doctor may prescribe a "blood-thinning" medicine to help reduce this risk. Tell your doctor right away if you notice chest pain, shortness of breath, severe headache, or changes in vision or sensation. Call your doctor if you notice an arm or leg that looks pale or cool, or if you have pain, with or without swelling in an arm or leg. Get emergency help for signs of stroke such as numbness, confusion, trouble speaking or understanding others, trouble with walking or balance, or fainting.

This drug may raise your risk of seizures slightly, especially during the first few months while taking it. Use caution when driving or operating heavy machinery during this time.

Your doctor will obtain blood tests as often as once a week at first, to find out how you respond to the drug. Your doctor will adjust your dose or your medicines based on your test results. Keep all your appointments for doctor visits and blood tests.

In rare cases, a person's immune system may react to this drug, which can lead to severe anemia (very low red blood cell counts). Tell your doctor or nurse right away if you start to feel very tired or weak.

In rare cases, this drug can cause allergic reactions when the drug is given, especially with the first few treatments. Mild reactions may consist of fever, chills, skin itching, or feeling flushed. More serious reactions happen rarely, but can be dangerous. Symptoms can include feeling lightheaded or dizzy (due to low blood pressure), chest tightness, shortness of breath, back pain, or swelling of the face, tongue, or throat. If you have symptoms like these, stop using the drug and call your doctor or get medical help right away

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • fever
  • swelling in the face, hands, or feet

Less common

  • diarrhea
  • high blood pressure*
  • dizziness
  • headache
  • nausea/vomiting
  • joint or muscle pain
  • feeling weak
  • upper respiratory infection (cough, sneezing, sore throat, etc.)

Rare

  • shortness of breath
  • rash
  • seizure*
  • heart attack, stroke, or major blood clot*
  • clotting in venous access device (Portacath, PICC line, or other)
  • severe anemia (very low red blood cell count)*
  • allergic reaction*
  • shortened survival*
  • tumor growth or recurrence*
  • death from heart attack, stroke, blood clot in the lungs, or tumor growth

*See "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2001.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 11/19/2009
Last Revised: 08/15/2011