Generic Name: darbepoetin alfa (polysorbate 80) (DAR-be-POE-e-tin AL-fa (POL-ee-SOR-bate))
Brand Name: Aranesp

Clinical studies have shown Aranesp to increase the risk of serious side effects (eg, blood clots, stroke, heart attack, heart failure) and death in some cases. It has also been shown to shorten overall survival and/or increase the risk of tumor growth or recurrence in patients with certain types of cancer. Talk with your doctor about the risks and benefits of using Aranesp. Do not use more than the recommended dose without checking with your doctor.


Aranesp is used for:

Treating anemia in certain patients with chronic kidney disease. It is also used to treat anemia caused by chemotherapy in certain cancer patients. It may also be used for other conditions as determined by your doctor.

Aranesp is a synthetic erythropoietin analog. It works by stimulating the bone marrow to produce more red blood cells.

Do NOT use Aranesp if:

  • you are allergic to any ingredient in Aranesp, including if you have had a severe allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness) to Aranesp
  • you have uncontrolled high blood pressure
  • you have developed a certain type of anemia called pure red cell aplasia (PRCA) after receiving a previous dose of Aranesp or other erythropoietin protein medicines (eg, epoetin)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Aranesp:

Some medical conditions may interact with Aranesp. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances, including latex
  • if you have a history of cancer, seizures, kidney problems (eg, decreased kidney function, kidney failure), blood problems (eg, sickle cell anemia, porphyria, hemolytic anemia, thalassemia), bleeding or clotting problems, stroke, heart attack or other heart problems (eg, congestive heart failure, ischemic heart disease), diabetes, or high blood pressure
  • if you have blood in your stools; an inflection or recent injury; certain bone problems (eg, osteofibrosis cystica); an inflammatory condition (eg, bowel disease, rheumatoid arthritis); low blood iron, folic acid, or vitamin B12 levels; or high blood aluminum levels
  • if you are on hemodialysis, have recently had surgery, or are scheduled to have surgery

Some MEDICINES MAY INTERACT with Aranesp. Tell your health care provider if you are taking any other medicine.

Ask your health care provider if Aranesp may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aranesp:

Use Aranesp as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Aranesp comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Aranesp refilled.
  • Aranesp is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Aranesp at home, a health care provider will teach you how to use it. Be sure you understand how to use Aranesp. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use Aranesp if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Do not shake Aranesp. Do not use Aranesp if it has been shaken.
  • Do not use Aranesp if it has been frozen.
  • Do not dilute or mix Aranesp with any other solutions or medicines.
  • Discard any unused portion of medicine left in the vial or syringe.
  • Use only disposable syringes and needles. Use the syringes and needles only once and dispose of them in a puncture-proof container as instructed by your health care provider.
  • Choose a new site each time you inject Aranesp. Do not inject into an area that is tender, red, bruised, hard, swollen, or has scars or stretch marks.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Aranesp, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Aranesp.

Important safety information:

  • Aranesp may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Aranesp with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT use more than the recommended dose without checking with your doctor.
  • It is important to keep your blood pressure under control while you use Aranesp. Do not stop taking any of your blood pressure medicines without checking with your doctor. Closely follow your doctor's instructions for diet and blood pressure monitoring.
  • It may take 2 to 6 weeks for Aranesp to work. Do not stop taking Aranesp without checking with your doctor.
  • Tell your doctor immediately if symptoms of anemia persist or recur, such as increased fatigue/weakness or pale skin color.
  • Lab tests, including blood pressure, kidney function, hemoglobin levels, and iron studies, may be performed while you use Aranesp. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Aranesp should be used with extreme caution in CHILDREN younger than 1 year old with chronic kidney disease or in CHILDREN with cancer; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aranesp while you are pregnant. It is not known if Aranesp is found in breast milk. If you are or will be breast-feeding while you use Aranesp, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Aranesp:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; mild pain at the injection site; mild stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest, jaw, or left arm pain; confusion; coughing up blood; fainting; fast or irregular heartbeat; new or worsening pale skin color, or tiredness or weakness; numbness of an arm or leg; one-sided weakness; redness, pain, tenderness, or swelling of the calf or leg; seizures; severe or persistent pain or irritation at the injection site; severe or persistent stomach pain; shortness of breath; sudden, severe headache, dizziness, or vomiting; sudden trouble walking or loss of balance or coordination; swelling of the arms or legs; vision or speech problems; weight gain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe or persistent headache or dizziness.

Proper storage of Aranesp:

Aranesp is usually handled and stored by a health care provider. If you are using Aranesp at home, store Aranesp as directed by your pharmacist or health care provider. Keep Aranesp out of the reach of children and away from pets.

General information:

  • If you have any questions about Aranesp, please talk with your doctor, pharmacist, or other health care provider.
  • Aranesp is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Aranesp or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aranesp. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aranesp. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Aranesp.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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