Darbepoetin alfa (polysorbate 80)

Pronunciation

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

Clinical studies have shown darbepoetin alfa (polysorbate 80) 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 darbepoetin alfa (polysorbate 80). Do not use more than the recommended dose without checking with your doctor.


Darbepoetin alfa (polysorbate 80) 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.

Darbepoetin alfa (polysorbate 80) is a synthetic erythropoietin analog. It works by stimulating the bone marrow to produce more red blood cells.

Do NOT use darbepoetin alfa (polysorbate 80) if:

  • you are allergic to any ingredient in darbepoetin alfa (polysorbate 80), 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 darbepoetin alfa (polysorbate 80)
  • 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 darbepoetin alfa (polysorbate 80) 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 darbepoetin alfa (polysorbate 80):

Some medical conditions may interact with darbepoetin alfa (polysorbate 80). 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 darbepoetin alfa (polysorbate 80). Tell your health care provider if you are taking any other medicine.

Ask your health care provider if darbepoetin alfa (polysorbate 80) 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 darbepoetin alfa (polysorbate 80):

Use darbepoetin alfa (polysorbate 80) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Darbepoetin alfa (polysorbate 80) comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get darbepoetin alfa (polysorbate 80) refilled.
  • Darbepoetin alfa (polysorbate 80) is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using darbepoetin alfa (polysorbate 80) at home, a health care provider will teach you how to use it. Be sure you understand how to use darbepoetin alfa (polysorbate 80). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use darbepoetin alfa (polysorbate 80) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Do not shake darbepoetin alfa (polysorbate 80). Do not use darbepoetin alfa (polysorbate 80) if it has been shaken.
  • Do not use darbepoetin alfa (polysorbate 80) if it has been frozen.
  • Do not dilute or mix darbepoetin alfa (polysorbate 80) 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 darbepoetin alfa (polysorbate 80). 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 darbepoetin alfa (polysorbate 80), contact your doctor right away.

Ask your health care provider any questions you may have about how to use darbepoetin alfa (polysorbate 80).

Important safety information:

  • Darbepoetin alfa (polysorbate 80) may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use darbepoetin alfa (polysorbate 80) 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 darbepoetin alfa (polysorbate 80). 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 darbepoetin alfa (polysorbate 80) to work. Do not stop taking darbepoetin alfa (polysorbate 80) 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 darbepoetin alfa (polysorbate 80). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Darbepoetin alfa (polysorbate 80) 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 darbepoetin alfa (polysorbate 80) while you are pregnant. It is not known if darbepoetin alfa (polysorbate 80) is found in breast milk. If you are or will be breast-feeding while you use darbepoetin alfa (polysorbate 80), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of darbepoetin alfa (polysorbate 80):

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 darbepoetin alfa (polysorbate 80):

Darbepoetin alfa (polysorbate 80) is usually handled and stored by a health care provider. If you are using darbepoetin alfa (polysorbate 80) at home, store darbepoetin alfa (polysorbate 80) as directed by your pharmacist or health care provider. Keep darbepoetin alfa (polysorbate 80) out of the reach of children and away from pets.

General information:

  • If you have any questions about darbepoetin alfa (polysorbate 80), please talk with your doctor, pharmacist, or other health care provider.
  • Darbepoetin alfa (polysorbate 80) 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 darbepoetin alfa (polysorbate 80) 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 darbepoetin alfa (polysorbate 80). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to darbepoetin alfa (polysorbate 80). 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 darbepoetin alfa (polysorbate 80).

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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