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Drug Notebook

FDA Alerts

    Extravasation
  • Severe local tissue necrosis if extravasation occurs. Do not administer IM or sub-Q. (See Local Effects under Cautions.)

    Myocardial Toxicity
  • Possible cardiotoxicity and potentially fatal CHF during or months to years after therapy; increased risk with cumulative dosages >400–550 mg/m2 in adults, >300 mg/m2 in children >2 years of age, or >10 mg/kg in children <2 years of age. (See Cardiotoxicity under Cautions.)
  • Monitor cardiac function regularly, especially in patients with pre-existing cardiac disease or those who have received prior anthracyclines or have had prior radiotherapy encompassing the heart.

    Myelosuppression
  • Severe myelosuppression may occur, possibly resulting in infection or hemorrhage. (See Hematologic Effects under Cautions.)

    Hepatic and Renal Impairment
  • Reduce dosage in patients with hepatic or renal impairment. (See Special Populations under Dosage and Administration.)

    Experience of Supervising Clinician
  • Administer only under the supervision of qualified clinician experienced in the use of antineoplastic agents. Use only when adequate treatment facilities for appropriate management of therapy and complications are available.

    Infusion-related Effects
  • Triad of back pain, flushing, and chest tightness reported in patients receiving liposomal daunorubicin citrate; generally occurs during first 5 minutes of infusion, subsides with infusion interruption, and generally does not recur if infusion resumed at slower rate. (See Infusion-related Effects under Cautions.)

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DAUNOrubicin
(daw noe ROO bi sin)

What is this medicine?
DAUNORUBICIN (daw noe ROO bi sin) is a chemotherapy drug. This medicine is used to treat acute leukemias.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
  • signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
  • signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
  • signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
  • breathing problems
  • chest pain
  • gout pain
  • fast, irregular heartbeat
  • mouth sores
  • pain, swelling, redness at site where injected
  • swelling of ankles, feet, or hands
  • unusual bleeding or bruising

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • diarrhea
  • hair loss
  • loss of appetite
  • nausea, vomiting
  • red colored urine
  • stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional. If you have pain, swelling, burning or any unusual feeling around the site of your injection, tell your health care professional right away.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

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What may interact with this medicine?
Do not take this medicine with any of the following medications:

  • chloroquine
  • cisapride
  • droperidol
  • halofantrine
  • pimozide

This medicine may also interact with the following medications:

  • chlorpromazine
  • clarithromycin
  • cyclophosphamide
  • cyclosporine
  • erythromycin
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for irregular heart beat like amiodarone, bepridil, dofetilide, encainide, flecainide, propafenone, quinidine
  • medicines for nausea, vomiting like dolasetron, ondansetron, palonosetron
  • medicines to increase blood counts like filgrastim, pegfilgrastim, sargramostim
  • methadone
  • methotrexate
  • pentamidine
  • vaccines

Talk to your doctor or health care professional before taking any of these medicines:

  • acetaminophen
  • aspirin
  • ibuprofen
  • ketoprofen
  • naproxen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Who should NOT use this medication?

  • Hypersensitivity to daunorubicin or any ingredient in the formulation.

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What should I watch for while using this medicine?
Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work done while you are taking this medicine.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

You urine may turn red for a few days after your dose. This is not blood. If your urine is dark or brown, call your doctor.

In some cases, you may be given additional medicines to help with side effects. Follow all directions for their use.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

Men may have a lower sperm count while taking this medicine. Talk to your doctor if you plan to father a child.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • blood disorders
  • heart disease
  • infection (especially a virus infection such as chickenpox, cold sores, or herpes)
  • kidney disease
  • liver disease
  • recent or ongoing radiation therapy
  • an unusual or allergic reaction to daunorubicin, other chemotherapy agents, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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