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
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What is the most important information I should know about daunorubicin?

Daunorubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of daunorubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with daunorubicin.

What is daunorubicin?

Daunorubicin is a cancer (antineoplastic) medication. Daunorubicin interferes with the growth of cancer cells and slows their growth and spread in the body.

Daunorubicin is used in the treatment of leukemia (blood cancer).

Daunorubicin may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using daunorubicin?

Do not use daunorubicin without first talking to your doctor if you have

The use of daunorubicin may be dangerous if you have any of the conditions listed above.

Daunorubicin is in the FDA pregnancy category D. This means that daunorubicin is known to be harmful to an unborn baby. Do not use daunorubicin without first talking to your doctor if you are pregnant. Discuss with your doctor the appropriate use of birth control during treatment with daunorubicin if necessary. Daunorubicin passes into breast milk and may harm a nursing baby. Breast-feeding should be avoided during treatment with daunorubicin. Children have an increased risk of heart problems due to treatment with daunorubicin. Growth and gonadal development may also be affected.
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