Trade Names:Cerubidine- Lyophilized powder for injection 20 mg vial with 100 mg mannitol added- Solution for injection 5 mg/mL, 4 mL vial
Antimitotic and cytotoxic activity.
Extensive and rapid protein binding. Highest concentrations in spleen, kidneys, liver, lungs, and heart.
Extensively metabolized in liver and other tissues to daunorubicinol (active).
t ½ is 18.5 h (daunorubicin) and 26.7 h (daunorubicinol). Approximately 25% excreted in active form in the urine and 40% by biliary excretion.
Acute lymphocytic leukemia.
Chronic myelogenous leukemia, Kaposi sarcoma.
None well documented.
IV Daunorubicin 45 mg/m 2 /day on days 1 to 3 of first course and days 1 to 2 of subsequent courses. May require up to 3 courses.
Adults (older than 60 yr of age)IV Daunorubicin 30 mg/m 2 /day on days 1 to 3 of first course and days 1 to 2 of subsequent courses. May require 3 courses.
Acute Lymphocytic Leukemia (Combination Therapy)AdultsIV Daunorubicin 45 mg/m 2 /day on days 1 to 3.
Acute Lymphocytic LeukemiaChildren (2 yr of age and older)IV Daunorubicin 25 mg/m 2 on day 1 every wk with vincristine and oral prednisone. Generally, complete remission will be obtained with 4 courses of therapy. If after 4 courses the patient is in partial remission, an additional 1 or, if necessary, 2 courses may be given.
Children (younger than 2 yr of age or under 0.5 m 2 BSA)IV Calculate dosage on the basis of weight (mg/kg) instead of BSA.
Dosage Adjustment for Renal or Hepatic Function ImpairmentIf serum bilirubin is 1.2 to 3 mg/dL, then give 75% of adjusted dose from prior course. If serum bilirubin is above 3 mg/dL or serum creatinine is above 3 mg/dL, then give 50% of adjusted dose from prior course.
Lifetime Cumulative Doses Above Which Frequency of Cardiotoxicity IncreasesAdultsIV No more than 550 mg/m 2 .
Adults having received mediastinal radiationIV No more than 400 mg/m 2 .
Children (2 yr of age and older)IV No more than 300 mg/m 2 .
Children (younger than 2 yr of age)IV No more than 10 mg/m 2 .
Store powder at room temperature (59° to 86°F). Protect from light. Refrigerate unopened vials of solution. Protect from light.
May result in increased daunorubicin toxicity.
Hepatotoxic medicationsMay impair liver function and increase the risk of toxicity.
Myelosuppressive agentsDosage reduction of daunorubicin may be required.
Quinolone antibioticsDaunorubicin may decrease the oral absorption of quinolone antibiotics.
May be induced secondary to a rapid lysis of leukemic cells. As a precaution, administer allopurinol prior to initiating antileukemic therapy.
Delayed dose-related cardiomyopathy; acute arrhythmias.
Alopecia; rash; contact dermatitis; urticaria; radiation recall; nail hyperpigmentation.
Nausea; vomiting; mucositis; esophagitis; diarrhea; abdominal pain.
Bone marrow suppression.
Anaphylaxis.
Fever; chills.
Category D .
Advise mothers to discontinue nursing.
Cardiotoxicity may be more frequent and occur at lower cumulative doses.
Cardiotoxicity may be more frequent. Use caution in patients who have inadequate bone marrow reserves because of old age.
Some health care providers recommend not giving daunorubicin to patients with a bilirubin above 5 mg/dL. Reduce dose.
Some health care providers recommend not giving daunorubicin to patients with a bilirubin above 5 mg/dL. Reduce dose.
Monitor ECG and systolic ejection fraction as the maximum cumulative lifetime dose approaches. Certain ECG changes and a decrease in the systolic injection fraction from pretreatment baseline may aid in recognizing those patients at greatest risk. A decrease of at least 30% in limb lead QRS voltage has been associated with significant risk of drug-induced cardiomyopathy. Perform an ECG or determine systolic ejection fraction before each course.
Local irritation of phlebitis may occur. Refer to the institution's specific protocol.
It is recommended that daunorubicin be administered only by health care providers who are experienced in leukemia chemotherapy.
Occurs when used in therapeutic doses; this may lead to infection or hemorrhage.
Potentially fatal CHF may occur when total cumulative dosage exceeds 400 to 550 mg/m 2 in adults, 300 mg/m 2 in children older than 2 yr of age, or 10 mg/kg in children younger than 2 yr of age. This may occur during therapy or several months to years after therapy.
Do not use in patients who have previously received the recommended maximum cumulative dose of either doxorubicin or daunorubicin.
There have been reports of secondary leukemias in patients exposed to daunorubicin when used in combination with other antineoplastic agents or radiation therapy.
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