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(DAW-no-RUE-bih-sin)

Cerubidine

Lyophilized powder for injection

20 mg vial with 100 mg mannitol added.

Solution for injection

5 mg/mL, 4 mL vial.

Class: Antineoplastic

Anthracycline antibiotic

 Actions Antimitotic and cytotoxic activity.

 Indications Acute lymphocytic leukemia.

Chronic myelogenous leukemia, Kaposi sarcoma.

 Contraindications None well documented.

 Route/Dosage

Acute Nonlymphocytic Leukemia (Combination Therapy)

Adults (under 60 yr): IV Daunorubicin 45 mg/m²/day on days 1 to 3 of first course and days 1 to 2 of subsequent courses. May require up to 3 courses.

Adults (over 60 yr): IV Daunorubicin 30 mg/m²/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)

ADULTS: IV Daunorubicin 45 mg/m²/day on days 1 to 3.

Acute Lymphocytic Leukemia

Children (at least 2 yr): IV Daunorubicin 25 mg/m² on day 1 q 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 (under 2 yr or under 0.5 m² BSA): IV Calculate dosage on the basis of weight (mg/kg) instead of BSA.

Dosage Adjustment for Renal or Hepatic Function

If 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 Increases

ADULTS: IV No more than 550 mg/m².

Adults having received mediastinal radiation: IV No more than 400 mg/m².

Children (at least 2 yr): IV No more than 300 mg/m².

Children (under 2 yr): IV No more than 10 mg/m².

Interactions

Cyclophosphamide

May result in increased daunorubicin toxicity.

Hepatotoxic medications

May impair liver function and increase the risk of toxicity.

Myelosuppressive agents

Dosage reduction of daunorubicin may be required.

Quinolone antibiotics

Daunorubicin may decrease the oral absorption of quinolone antibiotics.

Lab Test Interferences

Hyperuricemia

May be induced secondary to a rapid lysis of leukemic cells. As a precaution, administer allopurinol prior to initiating antileukemic therapy.

 Adverse Reactions

CARDIOVASCULAR: Delayed dose-related cardiomyopathy; acute arrhythmias. DERMATOLOGIC: Alopecia; rash; contact dermatitis; urticaria; radiation recall; nail hyperpigmentation. GI: Nausea; vomiting; mucositis; esophagitis; diarrhea; abdominal pain. HEMATOLOGIC: Bone marrow suppression. HYPERSENSITIVITY: Anaphylaxis. OTHER: Fever; chills.

 Precautions

Pregnancy: Category D. Lactation: Advise mothers to discontinue nursing. Children: Cardiotoxicity may be more frequent and occur at lower cumulative doses. Elderly: Cardiotoxicity may be more frequent. Use caution in patients who have inadequate bone marrow reserves because of old age. Adjustment in renal or hepatic insufficiency: Some health care providers recommend not giving daunorubicin to patients with a bilirubin above 5 mg/dL. Extravasation risk: Local irritation of phelebitis may occur. Refer to the institution’s specific protocol. Health care provider administration: It is recommended that daunorubicin be administered only by health care providers who are experienced in leukemia chemotherapy. Myelosuppression: Occurs when used in therapeutic doses; this may lead to infection or hemorrhage. Myocardial toxicity: Potentially fatal CHF may occur when total cumulative dosage exceeds 400 to 550 mg/m² in adults, 300 mg/m² in children above 2 yr, or 10 mg/kg in children under 2 yr. This may occur during therapy or several months to years after therapy. Previous cumulative dose: Do not use in patients who have previously received the recommended maximum cumulative dose of either doxorubicin or daunorubicin. Renal and hepatic function impairment: Reduce doses. Secondary leukemias: There have been reports of secondary leukemias in patients exposed to daunorubicin when used in combination with other antineoplastic agents or radiation therapy.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

• Store powder at room temperature (59° to 86°F). Protect from light.
• Refrigerate unopened vials of solution. Protect from light.
• Reconstitute vials of powder with Sterile Water for Injection for a final concentration of 5 mg/mL. Shake vial gently to dissolve contents. Maximum concentration of daunorubicin for administration is 5 mg/mL; more concentrated solutions are hyperosmolar.
• Withdraw the desired dose into a syringe containing 10 to 15 mL of normal saline; inject into a rapidly flowing IV infusion of 5% glucose or normal saline solution.
• Although reconstituted solution is chemically stable under refrigeration longer, it contains no preservative; use within 24 hr. Protect from sunlight.
• Color change of solution from red to blue-purple indicates decomposition.
• Administer by IV push or IV infusion.
• Dilute 5 mg/mL solution with 10 to 15 mL of 0.9% Sodium Chloride. Give by direct IV injection or by IV side arm.
• Reconstituted solution has also been diluted in 100 mL of 5% Dextrose or 0.9% Sodium Chloride and infused IV over 30 to 45 min. However, many health care providers consider the risk of extravasation unacceptable unless infused through a central venous catheter.
• Do not mix with other drugs or heparin.

 Assessment/Interventions

• Attaining a normal appearing bone marrow may require no more than 3 courses of induction therapy. Evaluate bone marrow following recovery from the previous induction course to determine the need for a further course of induction treatment.
• 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 wth significant risk of drug-induced cardiomyopathy. Perform an ECG or determine systolic ejection fraction before each course.
• Assess hepatic and renal function prior to each course of therapy.
• Observe patient closely and monitor chemical and laboratory tests extensively.
• Monitor serum uric acid. Minimize effects of hyperuricemia with hydration, urinary alkalinization, and allopurinol.
• Urine discoloration (red) may occur.

 Patient/Family Education

• Explain name, action, and potential side effects of drug.
• Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
• Advise patient, family, or caregiver that medication may be used in combination with other agents to achieve maximum benefit possible.
• Review dosing schedule with patient, family, or caregiver.
• Advise patient, family, or caregiver that medication will usually cause a red coloration of the urine. Advise that this is not a problem and is expected because the medication is being eliminated in the urine.
• Advise patient, family, or caregiver that medication may cause hair loss but that this is reversible when therapy is stopped.
• Advise patient, family, or caregiver to immediately report any of the following to health care provider: rash; hives; difficulty breathing; chest pain; fever, chills, or other signs of infection; sores in mouth; unusual bleeding or bruising; pain, redness or swelling at injection site.
• Advise patient, family, or caregiver to report any of the following to health care provider: persistent nausea, vomiting or appetite loss; persistent or worsening general body weakness.
• Instruct patient to not take any prescription or otc medications or dietary supplements unless advised by health care provider.
• Caution women of childbearing potential to avoid becoming pregnant while being treated.
• Instruct women of childbearing potential to notify health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
• Advise patient that following discharge from the hospital that frequent follow-up visits, ECGs, or heart function tests, and laboratory tests will be required to monitor therapy and to keep appointments.

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