Availability

Daunorubicin HCl 10 mg, 20 mg, 50 mg, 100 mg, 150 mg lyophilized vials; 2 mg/mL injection;

Daunorubicin Citrated Liposomal 2 mg/mL (equivalent to 50 mg daunorubicin base) injection

Actions

Cytotoxic and antimitotic glycoside antibiotic; cell-cycle specific for S-phase of cell division. Toxic properties preclude its use as an antibiotic. Mechanism of action unclear but may be due to rapid intercalating of DNA molecule resulting in inhibition of DNA, RNA, and protein synthesis.

Therapeutic Effects

A potent bone marrow suppressant with immunosuppressive properties as well as antineoplastic properties. It interferes with DNA and RNA synthesis. Induces cardiac toxicity and may be mutagenic and carcinogenic (development of secondary carcinomas).

Uses

To induce remission in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) in adults.

Unlabeled Uses

Solid tumors of childhood and non-Hodgkin's lymphoma.

Contraindications

Severe myelosuppression; immunizations (patient, family), and preexisting cardiac disease unless risk-benefit is evaluated; lactation; uncontrolled systemic infection. Safe use during pregnancy (category D) is not established.

Cautious Use

History of gout, urate calculi, hepatic or renal function impairment; older adult patients with inadequate bone reserve due to age or previous cytotoxic drug therapy, tumor cell infiltration of bone marrow, patient who has received potentially cardiotoxic drugs or related antineoplastics.

Route & Dosage

Neoplasms Adult: IV As a single agent, 30–60 mg/m2/d for 3–5 d q3–4wk  (max: total cumulative dose 500–600 mg/m2); As combination therapy, 30–45 mg/m2/d on days 1, 2, 3 of first course and days 1 and 2 of subsequent courses. Child: IV As combination therapy, 2 y, 25–45 mg/m2; <2 y, calculated on body weight (mg/kg) rather than body surface area Kaposi's Sarcoma (DaunoXome) Adult: IV 40 mg/m2 over 1 h, repeat q2wk (for serum bilirubin >3 mg/dL or Scr >3 mg/dL, administer half the normal dose)

Administration

PREPARE: IV Infusion: Each vial of DaunoXome contains the equivalent of 50 mg daunorubicin base. Dilute with enough D5W to produce a concentration of 1 mg/1 mL.  

ADMINISTER: IV Infusion: Give DaunoXome over 60 min. Do not use a filter with DaunoXome.  

INCOMPATIBILITIES Solution/additive: Dexamethasone, Heparin.

• Avoid extravasation because it can cause severe tissue necrosis.

• Store reconstituted solution at room temperature (15°–30° C; 59°–86° F) for 24 h and under refrigeration at 2°–8° C (36°–46° F) for 48 h. Protect from light.

Adverse Effects (1%)

Pharmacokinetics

Nursing Implications

Assessment & Drug Effects

• Monitor for therapeutic effectiveness. A profound suppression of bone marrow is required to induce a complete remission. Nadirs for thrombocytes and leukocytes are usually reached in 10–14 d.
• Monitor serum bilirubin; drug dose needs to be reduced when bilirubin is >1.2 mg/dL.
• Lab tests: Perform Hct, platelet count, total and differential leukocyte count, serum uric acid, chest x-ray, and cardiac, hepatic, and renal function tests prior to and periodically during therapy.
• Monitor BP, temperature, pulse, and respiratory function during treatment.
• Monitor for S&S of acute CHF. It can occur suddenly, especially when total dosage exceeds 550 mg/m², or in patients with compromised heart function because of previous radiation therapy to heart area.
• Report immediately: Breathlessness, orthopnea, change in pulse and BP parameters. Early clinical diagnosis of drug-induced CHF is essential for successful treatment.
• Report promptly S&S of superinfections including elevation of temperature, chills, upper respiratory tract infection, tachycardia, overgrowth with opportunistic organisms because myelosuppression imposes risk of superimposed infection (see Appendix F).
• Protect patient from contact with persons with infections. The most hazardous period is during nadirs of thrombocytes and leukocytes.
• Control nausea and vomiting (usually mild) by antiemetic therapy.
• Inspect oral membranes daily. Mucositis may occur 3–7 d after drug is administered.

Patient & Family Education

• Note: Loss of hair is probable; recovery is usual in 6–10 wk.
• Use barrier contraceptives during treatment because this drug is teratogic. Tell your physician immediately if you become pregnant during therapy.
• Note: A transient effect of the drug is to turn urine red on the day of infusion.
• Do not breast feed while taking this drug.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug