DAUNORUBICIN CITRATED LIPOSOMAL
Classifications: antineoplastic; antibiotic; anthracycline; Therapeutic: antineoplastic
Prototype: Doxorubicin HCl
Pregnancy Category: D
Daunorubicin HCl: 10 mg, 20 mg, 50 mg, 100 mg lyophilized vials;
Daunorubicin Citrated Liposomal: 2 mg/mL (equivalent to 50 mg daunorubicin base) injection
Cytotoxic and antimitotic anthracycline antibiotic that is cell-cycle specific for S-phase of cell division. Toxic properties
preclude its use as an antibiotic. Mechanism of action is due to rapid interaction with the DNA molecule changing its shape,
thus resulting in inhibition of DNA, RNA, and protein synthesis.
Antineoplastic effects against acute leukemias with decreased incidence of cardiotoxicity than doxorubicin.
To induce remission in acute nonlymphocytic/lymphocytic leukemia, advanced HIV-associated Kaposi's sarcoma.
Severe myelosuppression; immunizations (patient, family), and preexisting cardiac disease unless risk-benefit is evaluated;
uncontrolled systemic infection; pregnancy (category D), lactation.
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
Adult: IV <60 y, 45 mg/m2/d on days 1, 2, and 3 of first course then days 1 and 2 of subsequent courses (max: total cumulative dose 500600
mg/m2); ≥60 y, 30 mg/m2/d on days 1, 2, and 3 of first course then days 1 and 2 of subsequent courses
Child: IV As combination therapy, ≥2 y, 25 mg/m2 weekly; <2 y, 1 mg/kg
Kaposi's Sarcoma (DaunoXome)
Adult: IV 40 mg/m2 over 1 h, repeat q2wk (withhold therapy if granulocyte count <750 cells/mm3)
If serum Cr >3 mg/dL, give 50% of dose.
For total bilirubin 1.23 mg/dL, give 50% of dose; >35 mg/dL, give 25% of dose; >5 mg/dL, omit dose
- Use gloves during preparation for infusion to prevent skin contact with this drug. If contact occurs, decontaminate skin
with copious amounts of water with soap.
PREPARE: Direct: ??Reconstitute 20 mg vial with 4 mL sterile water for injection. The concentration of the solution will be 5 mg/mL.??Withdraw dose into syringe containing 1015 mL normal saline. IV Infusion: Dilute further in 100 mL NS as required.
ADMINISTER: Direct: Inject over approximately 3 min into the tubing or side arm of a rapidly flowing IV infusion of D5W or NS. Infusion: Give a single dose over 3045 min.
Specific to DaunoXome
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. Y-site: Allopurinol, aztreonam, cefepime, fludarabine, lansoprazole, piperacillin/tazobactam.
- 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%)Body as a Whole:
Amnesia, anxiety, ataxia, confusion, hallucinations, emotional lability, tremors. CV:
Pericarditis, myocarditis, arrhythmias, peripheral edema, CHF, hypertension, tachycardia. GI: Acute nausea and vomiting
(mild), anorexia, stomatitis,
mucositis, diarrhea (occasionally) hemorrhage. Urogenital:
Dysuria, nocturia, polyuria, dry skin. Hematologic: Bone marrow depression thrombocytopenia, leukopenia,
(reversible), transverse pigmentation of nails, severe cellulitis or tissue necrosis at site of drug extravasation. Endocrine:
Hyperuricemia, gonadal suppression.
Highest concentrations in spleen, kidneys, liver, lungs, and heart; does not cross bloodbrain barrier; crosses placenta. Metabolism:
In liver to active metabolite. Elimination:
25% in urine, 40% in bile. Half-Life:
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 1014 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
- Control nausea and vomiting (usually mild) by antiemetic therapy.
- Inspect oral membranes daily. Mucositis may occur 37 d after drug is administered.
Patient & Family Education
- Note: Loss of hair is probable; recovery is usual in 610 wk.
- Use barrier contraceptives during treatment because this drug is teratogenic. 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.