DAUNOrubicin hydrochloride (daw-noe-roo-bi-sin hye-droklor- ide) Cerubidine

 Indications

In combination with other antineoplastics in the treatment

of leukemias.

Action

Forms a complex with DNA, which subsequently inhibits

DNA and RNA synthesis (cell-cycle phase-nonspecific).

Therapeutic Effects: Death of rapidly replicating

cells, particularly malignant ones. Also has

immunosuppressive properties.

Pharmacokinetics

Absorption: Administered IV only, resulting in complete

bioavailability.

Distribution: Widely distributed. Crosses the placenta.

Metabolism and Excretion: Extensively metabolized

by the liver. Converted partially to a compound

that also has antineoplastic activity (daunorubicinol);

40% eliminated by biliary excretion.

Half-life: Daunorubicin —18.5 hr. Daunorubicinol—

26.7 hr.

TIME/ACTION PROFILE (effects on blood

counts)

ROUTE ONSET PEAK DURATION

IV 7–10 days 10–14 days 21 days

Contraindications/Precautions

Contraindicated in: Hypersensitivity to daunorubucin

or any other components in the formulation;

Symptomatic HF/arrhythmias; Pregnant or lactating

women.

Use Cautiously in: Active infections or decreased

bone marrow reserve; Geriatric patients or patients

with other chronic debilitating illnesses (dosage reduction

recommended for patients 60 yr); May reactivate

skin lesions produced by previous radiation therapy;

Hepatic or renal impairment (dosage reduction recommended

if serum creatinine 3 m g/dL or serum bilirubin

1.2 m g/dL); Patients who have received previous

anthracycline therapy or who have underlying cardiovascular

disease (increased risk of cardiotoxicity); Patients

with child-bearing potential.

Adverse Reactions/Side Effects

EENT: rhinitis, abnormal vision, sinusitis. CV: CARDIOTOXICITY,

arrhythmias. GI: nausea, vomiting, esophagitis,

hepatoxicity, stomatitis. GU: red urine, gonadal

suppression. Derm: alopecia. Hemat: anemia, leukopenia,

thrombocytopenia. Local: phlebitis at IV site.

Metab: hyperuricemia. Misc: chills, fever.

Interactions

Drug-Drug: Additive myelosuppression with other

antineoplastics. May decrease antibody response to

live-virus vaccines and increase risk of adverse reactions.

Cyclophosphamide increases the risk of cardiotoxicity.

Increased risk of hepatic toxicity with other

hepatotoxic agents.

Route/Dosage

Other dose regimens are used. In adults, cumulative

dose should not exceed 550 mg/m2 (450 mg/m2 if previous

chest radiation).

IV (Adults 60 yr): 45 mg/m2/day for 3 days in first

course, then for 2 days of second course (as part of

combination regimen).

IV (Adults 60 yr): 30 mg/m2/day for 3 days in first

course, then for 2 days of second course (as part of

combination regimen).

IV (Children 2 yr): 25 mg/m2 once weekly (as part

of combination regimen). In children 2 yr or BSA

0.5 m2, dosage should be determined on a mg/kg basis.

Availability (generic available)

Powder for injection: 20 mg/vial. Solution for

injection: 5 mg/mL.