Daunorubicin

What it is and how it works

Mechanism of Action Daunorubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action. Daunorubicin forms complexes with DNA by intercalation between base pairs. It inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, preventing the religation portion of the ligation-religation reaction that topoisomerase II catalyzes. Single strand and double strand DNA breaks result. Daunorubicin hydrochloride may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA.

Indications

INDICATIONS AND USAGE Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Principles In order to eradicate the leukemic cells and induce a complete remission, a profound suppression of the bone marrow is usually required. Evaluation of both the peripheral blood and bone marrow is mandatory in the formulation of appropriate treatment plans. It is recommended that the dosage of daunorubicin hydrochloride be reduced in instances of hepatic or renal impairment.

Contraindications

CONTRAINDICATIONS Daunorubicin hydrochloride is contraindicated in patients who have shown a hypersensitivity to it.

Warnings and precautions

WARNINGS Bone Marrow Daunorubicin hydrochloride is a potent bone marrow suppressant. Suppression will occur in all patients given a therapeutic dose of this drug. Therapy with daunorubicin hydrochloride should not be started in patients with preexisting drug-induced bone marrow suppression unless the benefit from such treatment warrants the risk. Persistent, severe myelosuppression may result in superinfection or hemorrhage. Cardiac Effects Special attention must be given to the potential cardiac toxicity of daunorubicin hydrochloride, particularly in infants and children.

Pregnancy

Pregnancy Daunorubicin hydrochloride may cause fetal harm when administered to a pregnant woman. An increased incidence of fetal abnormalities (parieto-occipital cranioschisis, umbilical hernias, or rachischisis) and abortions was reported in rabbits at doses of 0.05 mg/kg/day or approximately 1/100th of the highest recommended human dose on a body…

Storage and supply

Storage and Handling Store unopened vials in refrigerator, 2° to 8°C (36° to 46°F). Store prepared solution for infusion at room temperature, 20° to 25°C (68° to 77°F) for up to 24 hours. Contains no preservative. Discard unused portion. Protect from light. Retain in carton until time of use.

Source: Daunorubicin Hydrochloride (Daunorubicin Hydrochloride) — US FDA prescribing information, 2025-05-21, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.