CERUBIDINE

SANOFI
Identification
- Active ingredient (INN)
- DAUNORUBICINE CHLORHYDRATE EXPRIME EN DAUNORUBICINE
- Internal code
- 05 G 014
- Country of Origin
- France
- Pharmaceutical form
- Powder for IV Perfusion Sol.
- Prescription List
- Highly Regulated (List I)
- Packaging
- b/10fl.

DAWA Clinical Workbench v2.0
Information may not be accurate. Always consult a physician, pharmacist, or specialist before acting on any data shown here.
Description
A very toxic anthracycline aminoglycoside antineoplastic isolated from Streptomyces peucetius and others, used in treatment of leukemia and other neoplasms.
Indications
For remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
Daunorubicin is indicated in combination with cytarabine for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.
Pharmacodynamics
Daunorubicin is an anthracycline antibiotic and antineoplastic agent.
It acts by inhibiting cellular reproduction through interference with DNA replication although it may contribute to the induction of cell death by increasing oxidative stress through the generation of reactive oxygen species and free radicals.
As an antineoplastic agent, daunorubicin carries significant toxicities including cytopenias, hepatotoxicity, and extravasation reactions.
Like other anthracyclines, daunorubicin also exhibits cardiotoxicity in proportion with the cumulative dose received over time.
Mechanism of Action
DNA topoisomerase 2-alpha Inhibitor DNA topoisomerase 2-beta Inhibitor.
Absorption
Daunorubicin was found to have a tmax of 2 h and a cmax of 24.8 μg/mL after a 90 min infusion of the liposomal formulation at a dose of 44 mg/m 2.
Volume of Distribution
Daunorubicin has a steady-state volume of distribution of 1.91 L/m 2 reported with the liposomal formulation.
The average volume of distribution reported for the liposomal formulation is 6.6 L.
Metabolism
Hover over products below to view reaction partners Daunorubicin Daunorubicinol Deoxydaunorubicinol aglycone Deoxydaunorubicinol aglycone Deoxydaunorubicinol aglycone-13-O-β-glucuronide Demethyl deoxydaunorubicinol aglycone Demethyl deoxydaunorubicinol aglycone-4-O-β-glucuronide Demethyl deoxydaunorubicinol aglycone-4-O-sulfate Daunorubicinol aglycone Deoxydaunorubicin aglycone Deoxydaunorubicinol aglycone Demethyl deoxydaunorubicinol aglycone Demethyl deoxydaunorubicinol aglycone-4-O-β-glucuronide Demethyl deoxydaunorubicinol aglycone-4-O-sulfate Deoxydaunorubicinol aglycone-13-O-β-glucuronide.
Route of Elimination
Daunorubicin is eliminated hepatically. 40% of daunorubicin is excreted in the bile while 25% is excreted in an active form (daunorubicin or daunorubicinol) in the urine.
In the liposomal formulation, only 9% of active molecules are excreted in the urine.
Half-life
Daunorubicin has been determined to have a terminal half-life of 18.5 h (+/ - 4.9).
Daunorubicinol, the primary active metabolite has been determined to have a terminal half-life of 26.7 h (+/ - 12.8).
The mean half-life of elimination of liposomal daunorubicin has been reported to be 22.1 h in pharmacokinetic studies and 31.5 h in official FDA labeling. 3, 5.
Clearance
Daunorubicin has a clearance of 68.4 mL/h/m 2 determined using the liposomal formulation.
Adverse Effects
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