Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
Daunorubicin is an anthracycline glycoside antibiotic and is a potent antileukaemic agent. It also has immunosuppressant effects.
The exact mechanism of antineoplastic action is uncertain but may involve binding to DNA by intercalation between base pairs and inhibition of DNA and RNA synthesis by template disordering and steric obstruction. Daunorubicin is most active in the S-phase of cell division but is not cycle phase specific. Tumour cell cross-resistance has been observed between daunorubicin and doxorubicin.
No controlled paediatric studies have been conducted.
The literature mentions the use of daunorubicin in treatment regimens for ALL and AML, including paediatric age groups. However, due to the ongoing search for a balance in gain or maintenance of efficacy and a decrease in toxicity the use of daunorubicin in the treatment of paediatric ALL and AML is fluctuating in clinical practice, mainly depending on risk stratification and specific subgroups. Published studies suggest no differences in safety profile between paediatric patients and adults.
Daunorubicin is rapidly taken up by tissues, especially by the kidneys, spleen, liver and heart. It does not cross the blood-brain barrier, subsequent release of drug and its metabolites from the tissues is slow (t½=55 hours). Daunorubicin is rapidly metabolised in the liver. The major metabolite daunorubicinol is also active. Daunorubicin is excreted slowly in the urine, mainly as metabolites with 25% excreted in the first 5 days. Biliary excretion also makes a significant (40%) contribution to elimination.
No further information available.
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