Daunorubicin
Summary
Persistence. It cannot be excluded that daunorubicin is persistent, due to no data available.
Bioaccumulation. Daunorubicin has low potential for bioaccumulation.
Toxicity. It cannot be excluded that daunorubicin is toxic, due to no data available.
Risk. Daunorubicin is not considered an environmental risk according to the environmental risk assessment (Phase I environmental study) in the public assessment report. However, risk of environmental impact of daunorubicin cannot be excluded, since no ecotoxicity data are available.
This summary information comes from fass.se and assessment reports.
Detailed information
Assessment report Vyxeos
Assessment report for Vyxeos (daunorubicin, cytarabine) om daunorubicin, 28 June 2018, EMA/486480/2018.
"For daunorubicin, the experimental value of log P reported in the literature is 1.83 (EPA, 2017), compared with the estimated value of 1.79. The experimental log P values for the drug substances cytarabine, -2.02, and daunorubicin, 1.83, are below 4.5; therefore, further screening is not necessary for persistence, bioaccumulation, and toxicity. Calculation of the Predicted Environmental Concentration. The PECSURFACEWATER value is not above 0.01 µg/L for both drug substances, therefore, the phase II environmental-fate and effect analysis is not required."
Assessment report Vyxeos, typ II-variation
Assessment report for Vyxeos, typ II variation, 24 March 2022, EMA/665588/2022.
The same as above for bioaccumulation."Total PECsurfacewater PECSW Daunorubicin = PECSW for adults + PECSWr for children and adolescents + PECSWr for other use. PECSW Daunorubicin = 0.000090 μg/L + 0.00000039 μg/L + 0.0000006 μg/L = 0.000091 μg/L. Therefore, the PECSW for either drug substances are below the action limit threshold of 0.01 μg/L and a Phase II environmental-fate and effect analysis is not required."
Comment
Daunorubicin has only undergone a phase I study in accordance with regulatory requirements for environmental risk assessments (Guideline on the environmental risk assessment of medicinal products for human use, EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.) A phase I study includes data on bioaccumulation and an estimation of the environmental concentration of daunorubicin (PECSurface water). If the specified threshold values are not exceeded, the company is not required to conduct a Phase II study, which includes data on toxicity, persistence, and risk assessment based on PEC/PNEC.
Fass environmental information
Fass environmental information for Cerubin (daunorubicin) from Sanofi AB (accessed on 2025-05-15).
Hazard
Persistence: No data available.
Bioaccumulation: log P = 1.83 at neutral (experimentally determined with unknown method).
Toxicity: No data available.
Risk
Risk of environmental impact of daunorubicin cannot be excluded, since there is no data to calculate a PEC/PNEC ratio.
References
- European Medicines Agency. European public assessment report (EPAR) for Vyxeos (daunorubicin, cytarabine) om daunorubicin, 28 June 2018, EMA/486480/2018.
- European Medicines Agency. European public assessment report (EPAR) for Vyxeos, typ II variation, 24 March 2022, EMA/665588/2022.
- Fass för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm