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Cytarabine

Summary

Persistence. It cannot be excluded that cytarabine is persistent, due to the lack of data.

Bioaccumulation. Cytarabine has low potential for bioaccumulation.

Toxicity. It cannot be excluded that cytarabine is toxic, due to the lack of data.

Risk. Risk of environmental impact of cytarabine cannot be excluded, due to the lack of environmental toxicity data.

 

The bioaccumulation information about cytarabine comes from the Vyxeos liposomal (cytarabine, daunorubicin) assessment report. Environmental information is missing on fass.se for cytarabine (2024-12-10).

Detailed information

Assessment report

Assessment report for Vyxeos liposomal (cytarabin, daunorubicin) about cytarabin "Type II group of variations", 24 March 2022, EMA/665588/2022.

Hazard

Persistence: No data.

Bioaccumulation: "The log Kow of cytarabine at 21°C, determined for 3 different water:octanol ratios from 0.5 to 2 using the shake flask method, was determined to be -2.02 ± 0.04. ... The experimental log Kow values for the drug substances cytarabine and daunorubicin are below 4.5; therefore, further screening is not considered necessary for persistence, bioaccumulation, and toxicity."

Toxicity: No data.

Risk

"PECSW Cytarabine = PECSW for adults + PECSW for children and adolescents PECSW Cytarabine = 0.00020 μg/L + 0.00000089 μg/L = 0.00020 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

Cytarabine has only undergone a phase I study according to regulatory requirements for environmental risk assessments (European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006.) A phase I study includes data on bioaccumulation and calculates the concentration of cytarabine in the environment (PECSurface water). If specified limit values are not exceeded, the company does not need to conduct a phase II study that includes data on toxicity and persistence and calculation of risk based on PEC/PNEC.

References

  1. European Medicines Agency. European public assessment report (EPAR) for Vyxeos liposomal (cytarabin, daunorubicin) "Type II group of variations", 24 March 2022, EMA/665588/2022.

Author: Health and Medical Care Administration, Region Stockholm