Dasatinib
Summary
Persistence. Dasatinib is slowly degraded in the environment.
Bioaccumulation. Dasatinib has low potential for bioaccumulation.
Toxicity. Dasatinib has high chronic toxicity.
Risk. The use of dasatinib (sales data Sweden 2021) has been considered to result in insignificant environmental risk.
This summary information about properties comes from fass.se and the assessment report. The risk comes from fass.se.
Detailed information
General information about assessment reports
Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.
The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, as well as possibly other products from the same company, not all medicinal products containing the same active substance.
Assessment report Sprycel
Assessment report for Sprycel (dasatinib) 26 April 2018, EMA/CHMP/302652/2018.
Hazard
Persistence: "Dasatinib was not readily biodegradable at 28 days. OECD 308: DT50, whole system =79.7–131 days % shifting to sediment = 27.1-56.3."
Bioaccumulation OECD 107: pH 5 – 1.85, pH 7,8 – 3.56, pH 9 - 3.56. Conclusion: not B.
Chronic toxicity: There are data for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 18 microg/L.
Risk
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PEC = 1.8 microg/L
PNEC = Lowest NOEC, 18 microg/L/10 (Assessment Factor (AF) for 3 chronic studies = 1.8 microg/L
PEC/PNEC = 1, which gives the risk low.
Assessment report Sprycel, typ II variation
Assessment report for Sprycel 13 December 2018, EMA/CHMP/3851/2019, typ II-variation.
"No ERA studies were submitted (see discussion on non-clinical aspects).The justification provided by the MAH for not performing environmental risk assessment studies was considered acceptable. The addition of the paediatric population to the currently approved indications is not expected to significantly increase the use of dasatinib on the EU market. Therefore, it is unlikely that dasatinib will pose a significant risk to the environment."
Assessment report Dasatinib Accord Healthcare
Assessment report for Dasatinib Accord Healthcare 30 May 2024, EMA/313181/2024.
"The submitted environmental risk assessment consisted of a Phase I exposure assessment. Since the refined PECsw value was below 0.01 μg/L, and no other environmental concerns were apparent, it is concluded that the medicinal product Dasatinib Accord Healthcare 20, 50, 70, 80, 100, and 140 mg filmcoated tablets is unlikely to present a risk for the environment following its prescribed usage in patients."
Fass environmental information
Fass environmental information for Sprycel (accessed on 2025-05-15).
Hazard
Persistence OECD 308: "The total system half-life of dasatinib (based on dissipation rates) for sediments 1 and 2 was 79.7 and 131 days, respectively."
Bioaccumulation: "Log Kow values of 1.85 at pH 5, 3.56 at pH 7.8 and 3.56 at pH 9."
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 18 microg/L.
Risk
PEC/PNEC is based on sales data in Sweden in year 2021. PEC/PNEC = 0.0000001 which gives the risk insignificant.
References
- European Medicines Agency. European public assessment reports (EPAR) for Sprycel (dasatinib) 26 April 2018, EMA/CHMP/302652/2018.
- European Medicines Agency. European public assessment reports (EPAR) for Sprycel 13 December 2018, EMA/CHMP/3851/2019, typ II-variation.
- European Medicines Agency. European public assessment reports (EPAR) for Dasatinib Accord Healthcare 30 May 2024, EMA/313181/2024.
- Fass.se för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm