Dasatinib

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: DT_{50, 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 PEC_sw 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 K_ow 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.