Fosaprepitant

Detailed information

Fass environmental information

Fass environmental information for Ivemend (fosaprepitant) from MSD (retrieved on 2025-07-01).

Hazard

Persistence: Biotic degradation: In a sludge biodegradation test (OECD 314), fosaprepitant showed 50% degradation over 66 days based on CO₂ evolution, indicating it is not readily biodegradable. Therefore, the phrase “Fosaprepitant is potentially persistent” is considered justified.

Bioaccumulation: Bioconcentration Factor (BCF), bluegill sunfish, (Lepomis macrochirus) (OECD 305) Steady state BCF (whole fish) range: 39.2–47.9.

Toxicity: There are data for 3 trophic levels, most sensitive crustacean NOEC 18 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2022. PEC/PNEC = 0.000015 which gives the risk insignificant.

Assessment report Ivemend 2008

Assessment report for Ivemend, EMEA/42754/2008.

"In the environmental risk evaluation, the PEC value calculated for the EU is below 0.01 µg/l."

Assessment report Ivemend 2010

Assessment report for Ivemend for Ivemend, London, 24 June 2010, EMA/559664/2010.

The applicant has addressed the initial question, but a second has been raised and is proposed as a follow-up measure. An updated environmental risk assessment (ERA) for Ivemend supports the use of aprepitant, as fosaprepitant is a prodrug. A reported log K_ow of 4.8 exceeds the action limit, but validation is pending. Two PEC_surfacewater calculation methods were submitted—only one is partially acceptable. As the PEC value exceeds the trigger, a Phase II assessment is required. Provided aquatic effect data are insufficient and must be supplemented with validated studies. No such data were found in the search conducted on the EMA website (as of 1 July 2025).