Finerenone

Detailed information

Assessment report

Assessment report for Kerendia (finerenone), Bayer AG, 16 December 2021, EMA/78746/2022.

Hazard

Persistence: "The dissipation half-life from water was determined with 78.9 and 147.9 days for sediment 1 and 2, respectively. The degradation half-life in sediment (= whole system degradation half-life) was 80.05 and 191.7 days for sediment 1 and 2, respectively. Based on the data, finerenone has to be classified as very persistent (vP). [---] Distribution studies showed that finerenone is primarily distributed to the sediment compartment, and not degraded. Based on the data, finerenone has to be classified as very persistent (vP) in sediment. One major transformation product (M-1) was detected which increased over time and accounted for more than 90 %AR at the end of the study. This indicates that M-1 is also persistent."

Bioaccumulation: Log K_ow 2.61 at pH 7 (OECD107).

Chronic toxicity: There are data for 3 trophic levels, most sensitive fish (fathead minnow) NOEC 0.01 microg/L.

Risk

"Fish (fathead minnow) was the most sensitive species for finerenone aquatic effects, with a NOEC of 0.00001 mg/L (0.01 μg/L). RQ-values (based on unrefined and refined PEC_sw values) show that finerenone poses a risk to the surface-water compartment but not the ground water."

"Based on toxicity criteria for PBT assessments, finerenone is considered toxic for both fish and daphnia (NOEC< 10 μg/L). Fish (fathead minnow) was the most sensitive species for finerenone aquatic effects, with a NOEC of 0.00001 mg/L (0.01 μg/L) but based on refined (SimpleTreat) PEC values, the RQ is < 1. Based on sediment-dweller toxicity (OC10% NOEC ~46.1 mg/kg dw) and refined sediment PEC (0.12 mg/kg dw), there was also no indication of environmental risk to sediment-dwellers (RQ < 1)."

"Thus, collectively finerenone persistence and exposure at the proposed dosing may pose a risk to the aquatic and sediment organisms. Therefore, finerenone should be used according to the precautions stated in the SmPC (red. anm. produktresumén, Summary of Product Characteristics, SmPC) and in order to minimize any potential risks to the environment, appropriate labelling should be included in the SmPC and product label documents." No information about the environment is found in the SmPC for Kerendia. The following is written in the package leaflet: "Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment." According to the Swedish Medical Products Agency (2023-11-03) the information about precautions in the assessment report has been wrongly included. The risk ratios are < 1 for all parts. Although finerenone is toxic (T) and persistent (vP), the substance is neither PBT nor vPvB. When a risk has been identified (RQ > 1) or if the substance is PBT or vPvB, this should be included in the SmPC. That is (and was) not the case. It may be added that a variation application was more recently approved for Kerendia (EMA/41550/2023). Also in this, the conclusion was drawn that the risk ratios fall below 1, which is why there is no environmental risk to address in the SmPC for Kerendia. The Swedish Medical Products Agency will now contact EMA and propose a revision of this part of Kerendia's assessment report.

Fass environmental information

Fass environmental information for Kerendia from Bayer (downloaded 2024-04-12).

Hazard

Persistence: "Substance finerenone shows DT₅₀ up to 191.7 days and is resistant to hydrolysis. The phrase “Finerenone is potentially persistent” was chosen."

Bioaccumulation: Log K_ow = 2.61 at pH 7 (guideline OECD 107).

Chronic toxicity: There are data for 3 trophic levels, most sensitive fish (Pimephales promelas) NOEC 0.01 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2022. PEC/PNEC = 0.0000256 which gives the risk insignificant.