Sugammadex

Detailed information

Fass environmental information

Fass environmental information for Bridion (sugammadex) from Merck Sharp & Dohme AB (retrieved on 2026-04-13).

Hazard

Persistence: In the OECD 308 study, sugammadex was tested in two different water–sediment systems. The total system half‑life ranged from 4.5 to 13.5 days, with degradation occurring mainly through transformation. Minor mineralisation was observed (5.8–8.4%), and 10–61% of the applied radioactivity consisted of bound residues at day 100. At the end of the study, 11–13% parent compound remained. One system showed no metabolites above 10%, while three such metabolites were detected in the other. As the DT₅₀ was below 32 days, the phrase "Sugammadex is degraded in the environment" is justified.

Bioaccumulation: Log K_ow = -6.4.

Toxicity: There are data for 3 trophic levels, most sensitive algae (Selenastrum capricornutum) NOEC 10000 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2022.

PEC = 0.0012 microg/L

PNEC = Lowest NOEC, 10000 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 1000 microg/L.

PEC/PNEC = 1.2E^-06 which gives the risk insignificant.

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 Bridion

Assessment report for Bridion Doc.Ref.: EMEA/CHMP/317523/2008.

"An ERA in accordance with Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00) was provided comprising of Phase I, Phase II Tier A, and Phase II Tier B consisting of a number of GLP compliant fate and effects studies. Following the response to the CHMP list of questions (LoQ), the ERA was not considered to be complete and a number of issues such as an additional Daphnia magna reproduction study (in accordance with OECD 211), elaboration of the need for an ERA for the terrestrial compartment, and an updated Phase II, Tier B ERA including an updated PEC sediment calculation needed to be addressed. As a follow-up, the applicant has committed to provide new ERA study protocols and the results, as stated in their letter of undertaking dated 28 May 2008. [...] However at present, no conclusions regarding environmental risks can be made. A number of issues remain to be addressed and the applicant has agreed to provide this information as a post-authorisation commitment, as stated in their letter of undertaking dated 28 May 2008." No requested data were found during a search of the EMA website (2026‑04‑13).

Assessment reports for sugammadex generics

There are several generics with similar environmental information in their assessment reports. Presented here is the assessment report for the most recent product, Sugammadex Piramal, dated 26 April 2023 (EMA/228402/2023).

"No environmental risk assessment (ERA) studies were submitted. This was justified by the applicant as the introduction of Sugammadex Piramal manufactured by Piramal Critical Care B.V. is considered unlikely to result in any significant increase in the combined sales volumes for all sugammadex containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be
similar."

Comment on generics

After the implementation of the latest European Medicines Agency (EMA) ERA guideline (1 September 2024), a generic company has the following options for Article 10 procedures under Directive 2001/83/EC:

i) to argue that a full ERA is not required because the pharmaceutical substance belongs to certain substance groups (e.g., so-called natural substances);

ii) to identify an official ERA from a previously accepted product and use it; or

iii) to develop its own ERA according to the latest EMA ERA guideline.

Arguments for not submitting an Environmental Risk Assessment (ERA) based on the claim that total environmental exposure has not increased (via total sales volumes) belong to the previous ERA guideline system (2006–2024) and are no longer applicable. Regarding option ii), it should be noted that if a reference ERA exists, the generic company must demonstrate that its conclusions remain technically relevant (since the latest ERA guideline introduced several new technical requirements absent in the previous ERA guideline) and in terms of exposure (showing that the estimated exposure used in the reference ERA remains reasonable). Regulatory authorities (national and EMA) recommend that generic companies attempt to obtain reference ERA documentation from other companies via a so-called Letter of Access (LoA). However, if this is not possible, it remains feasible to argue that the conclusions of an existing reference ERA are still relevant based on information gathered from public assessment reports (summarized descriptions of environmental risk assessments) and product information (to confirm that dosages, indications, etc., have not changed). It should be noted that in some cases, reference ERAs approved between 2006 and 2024 may need to be modified (e.g., with additional experimental studies). If no previous reference ERA can be identified or used, the generic company must commit to developing its own ERA.