Persistence. Repaglinide is potentially persistent.
Bioaccumulation. Repaglinide has low potential for bioaccumulation.
Toxicity. Repaglinide has low chronic toxicity. However, there is only data for one trophic level.
Risk. Risk of environmental impact cannot be excluded, since there is not sufficient ecotoxicity data available.
This summary information comes from Fass.se.
Fass environmental information
Fass environmental information for NovoNorm (repaglinide) from Novo Nordisk (downloaded 2022-03-21).
Persistence:"Ready biodegradability: Test results in 16 % degradation in 28 days (US-FDA, Tech. Assist. Doc. 3.11.) [...] Since only 16% was degraded in the biodegradation test, Repaglinide is thus not readily biodegradable. It cannot be excluded that Repaglinide is potentially persistent in the aquatic environment according to ref. 1."
Bioaccumulation: "The highest estimated Log Dow for Repaglinide is 2.5."
Toxicity: There is data for 1 trophic level, NOEC crusteans (Daphnia Magna) 34000 microg/L.
"Since eco-toxicological data is only available for one trophic level (daphnia) a valid risk quotient (PEC/PNEC) cannot be calculated according to ref. 1."
It is voluntary for manufacturers to provide information about environmental impact on fass.se.
Assessment reports for generics
There are assessment reports for generics with similar information. Presented here what is in the assessment report for Repaglinide Accord (repaglinide), Accord Healthcare Limited, October 2011, EMA/9712/2012.
"No Environmental Risk Assessment was submitted. This was justified by the applicant as the introduction of Repaglinide Accord manufactured by Intas Pharmaceuticals Limited and Accord Healthcare Limited is considered unlikely to result in any significant increase in the combined sales volumes for all repaglinide containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar and not increased."
Comparison with glibenclamide
Report from Joakim Larsson/Goodpoint about environmental risk assessments of possible substitute substances for substances on Region Stockholm's list of environmentally harmful drug substances 2017–2021.
Glibenclamide is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental program 2017–2021, mainly based on the presence of glibenclamide in wild fish at concentrations close to therapeutic concentrations in humans. It is also reasonable based on the fact that glibenclamide has a high potential for bioaccumulation and concentrations found in Swedish wastewater. Relevant effect studies are still lacking, which makes it difficult to specify the risk. The risk of repaglinide accumulating in fish close to therapeutic concentration is significantly lower, although sales increase sharply. It is therefore justified from an environmental risk perspective to replace glibenclamide with repaglinide.
- Fass.se för vårdpersonal.
- European Medicines Agency. European public assessment report (EPAR). Repaglinide Accord Accord Healthcare Limited, October 2011, EMA/9712/2012.
- Region Stockholm. Förteckning över miljöbelastande läkemedel inklusive åtgärdsförslag framtagen inom ramen för SLL:s miljöprogram 2017–2021.
- Thomsen MS, Chassard D, Evène E, Nielsen KK, Jørgensen M. Pharmacokinetics of repaglinide in healthy caucasian and Japanese subjects. J Clin Pharmacol. 2003;43:23-8.
- Fitzsimmons PN, Fernandez JD, Hoffman AD, Butterworth BC, Nichols JW. Branchial elimination of superhydrophobic organic compounds by rainbow trout (Oncorhynchus mykiss). Aquat Toxicol. 2001;55:23-34.
- Provtagningar av läkemedelsrester i vatten, sediment och fisk för Region Stockholm.
- Jämförande miljöriskbedömningar av möjliga ersättningssubstanser för substanser på Stockholms läns landstings förteckning över miljöbelastande läkemedelssubstanser 2017–2021.
Author: Health and Medical Care Administration, Region Stockholm