Repaglinide

Detailed information

Fass environmental information

Fass environmental information for NovoNorm (repaglinide) from Novo Nordisk (downloaded 2022-03-21).

Hazard

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 D_ow for Repaglinide is 2.5."

Toxicity: There is data for 1 trophic level, NOEC crusteans (Daphnia Magna) 34000 microg/L.

Risk

"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.