Nevirapine
Summary
Persistence. Nevirapine is potentially persistent.
Bioaccumulation. Nevirapine has low potential for bioaccumulation.
Toxicity. Nevirapine has moderate acute toxicity.
Risk. The use of nevirapine (sales data Sweden 2022) has been considered to result in insignificant environmental risk.
This summary information comes from fass.se.
Detailed information
Fass environmental information
Fass environmental information for Viramune (nevirapine) from Boehringer Ingelheim AB (retrieved on 2026-01-09).
Excretion (metabolism)
Only a small fraction of the administered nevirapine dose is excreted unchanged. In a human metabolism study, about 81% of the dose was excreted in urine as metabolites, mainly glucuronide conjugates of hydroxylated metabolites. The pharmacological activity of these metabolites is unknown.
The environmental information on fass.se pertains to nevirapine.
Hazard
Persistence: Nevirapine showed only 7% degradation in a 28‑day test and is therefore not considered readily biodegradable. No data are available on inherent biodegradability or simulation studies. It is stable at pH 5–9 and relatively stable under light. It shows low adsorption to soil and sludge and is highly mobile (log Koc 1.0–2.5). Overall, nevirapine is considered “potentially persistent”.
Bioaccumulation: Log Pow = 1.81 at pH 4.9. BCF of 4.9.
Toxicity: There are data for 3 trophic levels, most sensitive algae EC50 > 43 mg/L. Comment: Values reported as greater than are not according to the guidelines. The actual value may be lower.
Risk
PEC/PNEC is based on sales data in Sweden in year 2022.
PEC = 0.00335 microg/L.
PNEC = Lowest EC50, 43000 mikrog/L/1000 (Assessment Factor (AF) for 3 acute studies) = 43 microg/L.
PEC/PNEC = 0.00008 which gives the risk insignificant.
EMA’s scientific discussion
EMA’s scientific discussion for Viramune, 2005-10-21.
"Environmental risk assessment did not foresee any toxicological risk for the environment with nevirapine."
Assessment report
Assessment report for Viramune for a new pharmaceutical form, 21 July 2011, EMA/538380/2011.
"The market introduction of this new pharmaceutical form, Viramune prolonged-release tablets, developed to offer long-term treated HIV-1 patients a once-a-day formulation for their convenience, without a proposal for new indications and without a change in total daily dose, will not result in a significant increase of environmental exposure to the drug substance, nevirapine and thus an updated ERA is not necessary as part of the application."
Author: Health and Medical Care Administration, Region Stockholm