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Apixaban

Information

This summary information on persistence, bioaccumulation and toxicity comes from the assessment report for Eliquis (apixaban) June 26, 2014 and Fass. The risk comes from Fass.

Persistence. Apixaban is degraded slowly in the environment.
Bioaccumulation. Apixaban has low potential for bioaccumulation.
Toxicity. Apixaban has low chronic toxicity.
Risk. The use of apixaban (sales data Sweden 2018) has been considered to result in insignificant environmental risk.

Detailed information

Assessment report for Apixaban Accord 28 May 2020, EMA/322602/2020

"No Environmental Risk Assessment studies were submitted. This was justified by the applicant as the introduction of Apixaban Accord manufactured by Accord Healthcare S.L.U. is considered unlikely to result in any significant increase in the combined sales volumes for all apixaban containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar."

Assessment report for Eliquis (apixaban) 26 June 2014, EMA/478338/2014

Hazard

Persistence: "DT50whole system = 100–182 d at 20°C." Konklusion: P.

Bioaccumulation: log Kow 1.2. Conclusion: not B.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for algae (Pseudokirchneriella subcapitata) 3 600 microg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PECsurface water = 0.175 microg/L.

PNEC = Lowest NOEC, 3 600 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 360 microg/L

PEC/PNEC = 0.000486 which gives the risk insignificant.

Fass environmental information

Fass environmental information for Eliquis (apixaban) from Bristol-Myers Squibb (downloaded 2021-06-29).

Hazard

Persistence: Ready Degradability (OECD 301B): -3.88% primary degradation over 30 days; not readily biodegradable. OECD 308: "The total system half-life of apixaban (based on dissipation rates) for sediment 1 and 2 was 100 and 182 days, respectively."

Bioaccumulation: "Log Do/w = 1.20 at approximately neutral pH at 21°C (apixaban is non-ionizable)."

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for algae (Pseudokirchneriella subcapitata) (OECD 201) NOEC 72 h (growth rate/biomass) = 3.6 mg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 0.000158 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm