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Apixaban

Hazard 3 P 3 B 0 T 0 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T comes from assessment report. Risk comes from Fass.se.

Assessment report

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:

PEC = 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

Fass environmental information

Fass environmental information for Eliquis (apixaban) (downloaded 2019-10-14).

Hazard

Persistence: "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 2017. PEC/PNEC = 0.000117 which gives the risk insignificant.

Author: The Pharmaceutical unit of Region Stockholm