Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Sorafenib

Hazard 9 P 3 B 3 T 3 Risk See below

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T comes from assessment report, see below. "The compound is considered as vP and vB."

Assessment report

Assessment report for assessment report for Nexavar (sorafenib) 25 April 2014 EMA/CHMP/220738/2014.

Hazard

Persistence: "There was no degradation after 28 days. DT50 (transformation in soil) - 187 days." Conclusion: vP.

Bioaccumulation: BCF = 7 250 "ratio fish/water concentration at the end of exposure." Conclusion: vB.

Chronic toxicity: There is NOEC /EC10 for 3 trophic levels, lowest NOEC /EC10 for fish 0,17 microg/L.

"The compound is considered as vP and vB."

Risk

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

PEC = 0.0378 microg/L

PNEC = Lowest NOEC/EC10: 0.17 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.017 mikrog/L

PEC/PNEC = 2.224

Fass environmental information

Fass environmental information for Nexavar (sorafenib) (downloaded 2018-06-27).

Hazard

Persistence: "Sorafenib showed no degradation in a water-sediment system (OECD 308). Sorafenib is potentially persistent."

Bioaccumulation: "The BCFs was determined with 5300 for the higher concentration and >7300 for the lower concentration, where no steady-state was reached."

Chronic toxicity: here is NOEC /EC10 for 3 trophic levels, lowest NOEC /EC10 (EC10/28d; mortality) for fish 0.17 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.2 which gives the environmental risk low. As stated above: "The compound is considered as vP and vB."

Author: Health and Medical Care Administration, Region Stockholm