Bortezomib

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, not all medicinal products containing the same active substance.

Assessment report for Velcade 2013

Assessment report for Velcade (bortezomib), London, 27 June 2013
EMA/416707/2013.

Hazard

Persistence: No data.

Bioaccumulation: Log P_ow of bortezomib is 2 (pH=7).

Toxicity: No data.

Risk

"The worst case surface water Predicted Environmental Concentration (PEC_surfacewater) for bortezomib, assuming no degradation or removal in sewage sludge treatment, is 0.32 µg/L. After refinement with market penetration data, for which the Applicant calculated that, approximately 19'500–20'000 patients will receive bortezomib as treatment for their disease and estimated that the consumption for all bortezomib treated patients in EU in the peak year 2016 will be approximately 1.92 kg/year and 5252 mg/day, the PEC_surfacewater was calculated to be 0.0052 x 10^-3 µg/L. As the PEC_surfacewater of bortezomib is in orders of magnitude below the threshold value of 0.01 µg/L, no further testing in the aquatic environment (phase II) is required."

Assessment report for Velcade 2014

Assessment report for Velcade, 18 December 2014, EMA/74029/2015 adopted.

"In conclusion no significant increase in environmental exposure is anticipated based on this extension of indication."

Other assessment reports with bortezomib

Assessment report for Bortezomib Fresenius Kabi (19 September 2019, EMA/CHMP/552819/2019), Bortezomib Hospira (26 May 2016, EMA/CHMP/421198/2016), Bortezomib Accord (21 May 2015, EMA/449381/2015), Bortezomib SUN (26 May 2016, EMA/CHMP/449636/2016). Similar information in all. The below is from Bortezomib Fresenius Kabi.

"No Environmental Risk Assessment studies were submitted. This was justified by the applicant as the introduction of Bortezomib Fresenius Kabi manufactured by Fresenius Kabi Deutschland GmbH is considered unlikely to result in any significant increase in the combined sales volumes for all bortezomib containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar."

Fass environmental information

Fass environmental information for Velcade from Janssen (downloaded 2024-07-04).

Hazard

Persistence: Not data.

Bioaccumulation: Log K_ow = 2.8 using unknown internal method. According to ChemSpider ACD/Percepta the log K_ow = 2.45. According to ChemSpider ACD/BCF (pH7.4) = 15.60.

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) NOEC 450 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2022. PEC/PNEC = 0.00004981 which gives the risk insignificant.