Miljöpåverkan
Amivantamab
Miljörisk:
Användning av amivantamab har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning:
Det kan inte uteslutas att amivantamab är persistent, då data saknas.
Bioackumulering:
Det kan inte uteslutas att amivantamab kan bioackumuleras, då data saknas.
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Detaljerad miljöinformation
Environmental Risk Classification
Predicted Environmental Concentration (PEC)
PEC is calculated according to the following formula:
PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.37*10-6*A*(100-R)
PEC = 0.00000498 μg/L
Where:
A = 0.0364 kg (total sold amount API in Sweden year 2022, based on calculations [average of substance to be sold coming 3 years])
R = X % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.
P = number of inhabitants in Sweden = 10 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. I)
D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Ref. I)
According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines, and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.
Amivantamab, a monoclonal antibody, can be categorized as a protein and is therefore exempted from the ERA-guideline.
It can be concluded that it is unlikely that the use of amivantamab results in significant risk to the environment.
Conclusion: Use of amino acids/peptides/proteins has been considered to result in insignificant environmental impact.
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Not available.
Other ecotoxicity data:
Not available.
Environmental risk classification (PEC/PNEC ratio)
Not available.
Degradation
Biotic degradation
Not available
The potential for persistence cannot be excluded due to lack of data.
Abiotic degradation
Not available
Bioaccumulation
Not available
The potential for bioaccumulation of Amivantamab cannot be excluded, due to lack of data.
Excretion (metabolism)
Not available
PBT/vPvB assessment
Amivantamab does not fulfils the criteria for PBT and/or vBvP.
References
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_
requirements_en.htm