Miljöpåverkan
Erenumab
Miljörisk:
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
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Detaljerad miljöinformation
Detailed background information
According to the European Medicines Agency (EMA) guideline for Environmental Risk Assessment of pharmaceuticals (EMEA/CHMP/SWP/4447/00 corr 2), an ERA consisting of a justification for not submitting ERA studies is sufficient for certain active pharmaceutical ingredients:
“In the case of products containing vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids as active pharmaceutical ingredient(s), an ERA should be provided. This ERA may consist of a justification for not submitting ERA studies, e.g. due to their nature they are unlikely to result in a significant risk to the environment. The same applies to vaccines and herbal medicinal products.”
Erenumab, the active ingredient of Aimovig, is a human IgG2 monoclonal antibody that is directed against the calcitonin gene-related peptide (CGRP) receptor. In addition to the active ingredient, erenumab, the medicinal product contains the following excipients, which are either naturally occurring substances or have been shown to have no significant impact on the environment: sucrose, glacial acetic acid, polysorbate 80 and sodium hydroxide.
It can be expected that erenumab after application to the patient by subcutaneous injection is completely metabolized and adsorbed in the body. Any medicinal product that reaches water streams via eventual spills during application or after disposal of unused drug is expected to be very rapidly degraded and mineralized to CO2 by microbial activity. It is therefore expected that erenumab constitutes no risk to the environment.
References
EMEA/CHMP/SWP/4447/00 corr 2. Guideline on the environmental risk assessment of medicinal products for human use. London, 01 June 2006.