In the Summary of Product Characteristics BeneFIX (nonakog alfa): BeneFIX contains recombinant coagulation factor IX, (INN = nonacog alfa). Nonacog alfa is a purified protein that has 415 amino acids in a single chain.
Fass environmental information for BeneFIX (nonacog alfa) from Pfizer (downloaded 2019-08-20).
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
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 proteins, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.
Even though biomolecules, such as vaccines and hormones, are exempted they should still be regarded as
Author: Health and Medical Care Administration, Region Stockholm