Octreotide

Fass environmental information

Fass environmental information for octreotide (Octreotide Teva, Oktreotid SUN och Sandostatin) from Teva, SUN Pharmaceutical and Novartis, respectively.

Risk

The use of amino acids, proteins and peptides is not considered to have any environmental impact.

Detailed information

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 biologically active.

Novartis also has the following information: "It can be expected that any octreotide that is excreted by patients will be rapidly degraded. The assumption that octreotide has low potential to result in a significant risk to the environment due to its nature as easily degradable protein, is supported by the fact that a study on biological degradation following OECD 301B showed 76.0 to 85.0 % degradation."