Nitisinone is indicated for the treatment of tyrosinemia, an error of metabolism, usually inborn, in which the body cannot effectively break down the amino acid tyrosine. Nitisinone prevents accumulation of maleylacetoacetate and fumarylacetoacetate in patients with hereditary tyrosinemia type 1 by inhibiting 4-hydroxyphenyl-pyruvate dioxygenase, which is an enzyme in the tyrosine catabolic pathway. Maleylacetoacetate and fumarylacetoacetate are catabolic intermediates that are converted to liver- and kidney-toxic metabolites, succinylacetone and succinylacetoacetate. Succinylacetone also plays a role in causing porphyric crises via inhibition of the porphyrin synthesis pathway.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.