Please note, this OEL/ADE monograph also applies to Tegafur sodium (CAS RN 28721-46-2). Tegafur is an antineoplastic agent used in combination with other anticancer medications to treat advanced gastric and colorectal cancers such as malignant neoplasms including those of the breast, gallbladder, gastrointestinal tract, head and neck, liver, and pancreasl, exerting activity after conversion to 5- fluorouracil in the liver. Tegafur is a prodrug of fluorouracil (5-FU), an antineoplastic agent used in the treatment of various cancers such as advanced gastric and colorectal cancers. It is usually given in combination with other drugs that enhance the bioavailability of the 5-FU by blocking the enzyme responsible for its degradation or serves to limit the toxicity of 5-FU by ensuring high concentrations of 5-FU at a lower dose of tegafur. When converted and bioactivated to 5-FU, the drug mediates an anticancer activity by inhibiting thymidylate synthase (TS) during the pyrimidine pathway involved in deoxyribonucleic acid (DNA) synthesis.
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), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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