Please note, this OEL/ADE monograph also applies to Tirabrutinib hydrochl. Tirabrutinib is an orally administered, small molecule, Bruton's tyrosine kinase (BTK) inhibitor. It was first approved in Japan for the treatment of recurrent or refractory primary central nervous system lymphoma (PCNSL) and later received a supplemental approval for Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma. Tirabrutinib has also been approved in other Asian countries including South Korea and Taiwan. Clinical development is underway in the United States, Europe and Japan for treatment of autoimmune disorders, chronic lymphocytic leukemia, B cell lymphoma, Sjogren's syndrome, pemphigus and rheumatoid arthritis.
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:
To order an OEL/ADE monograph for Tirabrutinib, just click the ADD TO CART button.
If you're wondering about HBEL, we have something for you.
Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
Affygility Solutions’ 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.