Ibrutinib is an orally bioavailable, small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Ibrutinib acquired an accelerated approval for the treatment of mantle cell lymphoma (for patients who have received at least one prior therapy). Mantle cell lymphoma (MCL) is a Bcell non-Hodgkin lymphoma that develops in the outer edge of a lymph node. Mantle cell lymphoma (MCL) is usually diagnosed at late stages, and it is easily spread into bone marrow, spleen, liver and the gastrointestinal (GI) tract Ibrutinib is indicated for the treatment of chronic lymphocytic leukemia (CLL) (for patients who have received at least one prior therapy). Chronic lymphocytic leukemia (CLL) is a type of cancer caused by an overproduction of lymphocytes by the bone marrow. Some of the symptoms include swollen lymph nodes and tiredness. Other indications are described in the monograph.
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 Ibrutinib, just click the ADD TO CART button.
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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.