Please note, this OEL/ADE monograph also applies to bictegravir sodium (CAS RN 1807988-02-8). Bictegravir is indicated in the management of HIV-1 infection in patients who have no antiretroviral treatment history. It is a component of a complete regimen (in combination with tenofovir and emtricitabine) for the treatment of of HIV-1 infection in patients who are virologically suppressed (HIV-1 RNA <50 copies/mL). Patients should be on a stable antiretroviral regimen for a minimum of 3 months without a history of failure in treatment and no known factors associated with the resistance to the individual components of the medication.
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:
To order an OEL monograph for this compound, just click the ADD TO CART button.
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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.