Aripiprazole lauroxil is a dodecanoate ester and a prodrug for aripiprazole. Aripiprazole lauroxil is a long-acting injectable atypical antipsychotic drug used in the treatment of schizophrenia in adult patients. Aristada® was initially approved by the Food and Drug Administration (FDA) in October 2015. It is administered via intramuscular (IM) injection and requires the establishment of tolerability prior to dosing in treatment-naïve patients. In July 2018, a different formulation of aripiprazole lauroxil, marketed as Aristada Initio®, was FDA-approved for immediate initiation of Aristada® at any dose. Patients may receive Aristada Initio® in combination with a single 30 mg oral dose of aripiprazole to achieve appropriate levels of aripiprazole more rapidly. Long-acting injectable aripiprazole lauroxil displayed comparable efficacy and safety to aripiprazole, and reduced dosing frequency improves patient adherence.
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 Aripiprazole Lauroxil, 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.