Please note, this OEL/ADE monograph also applies to alterante CAS RN 58-05-9, levoleucovorin disodium (CAS RN 1141892-29-6), and levoleucovorin calcium (CAS RN 80433-71-2). Levoleucovorin (l-leucovorin) is the enantiomerically active form of folinic acid (also known as 5-formyl tetrahydrofolic acid or leucovorin). Commercially available leucovorin is composed of a 1 to 1 racemic mixture of the dextrorotary and levorotary isomers, while levoleucovorin contains only the pharmacologically active levo-isomer. As a folate analog, levoleucovorin and leucovorin are both used to counteract the toxic effects of folic acid antagonists, such as methotrexate. It is indicated for use as rescue therapy following the use of high-dose methotrexate in the treatment of osteosarcoma or for diminishing the toxicity associated with inadvertent overdosage of folic acid antagonists. Levoleucovorin has an additional indication for use in combination chemotherapy with 5- fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
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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