OEL Fastrac Catalog

When given in combination with ivacaftor as the fixed dose combination product Orkambi®, lumacaftor is indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older, who are homozygous for the F508del mutation in the CF transmembrane conductance regulatory (CFTR) gene. Lumacaftor is a CFTR corrector (ivacaftor is a potentiator) that improves CF symptoms and underlying disease pathology by aiding the conformational stability of F508-mutated CFTR, resulting in increased processing and trafficking of mature protein to the cell surface, where it exhibits improved chloride channel function compared to uncorrected F508del-CFTR. More specifically, lumacaftor acts directly with CFTR and/or CFT-associated proteins as a proteinfolding chaperone, preventing misfolding of CFTR ion channels and consequent destruction during processing in the endoplasmic reticulum. The restoration of chloride secretion has been shown to improve mucocilliary clearance; in individuals with CF, this is expected to alleviate mucus plugging, infection, and inflammation that leads to irreversible structural changes in the lungs, and eventually respiratory failure.

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Lumacaftor, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.