OEL Fastrac Catalog

Tocilizumab (TCZ), also known as atlizumab, is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) IgG1 subclass with a H2L2 polypeptide structure. It is indicated in the following conditions reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis (RA), for the treatment of giant cell arteritis (GCA) in adult patients, for the treatment of signs and symptoms of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older who have responded inadequately to previous therapy with disease-modifying antirheumatic drugs (DMARDs), for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with one or more non-steroidal anti-inflammatory drugs and systemic corticosteroids, for the treatment of patients with chimeric antigen receptor (CAR) T cell induced severe or life-threatening cytokine release syndrome (CRS), in accordance with patient populations specified for authorized CAR T cell products. Recently, the Food and Drug Administration (FDA) approved a phase III clinical trial of tocilizumab to treat hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) COVID-19 pneumonia.

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 Tocilizumab, just click the ADD TO CART button.

HBEL

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