Cladribine is indicated for use in the treatment of active hairy cell leukemia (leukemic reticuloendotheliosis) and highly active relapsing multiple sclerosis (RMS). It is also used as an alternative treatment agent for chronic lymphocytic leukemia (CLL), low-grade non- Hodgkin’s lymphoma, and cutaneous T-cell lymphoma. While the exact mechanism of action has not been fully determined, there is evidence showing cladribine is phosphorylated which accumulates and is incorporated into DNA in cells, such as lymphocytes. This incorporation results in DNA strand breaks and inhibition of DNA synthesis and repair, ultimately resulting in ATP depletion and apoptosis. Cladribine has cytotoxic effects on resting and proliferative lymphocytes. It leads to cells accumulating at the G1/S phase junction, suggesting cytotoxicity may be associated with events critical to S phase entry. Cladribine’s effects in RMS are not fully understood, but its effects on lymphocytes could potentially interrupt the cascade of immune events central to MS. The mechanism of action in hairy cell leukemia is unknown.

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.


CAS Registry Number:
Trade names:
Leustatin®, Litak®, Mavenclad®
$679 USD


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 Cladribine, just click the ADD TO CART button.


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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.
  • K. Rosenthal
  • Director of Manufacturing