OEL Fastrac Catalog

Aprepitant is indicated for the prevention of nausea and vomiting associated with highly or moderately emetogenic cancer chemotherapy, including high-dose cisplatin (in combination with other antiemetic agents). Aprepitant is a selective high-affinity antagonist of human substance P (neurokinin 1, NK1) receptors. Aprepitant has little or no affinity for serotonin (5-HT3), dopamine and corticosteroid receptors, the targets of existing therapies for chemotherapy-induced nausea and vomiting (CINV). It has been shown in animal models to inhibit emesis induced by cytotoxic chemotherapeutic agents, such as cisplatin via central actions. Animal and human Positron Emission Tomography (PET) studies with aprepitant have demonstrated that it crosses the blood brain barrier and occupies brain NK1 receptors. Aprepitant augments the antiemetic activity of the 5-HT3-receptor antagonist ondansetron and the corticosteroid dexamethasone and inhibits both the acute and delayed phases of cisplatin-induced emesis.

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 Aprepitant, just click the ADD TO CART button.

HBEL

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