DENOSUMAB is a fully human, highly specific, monoclonal antibody to receptor activator of nuclear factor kappa-B ligand (RANKL). The antibody is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Denosumab binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts; the cells responsible for bone resorption. Denosumab prevents RANKL from activating on its receptor, RANK, present on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone. Ultimately, denosumab blocks osteoclast activation, thereby resulting in decreased bone resorption (less bone breakdown).
Patient Medication Guide
Full Prescribing Information
Denosumab is indicated for:
These risks should be discussed with patients. A non-promotional Patient Counseling Toolkit is available through 1-800-77-AMGEN (1-800-772-6436).
Denosumab should be administered by a healthcare professional.
Latex Allergy: People sensitive to latex should not handle the grey needle cap on the single-use prefilled syringe, which contains dry natural rubber (a derivative of latex).
Instructions for Prefilled Syringe with Needle Safety Guard
Instructions for Single-use Vial
Updated: February 2020 - ARP Practice Committee
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