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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: March 2018 - ARP Practice Committee
The information contained in this biologic reference guide is offered solely for purposes of providing health care professionals with a quick and initial reference. Before prescribing or administering any drug contained in this biologic reference guide, health professionals should read the manufacturer’s complete prescribing information in order to be informed of the various clinical considerations to be taken into account. The American College of Rheumatology is providing this information as a benefit and service in furtherance of its educational mission. By providing this information, ACR is not endorsing or recommending any of the listed companies or any of their drugs or other products. The information contained in the biologic reference guides reflect the conclusions of the individual companies and not those of the ACR which specifically disclaims any responsibility or liability for the use of such information and/or for the performance of any of the drugs listed in this biologic reference guide.