Denosumab (Xgeva)

General information

Class/mechanism: Human IgG2 monoclonal antibody that inhibits RANK ligand (RANKL). RANKL promotes the formation, function, and survival of osteoclasts, which are responsible for bone resorption.
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Giant cell tumor of bone

Patient drug information

• Denosumab (Xgeva) patient drug information (Chemocare)
• Brief patient counseling information can be found on page 15 of the Denosumab (Xgeva) package insert
• Denosumab (Xgeva) patient drug information (UpToDate)

History of changes in FDA indication

• 6/1/2010: FDA approved (as Prolia) for "treatment of postmenopausal women with osteoporosis at high risk for fracture."
• 11/18/2010: FDA approved for "prevention of skeletal-related events in patients with bone metastases from solid tumors."
• 6/13/2013: FDA approved for "treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity."

Also known as

Prolia.