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地诺单抗获批的适应症有哪些?

Author: Medicalhalo
Release time: 2025-10-19 11:44:20

It is the first approved monoclonal antibody specifically targeting RANK ligand. RANKL is a transmembrane or soluble protein that plays an important role in the formation, function, and survival of osteoclasts and cells responsible for bone resorption, regulating the release of calcium from bone. Through RANKL stimulation, osteoclast activity is enhanced, mediating the occurrence of bone metastasis bone pathology in solid tumors. Denosumab can bind to the RANKL protein, preventing RANKL from binding to the receptor RANK expressed on the surface of osteoclasts, precursor cells, and osteoclast-like giant cells to activate subsequent malignant processes, thus exerting an anti-bone metastasis effect. 

Denosumab is currently approved for three indications: (1) Prevention of bone-related events in bone metastases from solid tumors, except for patients with multiple myeloma. Instructions for use: 120mg, once every 4 weeks. Also infuse calcium or vitamin D to prevent hypocalcemia. (2) Unresectable or surgical resection of giant cell tumor of bone in adults or bone-mature adolescents may cause serious complications. Instructions for use: 120mg, once every 4 weeks. In the first month of treatment, add 120mg on the 8th and 15th days respectively. (3) Hypercalcemia in bisphosphonate-resistant malignant tumors. The usage method is the same as the second indication.  

Common side effects: musculoskeletal pain (7.6%), hypercholesterolemia (7.2%), cystitis (5.9%), anemia (3.3%), angina (2.6%), atrial fibrillation (2.0%), dizziness (5.0%), abdominal pain (3.3%), flatulence (2.2%), gastroesophageal reflux disease (2.1%) ), peripheral edema (4.9%), weakness (2.3%), upper respiratory tract infection (4.9%), pneumonia (3.9%), pharyngitis (2.3%), herpes zoster (2.0%), spinal osteoarthritis (2.1%), sciatica (4.6%), insomnia (3.2%), rash (2.5%) , itching (2.2%).

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