美国安进地舒单抗注射液国内有吗

In June 2010, the FDA approved Amgen's drug for the treatment of osteoporosis in postmenopausal women, and was later approved for the treatment of male osteoporosis, bone loss caused by androgen deprivation therapy for prostate cancer, and bone loss caused by aromatase inhibitor therapy for breast cancer.

In 2019, denosumab was approved for marketing in my country for the treatment of giant cell tumors of bone that are unresectable or that may result in severe functional disability after surgical resection, including adults and adolescent patients with mature bone development (defined as at least 1 mature long bone and a weight of ≥45 kg).

Desosumab is the first approved monoclonal antibody that specifically targets RANK ligand. RANK ligand is a transmembrane or soluble protein that is necessary for osteoclasts to maintain their structure, function, and survival. Human RANKL mRNA is mainly found in bones, bone marrow and lymphoid tissues. Its main function in bones is to stimulate the differentiation and activity of osteoclasts and inhibit the apoptosis of osteoclasts.

Desosumab has a high affinity for RANKL, preventing RANK ligands from activating RANK on the surface of osteoclasts, inhibiting osteoclast activation and development, reducing bone resorption, increasing bone density and bone strength of both cortical bone and trabecular bone, promoting bone reconstruction, and reducing the incidence of vertebral, non-vertebral and hip fractures in postmenopausal osteoporotic women.

The recommended dose for the prevention of bone-related events in solid tumor bone metastases is 120 mg administered by subcutaneous injection (upper arm, upper thigh, or abdomen) every 4 weeks, along with calcium or vitamin D infusion to prevent hypocalcemia. NOTE: Not for use in patients with multiple myeloma for prophylaxis of bone-related events.

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