狄诺塞麦是什么药物呢?
What kind of medicine is it? Denosumab was approved for marketing in my country in May 2019. It is a human monoclonal antibody and RANKL inhibitor used for the treatment of adults and skeletally mature adolescent patients with unresectable giant cell tumor of bone or whose surgical resection may cause severe functional impairment.
Denosumab is produced and developed by Amgen. On December 17, 2009, the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on denosumab for the treatment of postmenopausal osteoporosis in women and the treatment of prostate cancer through hormone ablation and bone loss in men. Denosumab was approved for marketing by the European Commission on May 28, 2010.
On June 2, 2010, denosumab was approved by the United States (FDA) for use in postmenopausal women with the risk of osteoporosis, under the trade name Prolia. In November 2010, denosumab was approved for the prevention of bone-related events in patients and the treatment of solid tumors with bone metastases. Denosumab is the first RANKL inhibitor approved by the FDA under the trade name Xgeva.
On June 13, 2013, the U.S. FDA approved denosumab for the treatment of adults and skeletally mature adolescents with giant cell tumors of bone that are unresectable or in which resection would result in significant morbidity.
Giant cell tumor of bone is an extremely rare and rapidly progressing primary bone tumor rich in human nuclear factor activator ligand (RANKL), manifesting as eccentric bony lesions in the metaphysis and epiphysis of long bones or the spine and sacrum. For injection of denosumab, 120 mg needs to be injected subcutaneously in the upper arm, upper thigh, or abdomen, once every 4 weeks. When treatment or prevention of hypocalcemia is required, calcium and vitamin D are given. Hypocalcemia must be corrected before starting treatment. For patients who are prone to hypocalcemia and mineral metabolism imbalance, it is necessary to closely monitor their creatinine and mineral levels in clinical practice, and instruct such patients to pay attention to the symptoms of hypocalcemia and to supplement adequate amounts of calcium and vitamin D.
The above is the introduction of medicines, I hope it will be helpful to you.
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