地舒单抗是什么？

Also known as denosumab, it is a powerful and effective bone resorption inhibitor and a targeted treatment drug for osteoporosis that targets the osteoclast regulatory pathway. In June 2010, the FDA approved denosumab (trade name: Prolia) for the treatment of osteoporosis in postmenopausal women, and was later approved for the treatment of osteoporosis in men, bone loss caused by androgen deprivation therapy for prostate cancer, and bone loss caused by aromatase inhibitor therapy for breast cancer.

On May 27, 2019, Amgen China announced today that Angavir (English trade name:

Recently, the U.S. Food and Drug Administration (FDA) approved a new indication for denosumab (Xgeva) to treat giant cell tumor of bone (GCTB), a rare and usually benign tumor, in adults and some adolescent patients.

Desosumab can only be given by subcutaneous injection, not by intravenous infusion, intramuscular infusion or intradermal injection. Giant cell tumor of bone: 120 mg subcutaneously every 4 weeks, followed by 120 mg on days 8 and 15 during the first month of treatment. Administer calcium and vitamin D appropriately to prevent hypocalcemia. Bone metastases from solid tumors: 120 mg subcutaneously in the upper arm, thigh, or abdomen every 4 weeks. Malignant hypercalcemia: 20 mg subcutaneously every 4 weeks, followed by 120 mg on days 8 and 15 during the first month of treatment. The medication is injected under the skin in the upper arm, thigh, or abdomen.

Nursing mothers: It is not known whether denosumab is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from denosumab in nursing infants, the decision whether to discontinue breastfeeding or discontinue the drug should be made taking into account the importance of the drug to the mother. According to animal studies, the lack of RANK/RANKL signaling pathway in pregnant mice has shown changes in maternal mammary gland maturation, leading to impaired postpartum lactation. Maternal exposure during pregnancy may impair mammary gland development and lactation.