狄诺塞麦适用于什么病症？

In May 2019, it was approved for marketing in China. Due to its relatively short time on the market, many patients do not know much about it. What diseases is denosumab suitable for?

On May 28, 2010, the European Commission approved denosumab for the treatment of bone loss associated with hormone suppression in postmenopausal women with osteoporosis and prostate cancer. It can also be used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures. Denosumab was approved for the first time in 27 EU member states, as well as Norway, Iceland, and Liechtenstein. In June of the same year, denosumab was approved by the FDA for marketing.

In a phase III randomized, controlled clinical study led by Fizazi, the subjects were patients with prostate cancer bone metastases that were resistant to hormone therapy. Compared with zoledronic acid, denosumab also achieved encouraging results in terms of efficiency and safety in treating bone metastases. Denosumab showed advantages over zoledronic acid in delaying or preventing the first SHE.

On May 27, 2019, Amgen China announced that denosumab injection (denosumab) has been approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or whose surgical resection may cause severe dysfunction, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).

Denosumab is administered by subcutaneous injection, 120 mg in the upper arm, upper thigh, or abdomen, once every 4 weeks. Calcium and vitamin D are given when treatment or prevention of hypocalcemia is required.

Allergic reactions may occur during use; if allergic reactions occur, use should be discontinued permanently. Hypocalcemia: Denosumab may cause severe symptoms of hypocalcemia, which may be fatal. Embryo-fetal toxicity: Denosumab is harmful to the fetus. Women of childbearing age should be informed of the dangers of this drug and take effective contraceptive measures.