美国安进地舒单抗注射方法

FDA-approved for use in postmenopausal women with osteoporosis who are at high risk for fracture, to help reduce the incidence of vertebral, non-vertebral and hip fractures in postmenopausal women with osteoporosis. Desosumab is also used to reduce the risk of fractures in patients for whom other current treatments are ineffective or intolerable. So, let’s take a look at the Amgen denosumab injection method in the United States.

Desosumab is easy to use and can be injected subcutaneously by the patient at 60 mg/time with an interval of 6 months. While being treated with this drug, patients need to take 1000mg of calcium and at least 4001U of vitamin D every day. It is worth noting that unlike bisphosphonates, which have longer-term effects, denosumab does not bind to its receptors for long-term retention.

Amgen’s denosumab is the first approved monoclonal antibody that specifically targets a 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.   

Large-scale clinical trials abroad have proven that denosumab can significantly improve bone turnover markers (BTM) in postmenopausal osteoporosis patients, including a significant reduction in the bone resorption markers C-telopeptide of type I collagen (CTX) and N-telopeptide of type I procollagen (PINP). At the same time, the bone mineral density (BMD) of the subjects' lumbar spine and hip joints was significantly increased. In its 2010 guidelines for the treatment of postmenopausal osteoporosis, the American Society of Clinical Endocrinologists listed denosumab as a first-line drug along with bisphosphonates.

On May 27, 2019, it was approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or that may result in severe functional impairment if surgical resection, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).