地舒单抗的使用说明

It is a monoclonal antibody that specifically targets receptor activator of nuclear factor kappa B ligand (RANKL). It can inhibit the activation and development of osteoclasts, reduce bone resorption, and increase bone density. It is used for the treatment of osteoporosis in postmenopausal women and has good safety and effectiveness.

So, what are the instructions for using denosumab?

1. Instructions for use on the prevention of bone-related events caused by bone metastasis from multiple myeloma and solid tumors:

Administer 120 mg by subcutaneous injection into the upper arm, thigh, or abdomen, once every 4 weeks.

2. Instructions for use of giant cell tumor of bone in adults or skeletally mature adolescents who are unresectable or whose surgical resection would lead to serious complications:

Administer by subcutaneous injection in the upper arm, thigh, or abdomen, 120 mg each time, once every 4 weeks. During the first month of treatment, 120 mg will be added on the 8th and 15th days.

3. Instructions for use in bisphosphonate-resistant hypercalcemia:

Administer by subcutaneous injection in the upper arm, thigh, or abdomen, 120 mg each time, once every 4 weeks. During the first month of treatment, 120 mg will be added on the 8th and 15th days.

If necessary, give calcium and vitamin D to treat or prevent hypocalcemia.

In addition, the FDA’s approval of denosumab for the treatment of bone metastases from solid tumors is based on the results of three published pivotal clinical trials.

A comprehensive analysis of these three studies showed that compared with zoledronic acid, denosumab prolonged the time to first adverse bone event (ARE) in patients by 17%, or significantly delayed the median time to first SRE by 8.2 months (27.6 months vs. 19.4 months). months), it also extended the time from the first episode to the recurrence of SRE by 18% in the study; in addition, for patients with mild or no pain at the time of study enrollment, denosumab also significantly prolonged the time to pain exacerbation compared with zoledronic acid.