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(denosumab, also known as AMG-162, trade name Prolia) is a bone resorption inhibitor with a unique mechanism of action. It specifically targets receptor activator of nuclear factor kappa B (RANK) ligand, inhibits the activation and development of osteoclasts, reduces bone resorption, and increases bone density. 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.

In addition, denosumab is a drug that targets the RANK ligand. Compared with the bisphosphonates that have been used clinically, denosumab has the advantage of significantly prolonging the occurrence time of bone damage-related events. It can be administered subcutaneously and is easy to use. Clinical data shows that the drug does not require monitoring of renal function, while the use of bisphosphonates does. The dosing speed is determined based on the patient's renal function monitoring; however, denosumab is currently relatively expensive, and the balance between its long-term efficacy and cost-effectiveness needs to be further confirmed. It is expected that denosumab, a drug specifically targeting RANK ligand inhibitors, can obtain more valuable research results in the treatment of solid tumors and bring new hope to patients with bone metastasis.

Recommended usage and dosage: (1) Denosumab can only be injected subcutaneously, not intravenously, intramuscularly or intradermally. (2) Solid tumor bone metastasis: 120mg once every 4 weeks, injected subcutaneously in the upper arm, thigh or abdomen. (3) Giant cell tumor of bone: 120 mg once every 4 weeks, subcutaneous injection, and then 120 mg on d8 and d15 in the first month of treatment. (4) Administer calcium and vitamin D appropriately to prevent hypocalcemia. (5) Malignant hypercalcemia: 20 mg once every 4 weeks, subcutaneous injection, and then 120 mg on d8 and d15 in the first month of treatment. The medication is injected under the skin in the upper arm, thigh, or abdomen.

Use in Special Populations: Pregnancy: May cause fetal harm based on animal data. Pregnancy monitoring programs are available. Nursing Mothers: Breast development and lactation may be impaired. Discontinue medication or breastfeeding. Pediatric Patients: Safety and effectiveness have not been established. Renal Impairment: Patients with creatinine clearance less than 30mL/min or receiving dialysis are at risk for hypocalcemia. Appropriate supplements of calcium and vitamin D.