地舒单抗使用说明

(denosumab) is a monoclonal antibody that binds to RANKL, a protein essential for maintaining bone health. RANKL is also present in giant cell tumors of bone. Denosumab (denosumab) is used in patients whose giant cell tumor of bone cannot be removed by surgery (unresectable) or where surgery would cause severe morbidity (such as amputation or joint removal). Only skeletally mature adolescent patients should use this drug.

"Today's approval of a new indication for denosumab provides an just-needed treatment option for patients with giant cell tumor of bone who are inoperable or whose surgery would cause severe morbidity," said Richard Pazdur, MD, director of the division of hematology and oncology products in the FDA's Center for Drug Evaluation and Research. "The FDA reviewed the drug through the priority review process, which provides an expedited review of the drug. Denosumab was granted orphan drug product designation for the treatment of a rare disease or condition.

Recommended usage and dosage of denosumab (denosumab): (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.