Xgeva使用说明

Denosumab can only be given by subcutaneous injection, not by intravenous infusion, intramuscular infusion or intradermal injection. Giant cell tumor of bone: 120 mg subcutaneously every 4 weeks, followed by 120 mg on days 8 and 15 during the first month of treatment. Administer calcium and vitamin D appropriately to prevent hypocalcemia. Bone metastases from solid tumors: 120 mg subcutaneously in the upper arm, thigh, or abdomen every 4 weeks. Malignant hypercalcemia: 20 mg subcutaneously every 4 weeks, followed by 120 mg on days 8 and 15 during the first month of treatment. The medication is injected under the skin in the upper arm, thigh, or abdomen.

Nursing mothers: It is not known whether denosumab Xgeva is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from denosumab in nursing infants, the decision whether to discontinue breastfeeding or discontinue the drug should be made taking into account the importance of the drug to the mother. Based on animal studies in pregnant mice lacking the RANK/RANKL signaling pathway that have shown altered maternal mammary gland maturation, resulting in impaired postpartum lactation, maternal exposure to denosumab during pregnancy may impair mammary gland development and lactation.

Pediatric Use: The safety and effectiveness of denosumab Xgeva in pediatric patients have not been established. Treatment with denosumab may impair bone growth in children with open growth plates and may inhibit delayed eruption of permanent teeth.

Geriatric Use: In the trial, 1,260 patients (44%) who received denosumab Xgeva were 65 years or older. No overall differences in safety or efficacy were observed between these patients and younger patients. For use in patients with renal impairment. In a trial of 55 patients without cancer and with varying degrees of renal function who received a single dose of 60 mg of The risk of hypocalcemia with the recommended dosage regimen of 120 mg every 4 weeks has not been evaluated in patients with creatinine clearance less than 30 mL/min or receiving dialysis.

Pregnancy: Category C. There are no appropriate and well-controlled trials of denosumab in pregnant women. Denosumab Xgeva should be used during pregnancy only if the potential benefits justifiably outweigh the potential risks to the fetus. Women who become pregnant during denosumab treatment are encouraged to enroll in Amgen's pregnancy monitoring program.