地诺单抗（Xgeva）使用说明

(Xgeva) is a synthetic, fully humanized monoclonal antibody (IgG2 antibody) that can bind to RNAKL. It has high affinity and specificity for human RANKL. It is the first drug to prevent local osteolysis and bone erosion through anti-bone resorption. It is also the only approved antagonist drug targeting RANKL so far. Denosumab (Xgeva) was approved by the FDA in 2009 to treat postmenopausal osteoporosis, and is used to treat bone destruction caused by breast cancer, prostate cancer bone metastasis, and multiple myeloma.

Recommended usage and dosage of denosumab (Xgeva): (1) Denosumab (Xgeva) can only be injected subcutaneously, and cannot be infused 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.

There are currently no studies on the effectiveness and safety of this product in children, so denosumab (Xgeva) is not recommended for children.

There is no need to adjust the dosage for the elderly and patients with renal insufficiency. For patients with severe renal insufficiency and those undergoing dialysis treatment, blood calcium monitoring should be carried out, and calcium and vitamin D supplementation should be paid attention to.

It is not yet clear whether denosumab (Xgeva) can be excreted in breast milk. Breast-feeding women should weigh the importance of this product to them and choose to discontinue the drug or stop breastfeeding.

Hypocalcemia must be corrected before starting treatment with this product. For patients who are prone to hypocalcemia and mineral metabolism imbalance (for example, those with a history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malnutrition, small bowel resection, severe renal insufficiency), it is necessary to closely monitor their creatinine and mineral levels (such as phosphorus and magnesium), and instruct such patients to pay attention to the symptoms of hypocalcemia and to supplement adequate amounts of calcium and vitamin D.

Patients who are concurrently taking immunosuppressants or have compromised immune systems may be at increased risk of serious infections, and physicians need to fully consider the benefit-risk ratio before prescribing denosumab to these patients. For patients who develop serious infections while using Xgeva, physicians should evaluate the need to continue treatment with this product.