狄诺塞麦使用说明

It is approved for the prevention of bone-related events in patients with bone metastases from solid tumors. It is not indicated for the prevention of bone-related events in patients with multiple myeloma, or for the treatment of hypercalcemia in adults or bone-mature adolescents with giant cell tumors of bone who are unresectable or surgically resectable malignancies that may cause serious complications and are bisphosphonate-resistant.

Instructions for use of Denosumab are as follows:

Denosumab can only be given by subcutaneous injection, not by intravenous infusion, intramuscular infusion or intradermal injection. Bone metastases from solid tumors: 120 mg subcutaneously in the upper arm, thigh, or abdomen every 4 weeks. 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. 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.

Based on clinical trials using lower doses of denosumab, patients with creatinine clearance less than 30 mL/min or receiving dialysis are at higher risk for severe hypocalcemia compared with patients with normal renal function. In a trial of 55 patients, free of cancer and with varying degrees of renal impairment, receiving a single dose of 60 mg denosumab, 8/17 patients had a creatinine clearance less than 30 mL/min or underwent dialysis and had a corrected serum calcium level less than 8.0 mg/dL compared with 0/12 patients with normal renal function. The risk of hypocalcemia with the recommended dosing regimen of 120 mg every 4 weeks has not been evaluated in patients with creatinine clearance less than 30 mL/min or receiving dialysis.

There is no need to adjust the dose of denosumab in 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.

Use may cause severe hypocalcemia. Correct existing hypocalcemia before treatment with denosumab. Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Monitor levels more frequently when denosumab is administered with other drugs that can also lower calcium levels. Advise patients to seek medical attention for symptoms of hypocalcemia.