Denosumab最新说明书

Latest instructions

Denosumab binds to RANKL, a transmembrane or soluble protein that is important for the formation, function and survival of osteoclasts, which are responsible for bone resorption and regulate calcium release in the bone. RANKL can stimulate and enhance osteoclast activity, a process that is a skeletal pathology process of bone metastasis from solid tumors. Similarly, giant cell tumors of bone contain bone stromal cells expressing RANKL and osteoclast-like cells expressing RANK receptors, signaling through RANK receptors to cause osteolysis and tumor growth.

Indications of Denosumab: (1) Prevention of bone-related symptoms in patients with bone metastases from solid tumors (2) Treatment of patients with giant cell tumors of bone who are not suitable for surgery and have mature skeletal systems. (3) Treatment of malignant hypercalcemia that is resistant to bisphosphonates. (4) For refractory malignant hypercalcemia that is insensitive to bisphosphonate drugs. (5) Restricted use: Not used to treat and prevent bone-related symptoms in patients with multiple myeloma.

Denosumab 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. Inject the drug subcutaneously in the upper arm, thigh or abdomen.

Common adverse reactions: (1) The most common adverse reactions (≥25%) in patients with solid tumor bone metastasis are fatigue/asthenia, hypophosphatemia and nausea. (2) Common adverse reactions (≥10%) in patients with giant cell tumor of bone include headache, joint pain, nausea, back pain, fatigue and limb pain. (3) Adverse reactions of malignant hypercalcemia (≥20%) include nausea and vomiting, dyspnea, loss of appetite, headache, peripheral edema, anemia, diarrhea and constipation.