地诺单抗的中文说明书

Chinese manual

Generic name: denosumab

Product name: Xgeva

Full names: denosumab, denosumab, denosumab, Xgeva, Denosumab

Specifications: 120mg/1.7ml; solution

Indications:

(1) Bone metastasis from solid tumors: It is suitable for preventing bone-related events in patients with bone metastases from solid tumors. (2) Important limitations of use: Not suitable for prevention of bone-related events in patients with multiple myeloma.

Usage and dosage:

(1) Xgeva can only be administered by subcutaneous injection, not intravenous infusion, intramuscular infusion or intradermal injection. (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. 95) Malignant hypercalcemia: 120 mg once every 4 weeks, subcutaneously, and another 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.

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.

Storage: Store in refrigerator at 2-8°C in original box. Do not freeze, once removed from the refrigerator, do not expose to temperatures above 25°C or light, must be used within 14 days.

Things to note:

Hypocalcemia must be corrected before starting treatment. For patients who are prone to hypocalcemia and mineral metabolism imbalance (such as those with a history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malnutrition, small bowel resection, severe renal insufficiency), clinical monitoring of creatinine and mineral levels is required, and such patients should be instructed 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 such patients. Physicians should evaluate the need to continue denosumab therapy in patients who develop serious infections while taking denosumab. Osteonecrosis of the jaw often occurs with tooth extraction and local infection that delays healing. A routine oral examination should be performed before starting denosumab treatment, and good oral hygiene should be maintained after treatment is started. If a patient develops osteonecrosis of the jaw, treatment for osteonecrosis of the jaw may worsen the condition, and discontinuation of the medication should be considered at this time.