狄诺塞麦（地诺单抗）说明书

(Denosumab) Instructions

Generic name: denosumab

Product name: Xgeva

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

Indications: (1) Prevention of bone-related symptoms in patients with solid tumor bone metastasis. (2) Treat 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.

Usage and dosage:

Denosumab (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 (denosumab) 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 (denosumab) 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 (denosumab) 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 60 mg dose of denosumab (denosumab), patients with creatinine clearance less than 30 mL/min or receiving dialysis were at higher risk for severe hypocalcemia with denosumab compared with patients with normal renal function. 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 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.

Adverse reactions:

Anemia (3.3%), angina (2.6%), atrial fibrillation (2.0%), dizziness (5.0%), abdominal pain (3.3%), flatulence (2.2%), gastroesophageal reflux disease (2.1%), peripheral edema (4.9%), weakness (2.3%), Upper respiratory tract infection (4.9%), pneumonia (3.9%), pharyngitis (2.3%), herpes zoster (2.0%), spinal osteoarthritis (2.1%), sciatica (4.6%), insomnia (3.2%), rash (2.5%), itching (2.2%).

Things to note:

(1) Do not use the same active drug: Patients taking denosumab (denosumab) should not use denosumab. (2) Allergic reactions may occur when using denosumab; if allergic reactions occur, the medication should be discontinued permanently. (3) Hypocalcemia: Denosumab (denosumab) may cause severe symptoms of hypocalcemia, or be fatal. Hypocalcemia should be corrected before medication, and the patient's blood calcium level should be monitored during treatment, especially in the first week of first medication, and calcium and vitamin D should be supplemented appropriately. (4) Osteonecrosis of the jaw (ONJ): Osteonecrosis of the jaw (ONJ) ​​has been reported. Oral examination should be performed before medication, symptoms should be observed during treatment, and any invasive dental procedures should be avoided. (5) Atypical femoral fracture: Assess the patient’s thigh or groin pain to diagnose atypical femoral fracture. (6) Hypercalcemia after discontinuation of medication: Monitor patient’s symptoms and treat appropriately. (7) Embryo-fetal toxicity: (denosumab) harms the fetus. Women of childbearing age should be informed of the dangers of this drug and take effective contraceptive measures.