美国安进地舒单抗注射液的中文说明书

[Drug name], denosumab, denosumab, Xgeva, Denosumab

[Indications] It is suitable for preventing bone-related events in patients with bone metastases from solid tumors.

[Recommended dose] Give 120 mg by subcutaneous injection in the upper arm, upper thigh, or abdomen, once every 4 weeks. 120 mg/1.7 mL (70 mg/mL) single use vial.

【Side effects】

>10% side effects: back pain (incidence rate 34.7%), limb pain (11.7%).

<10% of side effects: musculoskeletal pain (7.6%), hypercholesterolemia (7.2%), cystitis (5.9%), 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%).

[Notes] Hypocalcemia must be corrected before denosumab treatment is initiated. 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. 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.

The above instructions are instructions, please consult your doctor.