狄诺塞麦中文说明书

Chinese instruction manual

Generic name: denosumab

Product name: Xgeva

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

Indications:

Denosumab is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Important limitations of use: Denosumab is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

Dosage and Administration:

(1) Administer 120 mg subcutaneously/injection into the upper arm, upper thigh, or abdomen once every 4 weeks

(2) Give calcium and vitamin D when necessary to treat or prevent hypocalcemia

Adverse reactions:

Anemia 3.3%, angina pectoris 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%, and pruritus 2.2%.

Things to note:

Hypocalcemia must be corrected before initiating treatment with denosumab. 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 also taking immunosuppressants or whose immune systems are compromised may be at increased risk of serious infections. Physicians must fully consider the benefit and risk ratio before prescribing denosumab (desosumab) to such patients. Physicians should evaluate the need to continue treatment with denosumab (desosumab) 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 treatment with denosumab, 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.

Denosumab (desosumab) for use in special populations:

Pregnancy: May cause fetal harm based on animal data. Pregnancy monitoring programs are available.

Nursing Mothers: Breast development and lactation may be impaired. Discontinue medication or breastfeeding.

Pediatric Patients: Safety and effectiveness have not been established.

Renal Impairment: Patients with creatinine clearance less than 30mL/min or receiving dialysis are at risk for hypocalcemia. Appropriate supplements of calcium and vitamin D.

(Denosumab) Storage: Refrigerate at 2-8°C (36-46°F); do not freeze; must be used within 14 days after removal from the refrigerator and do not expose to temperatures above 25°C (77°F); avoid direct light and heat.