狄诺塞麦最新版说明书

The latest version of the manual

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

【Indications】

1. Prevent skeletal-related events in patients with multiple myeloma and patients with bone metastasis from solid tumors.

2. Treat adult patients with giant cell tumors of bone who are not suitable for surgery and have mature skeletal systems.

3. Treatment of hypercalcemia of malignant tumors that are resistant to bisphosphonates.

4. It is not used to treat patients with multiple myeloma and prevent their bone-related symptoms.

【Usage and Dosage】

Recommended dose: Denosumab 120 mg subcutaneously injected into the upper arms, upper thighs, and abdomen 1/4 week.

Calcium and vitamin D can treat or prevent hypocalcemia.

Prior to administration, denosumab may be removed from the refrigerator and placed in the original container at room temperature (up to 25°C/77°F). It usually takes 15 to 30 minutes. Do not use any other method of heating.

Use a 27-gauge needle to aspirate the entire contents of the injection vial. Do not re-enter vial, single use or discard vial after entry,

Dosage form and strength: 120mg/1.7mL (70mg/mL) single-use vial.

[Adverse Reactions] The most common adverse reactions in patients with solid tumor bone metastasis are fatigue/asthenia, hypophosphatemia and nausea.

Common adverse reactions in patients with giant cell tumor of bone include headache, joint pain, nausea, back pain, fatigue and pain in the extremities.

Adverse effects of malignant hypercalcemia include nausea and vomiting, dyspnea, decreased appetite, headache, peripheral edema, anemia, diarrhea, and constipation.

The most common adverse reactions (≥10%) in multiple myeloma are diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.

【Notes】

1. Do not use the same active drug: Patients taking denosumab should not use Prolia.

2. Allergic reactions may occur when using denosumab; if allergic reactions occur, the medication should be discontinued permanently.

3. Hypocalcemia: Denosumab may cause symptomatic hypocalcemia, which may be fatal. Hypocalcemia should be corrected before medication, and the patient's blood calcium level should be monitored during treatment, 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: It will harm the fetus. Inform women of childbearing age about the dangers of this drug and take effective contraceptive measures.