AMGEN Denosumab xgfva 120mg

I. Basic Drug Information

Generic Name: Denosumab

Brand Name: Xgeva

Dosage Form: Solution for injection (120 mg/1.7 mL, single-dose vial)

Manufacturer: Amgen Inc.

Pharmacological Class: Humanized IgG2 monoclonal antibody; targets RANK ligand (RANKL), inhibits osteoclast activity, and reduces bone resorption.

II. Indications

1. Bone metastases from solid tumors: Prevention of skeletal-related events (e.g., pathologic fracture, spinal cord compression) in patients with bone metastases from solid tumors (such as prostate cancer and breast cancer). 

*Note: Not indicated for the prevention of skeletal events in multiple myeloma.*

2. Giant cell tumor of bone (GCTB): Treatment of GCTB that is unresectable or where surgical resection is likely to result in severe morbidity (in adults and skeletally mature adolescents weighing ≥45 kg).

3. Hypercalcemia of malignancy (HCM): Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

III. Administration and Dosage

Route of Administration

Subcutaneous injection only: Administer in the upper arm, upper thigh, or abdomen; do not administer intravenously, intramuscularly, or intradermally. Recommended Dosage:

| Indication              | Dosing Regimen                                     | Supplemental Requirements

| Bone metastases from solid tumors | 120 mg every 4 weeks                               | Calcium + Vitamin D (to prevent hypocalcemia)

| Giant cell tumor of bone | 120 mg every 4 weeks; additional 120 mg doses on Days 8 and 15 of the first month | Calcium + Vitamin D (mandatory supplementation)

| Malignant hypercalcemia | Same regimen as for giant cell tumor of bone       | Calcium + Vitamin D (monitor serum calcium levels)

Precautions for Use

1. Pre-treatment:

Correct hypocalcemia prior to administration;

Monitor serum calcium, phosphorus, and creatinine levels every 4 weeks, especially in patients with renal impairment (creatinine clearance <30 mL/min).

2. Administration steps:

Allow refrigerated medication to reach room temperature (≤25°C) for 15–30 minutes before use;

Visually inspect before injection: solution should be clear and colorless to pale yellow; discard if cloudy, discolored, or containing particulates;

Withdraw using a 27-gauge needle; discard the vial after a single use.

IV. Adverse Reactions

Common adverse reactions (≥25%)

- Fatigue/asthenia (45%), hypophosphatemia (32%), nausea (31%).

- Others: diarrhea (20%), dyspnea (21%), headache (13%).

Serious adverse reactions

1. Hypocalcemia:

Incidence rate of 18% (Xgeva group vs. 9% in zoledronic acid group); severe hypocalcemia (serum calcium <7 mg/dL) occurred in 3.1% of patients.

*Management*: Mandatory calcium and Vitamin D supplementation during treatment; regular monitoring of serum calcium.

2. Osteonecrosis of the jaw (ONJ):

Annual incidence increases with prolonged treatment (1.1% in Year 1, 3.7% in Year 2, 4.6% at ≥3 years).

*Prevention*: Oral examination prior to treatment; avoid invasive dental procedures during treatment. 3. Atypical femoral fractures:

Associated with long-term treatment; monitor for thigh or groin pain.

4. Risks upon treatment discontinuation:

May trigger hypercalcemia (in adolescent GCTB patients) or multiple vertebral fractures (MVF).

V. Contraindications

1. Hypersensitivity to denosumab or excipients;

2. Uncorrected hypocalcemia.

VI. Use in Special Populations

Pregnancy/Lactation:

- Pregnancy Category C (animal studies indicate fetal risk); use contraception during treatment and avoid pregnancy for 5 months after discontinuation;

- Contraindicated during lactation (may impair mammary gland development and milk secretion).

Pediatric: Restricted to adolescents with skeletal maturity (must meet bone maturity criteria); contraindicated in skeletally immature children (may inhibit bone growth and permanent tooth eruption).

Elderly/Renal Impairment:

- No dose adjustment required for elderly patients;

- Renal failure (creatinine clearance <30 mL/min or dialysis patients): monitor closely for hypocalcemia.

VII. Drug Interactions

Bisphosphonates: Concomitant use prohibited (additive bone-suppressive effects);

Immunosuppressants: May increase the risk of serious infections; assess the benefit-risk ratio.

VIII. Storage Conditions

Refrigeration: Store at 2–8°C in the original packaging; do not freeze or shake;

After opening: Use within 14 days at room temperature (≤25°C); discard if this period is exceeded or if exposed to high temperatures/light.

IX. Packaging and Shelf Life

Specification: 120 mg/1.7 mL/vial (single-dose vial);

Shelf life: 36 months (expiry date indicated on the label).

> The above information is compiled from the drug package insert and clinical studies; specific use must follow medical advice. During treatment, regularly monitor blood calcium, oral health, and renal function, and promptly report abnormal symptoms such as bone pain or jaw numbness. Specifications

Product Name: Xgeva (Denosumab) Injection 120 mg (1.7 mL) × 1 vial

Common Name: Xgeva

Active Ingredient: Denosumab

Dosage Form: Injection

Specification: 120 mg/1.7 mL, single-dose vial

Manufacturer: Amgen Inc. (USA)

Indications:

1. Bone metastases from solid tumors: Prevention of skeletal-related events (e.g., pathological fractures, spinal cord compression) in patients with bone metastases from solid tumors (such as prostate cancer or breast cancer).

*Note: Not indicated for the prevention of skeletal events in multiple myeloma.*

2. Giant Cell Tumor of Bone (GCTB): Treatment of GCTB that is unresectable or where surgical resection is likely to result in severe morbidity (in adults and skeletally mature adolescents weighing ≥45 kg).

3. Hypercalcemia of Malignancy (HCM): Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Dosage and Administration:

1. Bone metastases from solid tumors / Multiple myeloma

Dosage: 120 mg administered subcutaneously (upper arm, thigh, or abdomen) once every 4 weeks.

Precautions: Correct hypocalcemia prior to administration; monitor serum calcium levels during treatment; supplement with calcium and vitamin D as necessary.

2. Giant Cell Tumor of Bone (unresectable or high surgical risk)

Dosage: 120 mg administered subcutaneously once every 4 weeks; additional doses may be administered on Day 8 and Day 15 of the first month (totaling 3 doses in the first month).

Treatment Duration: Continue until disease progression or the occurrence of intolerable toxicity.