Xgeva (Denosumab) – GCTB | HongKong DengYue Medicine

Xgeva Application Scope

Xgeva is a prescription medication indicated for:

• Prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and in patients with multiple myeloma.

• Treatment of giant cell tumor of bone (GCTB) in adults and skeletally mature adolescents with unresectable tumors or where surgical resection is likely to result in severe morbidity.

  

Xgeva Characteristics

• Ingredients: Denosumab

• Properties:​ Sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous injection

• Packaging Specification:​ Single-use vial containing 120 mg of denosumab in 1.7 mL solution

• Storage:​ Store in a refrigerator at 2°C to 8°C (36°F to 46°F); do not freeze.

• Expiry Date: Refer to the expiry date printed on the packaging

• Executive Standard: ​Complies with the standards set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)

• Approval Number:

  • FDA: 125320

  • EMA: EU/1/11/682/001

• Date of Revision: Refer to the latest prescribing information for the most current revision date

• Manufacturer: Amgen Inc.

Guidelines for the Use of Xgeva

• Dosage and Administration:

  • Recommended Dose:

    • For SRE Prevention: 120 mg administered subcutaneously every 4 weeks.

    • For GCTB Treatment: 120 mg administered subcutaneously every 4 weeks, starting one week after the first dose.

  • Administration:

    • Administer as a subcutaneous injection by a healthcare professional.

    • Rotate injection sites to minimize discomfort.

  • Missed Dose:​ If a dose is missed, administer as soon as possible and resume the regular dosing schedule.

• Adverse Reactions:

  • Common Adverse Reactions:

    • Back pain

    • Pain in extremity

    • Musculoskeletal pain

    • Hypercholesterolemia

    • Cystitis

  • Serious Adverse Reactions:

    • Hypocalcemia (may be severe)

    • Osteonecrosis of the jaw

    • Atypical femoral fractures

    • Serious infections

    • Dermatologic reactions (e.g., eczema, rashes)

    ​

• Contraindications:

  • Hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy.

  • Hypersensitivity: Known clinically significant hypersensitivity to denosumab or any component of the product.

• Precautions:

  • Calcium Levels: Monitor calcium levels, especially in the first weeks of therapy.

  • Dental Health: Perform a dental examination prior to initiation; maintain good oral hygiene.

  • Pregnancy Category: Category D (U.S.)—may cause fetal harm.

Xgeva Interactions

• Other Denosumab Products: Concurrent use of Xgeva with other denosumab products (e.g., Prolia) is not recommended.

• Calcium-Lowering Agents: Use caution when combining with other medications that lower calcium levels.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.