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XGEVA (denosumab)

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XGEVA® posology & method of administration

XGEVA® (DENOSUMAB) POSOLOGY & METHOD OF ADMINISTRATION

The XGEVA® injection is a sterile, preservative-free solution administered as a subcutaneous injection. XGEVA® injections should be administered under the supervision of a healthcare professional.[CHMP AR, p. 8; SmPC, p. 2]

All patients treated with XGEVA® should receive at least 500 mg calcium and 400 IU vitamin D daily, unless they have hypercalcaemia.[SmPC, p. 2]

Patients treated with XGEVA® should be given the package leaflet and the patient reminder card.[SmPC, p.2]

Pack contents, storage information and disposal information 

Nature and contents of container

  • The XGEVA® injection is available as a 1.7 ml solution in a single use vial (type I glass) with stopper (fluoropolymer coated elastomeric) and seal (aluminum) with a flip-off cap.[SmPC, p. 15]
  • Pack sizes of one, three or four vials are available.[SmPC, p. 15]

Shelf life

  • XGEVA® has a shelf life of three years.[SmPC, p. 15]
  • XGEVA® may be stored at room temperature (25°C) for up to 30 days in the original container, but once removed from the refrigerator XGEVA® must be used within this 30-day period.[SmPC, p. 15]

Special precautions for storage

  • XGEVA® should be stored in a refrigerator (2–8°C).[SmPC, p. 15]
  • The vial containing XGEVA® should be kept in the outer carton to protect it from light.[SmPC, p. 15]
  • XGEVA® should not be frozen.[SmPC, p. 15]

Special precautions for disposal

  • Unused medicinal product and other waste materials should be disposed of according to local regulations.[SmPC, p. 16]

XGEVA® (denosumab) dose

XGEVA® injections are given once every four weeks as a single injection. The recommended XGEVA® injection dose is 120 mg. The dose is the same for patients with giant cell tumour of bone, with additional 120 mg doses administered on days 8 and 15 of the first month of therapy.[SmPC, pp. 2-3]

XGEVA® (Denosumab) administration [SmPC, pp. 2,15-16]

  • Before injection, the XGEVA® solution should be inspected visually.
  • The solution may contain trace amounts of translucent to white protein particles, but should not be used if it is cloudy or discoloured.
  • Do not shake excessively.
  • Allow the vial to reach room temperature before injecting, as this will reduce pain at the site of injection.
  • The entire contents of the vial should be injected.
  • XGEVA® injections are administered subcutaneously in the thigh, abdomen or upper arm.
  • A 27-gauge needle is recommended for administration.
Learn more about the XGEVA® (denosumab) safety profile.