This website uses cookies to ensure that we give you the best experience on our website. Click here for more information.

ok
XGEVA (denosumab)

Terms of Use

The information contained in this site is for healthcare professionals only.

I am not a healthcare professional I confirm to be a healthcare professional
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.