Denosumab (Xgeva) should not be prescribed to patients with unhealed lesions from dental or oral surgery, the TGA has confirmed in its latest Medicines Safety Update.
Osteonecrosis of the jaw (ONJ) is already a known adverse event highlighted in the PI documents of both brands marketed in Australia – Prolia and Xgeva.
However the TGA says because Xgeva is given at higher dose and administered more frequently than Prolia, the risk of ONJ is increased.
Clinicians should also advise patients taking either Xgeva or Prolia to practice good oral hygiene during treatment.
Furthermore if deemed necessary preventive dentistry may be recommended prior to treatment, especially in patients at high-risk of ONJ.
“If invasive dental procedures during treatment cannot be avoided, consider the individual circumstances of the patient to determine an appropriate management plan,” the TGA advises.
If ONJ occurs during treatment a temporary interruption of therapy should be considered based on individual risk-benefit assessment.