Denosumab safety update

Denosumab is associated with a risk of osteonecrosis of the jaw (ONJ) and with a risk of hypocalcaemia. Before starting denosumab treatment, a dental examination and appropriate preventive dentistry are now recommended to reduce the risk of osteonecrosis of the jaw. This applies to:

  • all patients considered for denosumab 120mg for cancer
  • to patients with ONJ risk factors considered for denosumab 60mg for osteoporosis. These are:
      • smoking
      • old age (this is not defined)
      • poor oral hygiene
      • invasive dental procedures (e.g., tooth extractions, dental implants, oral surgery)
      • comorbidity (e.g., dental disease, anaemia, coagulopathy, infection)
      • advanced cancer
      • previous treatment with bisphosphonates
      • concomitant treatments (e.g,, chemotherapy, antiangiogenic biologics, corticosteroids, radiotherapy to head and neck)

Tell patients to maintain good oral hygiene and report any oral symptoms.

The risk of hypocalcaemia increases with the degree of renal impairment. Monitor calcium levels depending on the indication as described below and tell patients to report symptoms of hypocalcaemia (e.g,, muscle spasms, twitches, or cramps; numbness or tingling in the fingers, toes, or around the mouth).