Denosumab

Red

Brand Name(s):Prolia

Indication:Hypercalcaemia for patients resistent to Zolendronate

Rationale:1,2

Considered:Jan-15

Review Date:Oct-25

Comments:
Drug Safety Update –
* an increased risk of multiple vertebral fractures has been reported in patients within 18 months of stopping or delaying ongoing denosumab 60mg treatment for osteoporosis; cases have been reported in patients in the UK
* patients with a previous vertebral fracture may be at highest risk
* evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab, particularly in patients at increased risk of vertebral fractures for example those with previous vertebral fracture
* patients should not stop denosumab without specialist review
* the optimal duration of denosumab treatment for osteoporosis has not been established; re-evaluate the need for continued treatment periodically based on the expected benefits and potential risks of denosumab on an individual patient basis, particularly after 5 or more years of use
* risks of long-term treatment with denosumab include rare cases of osteonecrosis of the jaw and atypical femoral fractures, osteonecrosis of the external auditory canal have been reported.
* NICE advises not to postpone ongoing treatment with denosumab during the coronavirus (COVID-19) pandemic
MHRA August 2020 Drug Safety Update
Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab
June 2017