Lancashire and South Cumbria
Formulary
 
back
6 Endocrine system
06-06-02 Denosumab

Denosumab Prolia®
Formulary

Injection 60mg/mL pre-filled syringe

Licensed for treatment of postmenopausal osteoporosis in women at increased risk of fractures and for the treatment of bone loss associated with hormone ablation in men with prostate cancer. See NICE guideline TA204

Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture

Link  MHRA Drug Safety Update May 2022: Denosumab 60mg (Prolia): should not be used in patients under 18 years due to the risk of serious hypercalcaemia
Link  LSCMMG: Denosumab 60mg injection (Prolia®) shared care guideline
Link  LSCMMG: Denosumab as a second line treatment option for the prevention of osteoporotic fragility fractures position statement
Link  MHRA Drug Safety Update Aug 2020: Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment
Link  MHRA Drug Safety Update June 2017: Denosumab (Prolia, Xgeva): reports of osteonecrosis of the external auditory canal
Link  MHRA safety update Dec 2014:Rare cases of atypical femoral fracture with long-term use
Link  MHRA: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
Link  MHRA: Denosumab: updated recommendations
Link  NICE TA204: Osteoporotic fractures - denosumab

Amber 1 View adult BNF  View SPC online  View childrens BNF
Denosumab XGEVA®
Formulary

Injection 120mg vial

Injection 120mg/ml pre-filled syringe

Commissioning arrangements for the supply and administration of denosumab 120mg by Primary Care have been reviewed. LSCMMG have decided to revert to a Red RAG status. However, primary care prescribers should continue to supply denosumab 120mg for existing patients until further local guidance is made available.

Link  MHRA Drug Safety Update June 2017: Denosumab (Prolia, Xgeva): reports of osteonecrosis of the external auditory canal
Link  MHRA Drug Safety Update June 2018: Denosumab (Xgeva) for advanced malignancies involving bone: study data show new primary malignancies reported more frequently compared to zoledronate
Link  MHRA Drug Safety Update June 2018: Denosumab (Xgeva) for giant cell tumour of bone: risk of clinically significant hypercalcaemia following discontinuation
Link  MHRA: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
Link  MHRA: Denosumab: updated recommendations
Link  NICE TA265: Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours

Red View adult BNF  View SPC online  View childrens BNF