Lancashire and South Cumbria
Formulary
 
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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 as a second line treatment option for the prevention of osteoporotic fragility fractures position statement
Link  LSCMMG: Shared care guideline (Denosumab 60mg injection (Prolia®))
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

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Denosumab XGEVA®
Formulary

Injection 120mg vial

Injection 120mg/ml pre-filled syringe
Link  LSCMMG: Shared care guideline (Denosumab 120mg injection (Xgeva®))
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

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