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Bedfordshire and Luton Joint Formulary
Bedfordshire Hospitals NHS Foundation Trust
Bedfordshire, Luton and Milton Keynes ICB
Formulary Chapter: 6 - Endocrine system 
Notes:

Any drug not listed on the Formulary should be considered Non-Formulary - Not recommended for prescribing
06.06.02 Bisphosphonates and other drugs affecting bone metabolism
BLMK Osteoporosis Guideline NICE TA160: Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women NICE TA161: Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women NICE TA464: Bisphosphonates for treating osteoporosis
06.06.02 Bisphosphonates
06.06.02 Denosumab
BLMK Osteoporosis Guideline NICE TA160: Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women NICE TA161: Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women NICE TA464: Bisphosphonates for treating osteoporosis

Denosumab 120mg (XGEVA®)
(Injection)

RED
Restricted Drug Restricted

To be prescribed according to NICE TA265.

Monitor patients for signs and symptoms of hypercalcaemia after discontinuation of denosumab treatment for giant cell tumour of bone. Cases of rebound hypercalcemia have been reported up to 9 months after cessation of treatment.

BNF BNFc SPC
MHRA Drug Safety Update (July 2015) - Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk MHRA DSU (June 18): Denosumab (Xgeva▼) for advanced malignancies involving bone: study data show new primary malignancies reported more frequently compared to zoledronate MHRA DSU (June 18): Denosumab (Xgeva▼) for giant cell tumour of bone: risk of clinically significant hypercalcaemia following discontinuation MHRA DSU June 2017: Denosumab (Prolia, Xgeva▼): reports of osteonecrosis of the external auditory canal NICE TA265: Bone metastases from solid tumours - denosumab

Denosumab 60mg/1mL (Prolia®)
(Injection, pre-filled syringe)

Amber SPA
Restricted Drug Restricted

3rd Choice after alendronate and risedronate (or zoledronic acid) for primary and secondary prevention of osteoporosis in-line with NICE TA204.
The initial dose is to be prescribed and administered in secondary
care, subsequent doses to be prescribed and administered in the primary care setting.
NOTE: Prolia® is administered every six months

 

Amber SCG For The Treatment Of Osteoporosis In PostMenopausal Women And Adult Males (≥ 50 years) At Increased Risk Of Fractures - See Shared Care Guidance

 

Entry reviewed: September 2022

BNF BNFc SPC
MHRA Drug Safety Update (July 2015) - Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk 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 MHRA Drug Safety Update June 2017: Denosumab (Prolia, Xgeva▼): reports of osteonecrosis of the external auditory canal MHRA Drug Safety Update: Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment (August 2020) MHRA Drug Saftey Update (October 2012) - Denosumab: monitoring recommended NICE TA204: Osteoporotic fractures - denosumab
06.06.02 Strontium renelate
Classifications
GREEN
May be initiated in any care setting
Amber SPA
Specialist to advise therapy and provide first 28 days supply, continuation in Primary Care
Amber SPIS
Specialist to initiate and stabilise medicine prior to continuation in Primary Care
SCG
To be prescribed as per Shared Care Guidance. If no SCG in place status reverts to red.
RED
Red medicines are designated as specialist only medicines which should only be prescribed by a specialist, usually within secondary care (either due to the requirement for specialist knowledge, long-term monitoring requirements, or restrictions that mean medicine supplies are only available to hospitals).
DNP
A decision has been made either locally and/or nationally not to routinely commission this preparation. Do not prescribe.
SELF
To be purchased over the counter. May be prescribed for chronic, long term conditions or on admission to hospital if essential.