Leicestershire Health Community
Medicines Formulary
 
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6 Endocrine system
06-06-02 Bisphosphonates and other drugs affecting bone metabolism

Alendronic Acid
First Choice
70mg weekly for Osteoporosis.
Link  MHRA Advice: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
Link  NICE TA 464: Bisphosphonates for treating osteoporosis
 

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Risedronate Sodium
Second Choice
Daily (5mg) or weekly (35mg) for Osteoporosis.
If intolerant or unable to comply with alendronic acid (as per NICE recommendations)
Due to lower incidence of gastric side effects should be used in preference to alendronic acid for those with a history of peptic ulceration.
Also available for treatment of Paget’s disease.
Link  MHRA Advice: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
 

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Alendronic Acid effervescent tablet Binosto®
Restricted
Osteoporosis treatment only for patients who cannot swallow alendronic acid tablets. Not for use in patients with a feeding tube

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Denosumab Prolia®
Restricted
Prescribe in line with NICE TA 204 only
Link  MHRA Advice: Denosumab (Xgeva®▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw-further measures to minimise risk
Link  MHRA Advice: Denosumab 60mg (Prolia▼): rare cases of atypical femoral fracture with long-term use
Link  MHRA Advice: Denosumab: minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia—updated recommendations
Link  NICE TA 204: Denosumab for the prevention of osteoporotic fractures in postmenopausal women
Link  SCA: Denosumab (Prolia®) for post-menopausal osteoporosis
 

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Denosumab Xgeva®
Restricted
Prescribe in line with NICE TA 265 only

Date of entry of decision to Formulary: January 2013
Link  NICE TA 265: Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours
Link  SCA: Denosumab (Xgeva)
Link  MHRA advice: Denosumab (Xgeva▼) for advanced malignancies involving bone: study data show new primary malignancies reported more frequently compared to zoledronate
Link  MHRA advice: Denosumab (Xgeva▼) for giant cell tumour of bone: risk of clinically significant hypercalcaemia following discontinuation
Link  MHRA Advice: Denosumab (Xgeva®▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw-further measures to minimise risk
Link  MHRA Advice: Denosumab: minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia—updated recommendations
 

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Ibandronic Acid - Oral ibandronate
Restricted
Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer as per NICE CG80
Link  NICE CG 80: Early and locally advanced breast cancer: diagnosis and treatment
 

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Teriparatide
Restricted

For use in women in line with NICE guidance only for 18 months treatment

NHSE commisioned for use in men in line with NHSE commissioning policy 170064P only

Link  NICE TA 161: Osteoporosis
 

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Zoledronic Acid Aclasta®
Restricted
Link  IV Zoledronic Acid Patient Selection Criteria.
Link  Leicestershire Evaluation: Zoledronic acid in Osteoporosis
 

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Raloxifene
Restricted

For secondary prevention of osteoporotic fragility in menopausal women.
For use in line with NICE TA 161

Link  NICE TA 161: Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women
 

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Ibandronic acid
Restricted

Unlicensed indication
Use in line with NICE ES 15 for prevention of metastases in early breast cancer patients.

Link  NICE ES 15: Early breast cancer (preventing recurrence and improving survival): adjuvant bisphosphonates
 

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Raloxifene
Non Formulary

Not recommended by NICE for primary prevention of osteoporotic fragility in menopausal women.

Link  NICE TA160: Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women
 

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Strontium Ranelate
Non Formulary

Strontium has been withdrawn by the manufacturer 

Link  MHRA Advice: Strontium ranelate: cardiovascular risk—restricted indication and new monitoring requirements.
 

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