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 Formulary Chapter 6: Endocrine system - Full Chapter
06.06.02  Expand sub section  Bisphosphonates and other drugs affecting bone metabolism
06.06.02  Expand sub section  Bisphosphonates
Alendronic acid 
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Formulary
Green

Alendronic acid Tablets 10mg
Alendronic acid Tablets 70mg 
Alendronic acid Oral Solution 70mg/100ml SF
Alendronic acid Effervescent Tablets 70mg

1st line for Osteoporosis

If a liquid formulation is required, the effervescent tablets are preferred over the oral solution. (Applicable in Primary care)

MHRA/CHM advice: Bisphosphonates: atypical femoral fractures (June 2011)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the jaw (November 2009) and Intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the external auditory canal (December 2015)

 
Link  NICE CG146: Osteoporosis: assessing the risk of fragility fracture
Link  NICE QS149: Osteoporosis
Link  NICE TA464: Bisphosphonates for treating osteoporosis
   
Risedronate 
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Formulary
Green

Risedronate Tablets 5mg
Risedronate Tablets 30mg
Risedronate Tablets 35mg

2nd line for Osteoporosis and Paget’s disease

MHRA/CHM advice: Bisphosphonates: atypical femoral fractures (June 2011)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the jaw (November 2009) and Intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the external auditory canal (December 2015)

 
Link  NICE CG146: Osteoporosis: assessing the risk of fragility fracture
Link  NICE QS149: Osteoporosis
Link  NICE TA464: Bisphosphonates for treating osteoporosis
   
Denosumab 
(Prescribe by brand)
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Formulary
Red
High Cost Medicine
NHS England

Xgeva, 70mg/ml 1.7ml Vial
Prolia, 60mg/ml Prefilled Syringe

Restriction: In line with NICE Guidance only

  • Prolia: Use in accordance with NICE TA204 [Oct 2010] when oral bisphosphonates cannot be used. 
  • Xgeva: This presentation is indicated for reduction of bone damage in patients with bone metastases from breast and solid tumours (other than prostate cancer) in line with NICE TA265 [Oct 2012].

Supplementation of at least calcium 500 mg and Vitamin D 400 units daily should also be taken unless hypercalcaemia is present.

MHRA/CHM advice: Denosumab: atypical femoral fractures (February 2013)

MHRA/CHM advice: Denosumab: minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia—updated recommendations (September 2014) and Denosumab: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

MHRA/CHM advice: Denosumab: reports of osteonecrosis of the external auditory canal (June 2017)

MHRA/CHM advice: Denosumab (Xgeva®) for giant cell tumour of bone: risk of clinically significant hypercalcaemia following discontinuation (June 2018)

MHRA/CHM advice: Denosumab (Xgeva®) for advanced malignancies involving bone: study data show new primary malignancies reported more frequently compared to zoledronic acid (zoledronate) (June 2018)

 
Link  NICE TA204: Denosumab for the prevention of osteoporotic fractures in postmenopausal women
Link  NICE TA265: Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours
   
Ibandronic acid 
(oral )
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Formulary
Green

Ibandronic acid Tablets 150mg

Restriction: In line with NICE Guidance only

MHRA/CHM advice: Bisphosphonates: atypical femoral fractures (June 2011)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the jaw (November 2009) and Intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the external auditory canal (December 2015)

 

 
Link  NICE TA464: Bisphosphonates for treating osteoporosis
   
Ibandronic acid 
(oral )
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Formulary
Green

Ibandronic acid Tablets 50mg

Restriction: For the prevention of skeletal events in breast cancer and metastatic bone disease only

MHRA/CHM advice: Bisphosphonates: atypical femoral fractures (June 2011)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the jaw (November 2009) and Intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the external auditory canal (December 2015)

 
   
Ibandronic acid  (Bondronat)
(IV)
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Formulary
Red

3mg/3ml Solution for Injection Pre-filled Syringes
2mg/2ml Concentrate for Solution for Infusion Vials
6mg/6ml Concentrate for Solution for Infusion Vials

Restriction: In line with NICE Guidance only

MHRA/CHM advice: Bisphosphonates: atypical femoral fractures (June 2011)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the jaw (November 2009) and Intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the external auditory canal (December 2015)

 
Link  NICE TA464: Bisphosphonates for treating osteoporosis
   
Sodium Clodronate 
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Formulary
Amber

Sodium Clodronate Tablets 520mg
Sodium Clodronate Tablets 800mg 

Restriction: Initiation under direction of oncology/haematology only

For osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in breast cancer multiple myeloma.

MHRA/CHM advice: Bisphosphonates: atypical femoral fractures (June 2011)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the jaw (November 2009) and Intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the external auditory canal (December 2015)

 

 
   
Disodium pamidronate

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Formulary
Red

15mg/1ml Solution for Infusion Amps
30mg/2ml Solution for Infusion Amps
60mg/4ml Solution for Infusion Amps
90mg/6ml Solution for Infusion Amps

For Osteolytic lesions and bone pain in bone metastases associated with breast cancer or multiple myeloma, and hypercalcemia of malignancy.

MHRA/CHM advice: Bisphosphonates: atypical femoral fractures (June 2011)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the jaw (November 2009) and Intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the external auditory canal (December 2015)

 
   
Zoledronic acid (Aclasta)
(IV)
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Formulary
Red

5mg/100ml solution for infusion

Restriction: In line with NICE Guidance only

  • For Treatment of postmenopausal osteoporosis and osteoporosis in men (including corticosteroid-induced osteoporosis) in those for whom oral treatment options for osteoporosis are inappropriate and when initiated by a specialist. ONCE yearly administration.  Before first infusion give 50 000–125 000 units of vitamin D.

 

  • Also in treatment of Paget's disease of bone (at least 500 mg elemental calcium twice daily (with vitamin D) for at least 10 days is recommended following infusion).

MHRA/CHM advice: Bisphosphonates: atypical femoral fractures (June 2011)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the jaw (November 2009) and Intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the external auditory canal (December 2015)

 
Link  NICE TA464: Bisphosphonates for treating osteoporosis
   
Zoledronic acid  (Zometa)
(IV)
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Formulary
Red

4mg/100ml Solution for infusion Vials

Restriction: For prevention of skeletal related events in adult patients with Myeloma

  • Reduction of bone damage in advanced malignancies involving bone (calcium 500 mg daily and vitamin D 400 units daily should also be taken).
  • Hypercalcaemia of malignancy

MHRA/CHM advice: Bisphosphonates: atypical femoral fractures (June 2011)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the jaw (November 2009) and Intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015)

MHRA/CHM advice: Bisphosphonates: osteonecrosis of the external auditory canal (December 2015)

 
   
06.06.02  Expand sub section  Denosumab
06.06.02  Expand sub section  Strontium renelate
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG
Blueteq
High Cost Drug Approval System

Traffic Light Status Information

Status Description

Red

Medicines that can only be prescribed within Secondary Care. Examples of medicines which fall into this category are: Certain new medicines and new indications for older medicines where there is at present no experience of use in Primary Care. Medicines or dressings not available or prescribable in Primary Care. Where a medicine has been classified as Amber E, but an approved shared-care guideline is not yet available   

Amber

Medicines which can be prescribed within Secondary Care, but are only suitable for prescribing in Primary Care after specialist referral. There is no need for approved shared care guidelines for medicines in this category. This replaces Amber 2 on the North Staffs Formulary.   

Amber E

Medicines which can be prescribed within Secondary Care, but are only considered suitable for prescribing in Primary Care under an approved shared-care agreement (ESCA) or Rationale for Initiation, Continuation and Discontinuation (RICaD). This replaces Amber 1 on the North Staffs Formulary  

Green

Medicines which can be prescribed in either Primary or Secondary Care.  

Grey

These medicines have been reviewed by the New Medicines Committee and the Area Prescribing Committee and found not to be suitable for inclusion in the Joint Formulary. Inadequate or weak evidence for efficacy No clearly defined local need Lack of long term safety data No perceived benefit over established formulary alternatives Prescribers can consider these medicines where formulary alternatives are unsuitable, ineffective or not tolerated.  

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