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 Formulary Chapter 6: Endocrine system - Full Chapter
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06.06.02  Expand sub section  Bisphosphonates and other drugs affecting bone metabolism
Burosumab  (Crysvita®)
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Formulary
Red

  • 10mg, 20mg & 30mg solution for injection

  • Approved for treating X-linked hypophosphataemia in children and young people in accordance with NICE

 
Link  NICE HST 8: Burosumab for treating X-linked hypophosphataemia in children and young people
 
06.06.02  Expand sub section  Bisphosphonates
Alendronic Acid
(osteoporosis)
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First Choice
Green
  • Approved alendronic acid formulations include:
    • 10mg tablets (taken daily)
    • 70mg tablets (taken once weekly) – preferred
    • 70mg effervescent tablets (Binosto®) - for use only in patients with documented swallowing difficulties

  • Alendronic acid is approved for the primary prevention of osteoporosis in postmenopausal women in line with NICE
  • Approved for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis primary in line with NICE.
  • Approved for the treatment of osteoporosis in line with NICE
 
Disodium Pamidronate 30mg injection
(hypercalcaemia)
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Formulary
Red
 
 
Ibandronic Acid
(osteoporosis)
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Alternatives

  • Ibandronic acid 50mg tablets are approved for use in the reduction of bone damage in patients with metastatic breast cancer. Not approved for use in the treatment of patients with other forms of cancer (e.g. prostate). Green plus  

  • Ibandronic acid 150mg tablets are approved for the treatment of osteoporosis in line with NICE Green

  • Ibandronic acid 3mg in 3ml injection is approved for use where oral bisphosphonates are not appropriate (not tolerated, contra-indicated because of upper gastro-intestinal problems or insufficiently effective) Red

 
Link  NICE TA464 Bisphosphonates for treating osteoporosis
 
Risedronate
(Osteoporosis/Paget's)
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Alternatives
Green
  • Approved risedronate formulations include:
    • 5mg tablets (taken daily);
    • 35mg tablets (taken once weekly for osteoporosis) -preferred.

  • Risedronate is approved for the primary prevention of osteoporosis in line with NICE, and for for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis in line with NICE. 
  • Risedronate 30mg tablets are also approved for Paget’s disease.
  • Approved for the treatment of osteoporosis in line with NICE
 
Link  NICE TA464 Bisphosphonates for treating osteoporosis
 
Sodium Clodronate
(Hypercalcaemia)
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Alternatives
Green plus
  • 520mg and 800mg tablets
 
 
Zoledronic Acid 4mg injection
(Hypercalcaemia/breast cancer)
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Alternatives
Red
  • Approved for use in treating hypercalcaemia of malignancy and the prevention of skeletal events in patients with metastatic breast cancer.
  • Approved for the adjuvant treatment of post-menopausal  women with early breast cancer (subject to agreement with the CCGs and provider trusts regarding the extra activity). 
  • Not approved for preventing skeletal events in patients with prostate cancer.
  • To avoid confusion it is recommended that this product is prescribed by brand name i.e. Zometa®
 
 
Zoledronic Acid 5mg injection
(Osteoporosis/Paget's)
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Alternatives
Red
  • Prescribe by brand name
  • Approved for the treatment of osteoporosis in line with NICE
 
Link  NICE TA464 Bisphosphonates for treating osteoporosis
 
06.06.02  Expand sub section  Denosumab
Denosumab (Xgeva®)
(Metastases)
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Formulary
Red
  • Denosumab 70mg in 1ml (120mg) vial is approved for the prevention of skeletal-related events in adults with bone metastases from solid tumours in line with NICE 
    • Note: denosumab is not approved for therapy induced bone loss in non- metastatic prostate cancer (NICE).


  • North Cumbria only
    • New patients        Red
    • Exisiting patients  Green plus
 
Link  MHRA Drug Safety Updates: Denosumab
Link  NICE TA265: Bone metastases from solid tumours - denosumab: guidance
 
Denosumab (Prolia®)
(Osteoporosis)
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Alternatives
Amber
  • Denosumab 60mg in 1ml solution in prefilled syringe is approved for use in the treatment of postmenopausal osteoporosis in line with NICE. Also approved for male patients who dont tolerate bisphosphonates or strontium ranelate. 

 

 
Link  NICE TA204: Osteoporotic fractures - denosumab
Link  MHRA Drug Safety Updates: Denosumab
Link  North of Tyne, Gateshead and North Cumbria: DENOSUMAB (Prolia®) 60mg sc twice yearly for osteoporosis Information for Treatment of Adults in Primary Care
Link  CD&TV APC Information sheet to support prescribing and monitoring of Denosumab (Prolia®
 
06.06.02  Expand sub section  Strontium renelate
Strontium Ranelate
(Sachets)
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Formulary
Red

  • Treatment of severe osteoporosis

    • in post menopausal women and adult men at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.



 
 
06.06.02  Expand sub section  Romosozumab to top
RomosozumabBlack Triangle (Evenity ®)
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Formulary
Red
CCG
  • Approved for severe osteoporosis in people after menopause who are at high risk of fracture in line with NICE.
 
Link  NICE TA791: Romosozumab for treating severe osteoporosis
 
 ....
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
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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