| Formulary Chapter 6: Endocrine system - Full Chapter
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| 06.06.02 |
Bisphosphonates and other drugs affecting bone metabolism |
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Romosozumab  (Evenity®)
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Formulary
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Solution for injection in pre-filled pen 105mg
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 NICE TA791: Romosozumab for treating severe osteoporosis
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| 06.06.02 |
Bisphosphonates |
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Alendronic Acid
(once weekly)
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Formulary
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70mg tablets are once weekly.
First line for osteoporosis.
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MHRA: Bisphosphonates: atypical femoral fractures
MHRA: Bisphosphonates: osteonecrosis of the jaw
MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
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Disodium Pamidronate
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Formulary
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Intravenous infusion 30mg/10mL, 60mg/10mL, 90mg/10mL
First line for osteolytic lesions and bone pain
Treatment option for hypercalcaemia of malignancy
Paget's disease
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MHRA: Bisphosphonates: atypical femoral fractures
MHRA: Bisphosphonates: osteonecrosis of the jaw
MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
MHRA: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
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Ibandronic Acid injection (Bonviva®)
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Formulary
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Injection 3mg/3mL pre-filled syringe
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MHRA: Bisphosphonates: atypical femoral fractures
MHRA: Bisphosphonates: osteonecrosis of the jaw
MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
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Ibandronic Acid Tablets
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Formulary
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Alternative monthly bisphosphonate when alendronic acid is not appropriate.
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MHRA: Bisphosphonates: atypical femoral fractures
MHRA: Bisphosphonates: osteonecrosis of the jaw
MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
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Ibandronic Acid Tablets (Bondronat®)
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Formulary
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(Bondronat®) Tablets 50mg: Oral alternative bisphosphonate for patients with breast cancer
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LSCMMG: Ibandronic acid tablets
MHRA: Bisphosphonates: atypical femoral fractures
MHRA: Bisphosphonates: osteonecrosis of the jaw
MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
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Risedronate
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Formulary
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Second line for osteoporosis.
Alternative weekly preparation when alendronic acid is not appropriate.
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MHRA: Bisphosphonates: atypical femoral fractures
MHRA: Bisphosphonates: osteonecrosis of the jaw
MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
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Sodium Clodronate
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Formulary
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Capsules 400mg
Tablets 800mg
Oral alternative for patients with multiple myeloma
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MHRA: Bisphosphonates: atypical femoral fractures
MHRA: Bisphosphonates: osteonecrosis of the jaw
MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
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Zoledronic Acid
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Formulary
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(Aclasta®) Specialist use in osteoporosis
Second choice treatment in Paget's disease
(Zometa ®) Second line for osteolytic lesions and bone pain treatment option for hypercalcaemia of malignancy
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MHRA: Bisphosphonates: atypical femoral fractures
MHRA: Bisphosphonates: osteonecrosis of the jaw
MHRA: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
MHRA: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
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Alendronic Acid with colecalciferol (Fosavance)
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Formulary
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| 06.06.02 |
Denosumab |
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Denosumab (Prolia®)
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Formulary
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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
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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
 LSCMMG: Denosumab as a second line treatment option for the prevention of osteoporotic fragility fractures position statement
LSCMMG: Shared care guideline (Denosumab 60mg injection (Prolia®))
MHRA Drug Safety Update Aug 2020: Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment
MHRA Drug Safety Update June 2017: Denosumab (Prolia, Xgeva): reports of osteonecrosis of the external auditory canal
MHRA safety update Dec 2014:Rare cases of atypical femoral fracture with long-term use
MHRA: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
MHRA: Denosumab: updated recommendations
NICE TA204: Osteoporotic fractures - denosumab
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Denosumab (XGEVA®)
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Formulary
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Injection 120mg vial
Injection 120mg/ml pre-filled syringe
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LSCMMG: Shared care guideline (Denosumab 120mg injection (Xgeva®))
MHRA Drug Safety Update June 2017: Denosumab (Prolia, Xgeva): reports of osteonecrosis of the external auditory canal
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
MHRA Drug Safety Update June 2018: Denosumab (Xgeva) for giant cell tumour of bone: risk of clinically significant hypercalcaemia following discontinuation
MHRA: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
MHRA: Denosumab: updated recommendations
NICE TA265: Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours
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| 06.06.02 |
Strontium renelate |
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Strontium Ranelate
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Formulary
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Granules 2g/sachet
Treatment of severe osteoporosis
- in postmenopausal women;
- in 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. In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures.
The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks
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MHRA: Strontium: cardiovascular risk—restricted indication and new monitoring requirements
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Key |
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Restricted Drug |
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Unlicensed |
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
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Scottish Medicines Consortium |
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Cytotoxic Drug |
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Controlled Drug |
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High Cost Medicine |
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Cancer Drugs Fund |
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NHS England |
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Homecare |
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ICB |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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| Status |
Description |
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Green:
Appropriate for initiation and ongoing prescribing in both primary and secondary care.
Generally, little or no routine drug monitoring is required. |
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Green (Restricted):
Appropriate for initiation and ongoing prescribing in both primary and secondary care provided:
Additional criteria specific to the medicine or device are met, or
The medicine or device is used following the failure of other therapies as defined by the relevant LSCMMG pathway.
Generally, little or no routine drug monitoring is required.
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Red medicines:
Medicine is supplied by the hospital for the duration of the treatment course.
Primary care initiation or continuation of treatment is not recommended unless exceptional circumstances such as specialist GP.
Red medicines are those where primary care prescribing is not recommended. These treatments should be initiated by specialists only and prescribing retained within secondary care. They require specialist knowledge, intensive monitoring, specific dose adjustments or further evaluation in use. If however, a primary care prescriber has particular specialist knowledge or experience of prescribing a particular drug for a particular patient it would not always be appropriate for them to expect to transfer that prescribing responsibility back to secondary care. There should be a specific reason and a specific risk agreement, protocol and service set up to support this.
Primary care prescribers may prescribe RED medicines in exceptional circumstances to patients to ensure continuity of supply while arrangements are made to obtain ongoing supplies from secondary care. |
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Amber level 0:
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Little or no specific monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Brief prescribing document or information sheet may be required.
Primary care prescribers must be familiar with the drug to take on prescribing responsibility or must get the required information.
When recommending or handing over care, specialists should ask primary care prescribers to take over prescribing responsibility, and should give enough information about the indication, dose, monitoring requirements, use outside product licence and any necessary dose adjustments to allow them to confidently prescribe. |
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Amber level 1 (with shared care):
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Minimal monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Primary care prescribers are advised not to take on prescribing of these medicines unless they have been adequately informed by letter of their responsibilities with regards monitoring, side effects and interactions and are happy to take on the prescribing responsibility. A copy of locally approved shared care guidelines should accompany this letter which outlines these responsibilities. Primary care prescribers should then tell secondary care of their intentions as soon as possible by letter so that arrangements can be made for the transfer of care. |
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Amber level 2 (with shared care and enhanced service):
Initiated by specialist and transferred to primary care following a successful initiation period.
Significant monitoring required on an on-going basis.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Suitable for enhanced service.
These medicines are considered suitable for GP prescribing following specialist initiation of therapy, as per shared care document which will be sent out with the request to prescribe, with on-going communication between the primary care prescriber and specialist. Amber Level 2 medicines require significant monitoring for which an enhanced service may be suitable. (Subject to local commissioning agreements). |
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Do not prescribe: NOT recommended for use by the NHS in Lancashire and South Cumbria.
Includes medicines that NICE has not recommended for use and terminated technology appraisals, unless there is a local need. |
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Grey medicines:
Medicines which have not yet been reviewed or are under the review process.
GPs and specialists are recommended not to prescribe these drugs.
This category includes drugs where funding has not yet been agreed.
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Refer to local guidance and local commissioning arrangements |
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