| Formulary Chapter 6: Endocrine system - Full Chapter
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| Chapter Links... |
 NTAG Endocrine System Recommendations |
| Details... |
| 06.06.02 |
Bisphosphonates and other drugs affecting bone metabolism |
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Burosumab (Crysvita®)
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Formulary
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- 10mg, 20mg & 30mg solution for injection
- Approved for treating X-linked hypophosphataemia in children and young people in accordance with NICE
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NICE HST 8: Burosumab for treating X-linked hypophosphataemia in children and young people
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Bisphosphonates |
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Alendronic Acid
(osteoporosis)
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First Choice
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- 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
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NICE TA464 Bisphosphonates for treating osteoporosis
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Disodium Pamidronate 30mg injection
(hypercalcaemia)
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Formulary
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Ibandronic Acid
(osteoporosis)
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Alternatives
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- 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).
- Ibandronic acid 150mg tablets are approved for the treatment of osteoporosis in line with NICE
- 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)
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NICE TA464 Bisphosphonates for treating osteoporosis
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Risedronate
(Osteoporosis/Paget's)
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Alternatives
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- 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
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NICE TA464 Bisphosphonates for treating osteoporosis
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Sodium Clodronate
(Hypercalcaemia)
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Alternatives
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Zoledronic Acid 4mg injection
(Hypercalcaemia/breast cancer)
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Alternatives
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- 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®
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Zoledronic Acid 5mg injection
(Osteoporosis/Paget's)
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Alternatives
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- Prescribe by brand name
- Approved for the treatment of osteoporosis in line with NICE
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NICE TA464 Bisphosphonates for treating osteoporosis
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| 06.06.02 |
Denosumab |
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Denosumab (Xgeva®)
(Metastases)
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Formulary
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- 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
- Exisiting patients
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MHRA Drug Safety Updates: Denosumab
NICE TA265: Bone metastases from solid tumours - denosumab: guidance
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Denosumab (Prolia®)
(Osteoporosis)
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Alternatives
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- 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.
- NOTE: Denosumab will remain as in most localities until a shared care guideline has been produced.
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NICE TA204: Osteoporotic fractures - denosumab
MHRA Drug Safety Updates: Denosumab
 North of Tyne, Gateshead and North Cumbria: DENOSUMAB (Prolia®) 60mg sc twice yearly for osteoporosis Information for Treatment of Adults in Primary Care
CD&TV APC Information sheet to support prescribing and monitoring of Denosumab (Prolia®
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| 06.06.02 |
Strontium renelate |
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Strontium Ranelate
(Sachets)
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Formulary
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- 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.
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| 06.06.02 |
Romosozumab |
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Romosozumab (Evenity ®)
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Formulary
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- Approved for severe osteoporosis in people after menopause who are at high risk of fracture in line with NICE.
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NICE TA791: Romosozumab for treating severe osteoporosis
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
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Description |
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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. |
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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. |
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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. |
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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. |
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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. |
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
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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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