| Formulary Chapter 6: Endocrine system - Full Chapter
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| Notes: |
Where a formulary entry does not detail a medicine’s indications for use, the medicine can be assumed to be approved for all licensed indications.
Formulary approved "off-label" use is detailed separately. |
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| Chapter Links... |
 SE London APC Blood Glucose Control Management Pathway for Adults with Type 2 Diabetes Mellitus (T2DM) |
| Details... |
| 06.06.02 |
Bisphosphonates and other drugs affecting bone metabolism |
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Bisphosphonates |
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Alendronic acid tabs
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First Choice
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 FIRST-LINE ORAL BISPHOSPHONATE
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Disodium etidronate tabs
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Formulary
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Disodium pamidronate injection
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Formulary
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Approved for licensed use, and the following off-label indication:
Non-malignant hypercalcaemia - follow local guidelines
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 MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
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Ibandronic acid injection
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 Restricted
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CONSULTANT SPECIALISTS ONLY
Treatment of osteoporosis in postmenopausal women at increased risk of fracture, who do not tolerate oral bisphosphonates
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MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
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Risedronate tabs
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Formulary
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Risedronate, calcium carbonate and colecalciferol tabs
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Formulary
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Sodium clodronate caps, tabs
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Formulary
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Zoledronic acid injection 4mg (licensed use)
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Restricted
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RESTICTED USE – ONCOLOGY, HAEMATOLOGY & UROLOGY ONLY
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MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
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Zoledronic acid injection 5mg
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Restricted
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CONSULTANT SPECIALISTS ONLY
- Paget’s disease of the bone
- Osteoporosis in post-menopausal women and men at increased risk of fracture
- Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture
- Prevention of osteoporosis associated with long-term high dose systemic glucocorticoid therapy, where oral bisphosphonates are not possible (off-label)
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MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
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Zoledronic acid injection 4mg (Improved outcomes in early stage post-menopausal breast cancer - off-label)
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Restricted
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 Approved off-label indication:
Improved outcomes in early stage post-menopausal breast cancer
Dose = 4mg infusion every 6 months after completion of adjuvant chemotherapy - maximum 5 years treatment
Consultant oncologists only
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MHRA Jul 2015: Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
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| 06.06.02 |
Denosumab |
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| 06.06.02 |
Strontium renelate |
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| Non Formulary Items |
Ibandronic acid tabs
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Non Formulary
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Not approved for use in SE London (all indications) |
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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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Cancer Drugs Fund
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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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Specialist or hospital prescribing only.
The responsibility for prescribing, monitoring, dose adjustment and review should remain with the specialist or hospital.
In very exceptional circumstances a specialist may discuss individual patient need for a RED drug to be prescribed by a GP and the GP should consider informing the Medicines Management team before a decision is made to prescribe for individual patients.
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Treatment can be initiated in primary care after a recommendation from an appropriate specialist |
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Specialist initiation followed by maintenance prescribing in primary care |
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Specialist initiation with ongoing monitoring required. After dose stabilisation GPs can be requested to take over prescribing responsibilities using the approved APC shared care documentation |
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Specialist and non-specialist initiation |
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Not recommended for prescribing |
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