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|Shared Care Guideline |

|Denosumab |

|Treatment of osteoporosis in post menopausal women |

| | |

|Introduction |This shared care agreement outlines the responsibilities between the specialist and the |

| |generalist for managing the prescribing of denosumab for indications listed below. |

|Indication |NICE guidance recommends denosumab as a treatment option for the primary prevention of |

| |osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures: |

| |• who are unable to comply with the special instructions for administering alendronate and |

| |either risedronate or etidronate, or have an intolerance of, or a contraindication to, those |

| |treatments and |

| |• who have a combination of T-score, age and |

| |number of independent clinical risk factors for |

| |fracture as indicated in the following table. |

| | |

| |Age (Years) |

| |Numbers of independent clinical risk factors for fracture |

| | |

| | |

| |0 |

| |1 |

| |2 |

| | |

| |65-69 |

| |Not recommended |

| |-4.5 |

| |-4.0 |

| | |

| |70-74 |

| |-4.5 |

| |-4.0 |

| |-3.5 |

| | |

| |75 or older |

| |-4.0 |

| |-4.0 |

| |-3.0 |

| | |

| | |

| |Denosumab is recommended as a treatment option for the secondary prevention of osteoporotic |

| |fragility fractures only in |

| |postmenopausal women at increased risk of fractures who are unable to comply with the special |

| |instructions for administering alendronate and either risedronate or etidronate, or have |

| |an intolerance of, or a contraindication to, those treatments. |

|Licensing information |Denosumab is licensed for the treatment of osteoporosis in postmenopausal women at increased |

| |risk of fractures. |

| | |

| |Denosumab is contraindicated in the following: |

| |Hypocalcaemia - Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D |

| |before initiating therapy. Patients with severe renal impairment (creatinine clearance < 30 |

| |ml/min) or receiving dialysis are at greater risk of developing hypocalcaemia. Clinical |

| |monitoring of calcium levels is recommended for patients predisposed to hypocalcaemia. |

| | |

| |Hypersensitivity to the active substance or to any of the excipients |

| | |

| |The needle cover for the prefilled syringe contains natural dry rubber (derivative of latex) |

| |which may cause allergic reactions |

| | |

| | |

| | |

|Dosage and administration |The recommended dose of denosumab is 60 mg administered as a single subcutaneous injection |

| |once every 6 months into the thigh, abdomen or upper arm. Patients must be adequately |

| |supplemented with calcium and vitamin D. |

| | |

| |No dosage reduction is required in renal or hepatic impairment or in the elderly population. |

| | |

| |HDFT policy is to prescribe denosumab according to the NICE guidance and Harrogate and |

| |District NHS Foundation Trust Osteoporosis Guidelines |

| | |

|Adverse drug reactions |For a comprehensive list of adverse drug reactions consult Summary of Product Characteristics |

| |or BNF |

| | |

| |Constipation, UTI, upper respiratory tract infection, pain in the extremity, sciatica, |

| |cataracts, rash; less commonly-diverticulitis, cellulitis, ear infection, eczema; rarely- |

| |osteonecrosis of the jaw, atypical femoral fractures; very rarely-hypocalcaemia |

| | |

|Drug Interactions |There are no known interactions with denosumab |

| | |

| |Note: This information is not exhaustive and the current BNF/SPC should be referred to for |

| |more information. |

|Duration of Treatment |4 years then review |

|Responsibilities of the |Assess the suitability of the patient for treatment. |

|specialist initiating treatment|Confirm absence of any contra indication to denosumab |

| |Inform patient of side effects of denosumab and obtain informed consent for treatment |

| |Provide advice to patient as set out below |

| |Baseline tests prior to initiation and communication of results to the GP. |

| |Ask the GP whether they are willing to participate in shared care. |

| |Ensure patient is co-prescribed calcium and vitamin D if appropriate |

| |As with bisphosphonates assess oral hygiene and use clinical judgment as to if a dental |

| |examination is required prior to starting therapy. |

| |Initiate treatment by prescribing and administering first dose in secondary care. |

| |Make decision whether to continue denosumab |

| |Provide continuing clinical support to the patient and GP |

| |Review therapy in 4 years and communicate decision to stop or continue with GP |

| |Baseline Tests |

| | |

| |Secondary care specialist will monitor the patient's renal and calcium levels prior to |

| |initiation of denosumab. Secondary care specialist will correct any hypocalcaemia prior to |

| |starting therapy. |

| |Monitoring of calcium levels is recommended for those patients predisposed to hypocalcaemia. |

| |Highest risk of hypocalcaemia is if GFR ................
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