Microsoft word - denosumab shared care guidelines.doc

Shared Care Guideline
Denosumab
Treatment of osteoporosis in post menopausal women
This shared care agreement outlines the responsibilities between the specialist and the generalist for managing the prescribing of denosumab for indications listed below. 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 • who have a combination of T-score, age and number of independent clinical risk factors for fracture as indicated in the following table. Numbers of independent clinical risk factors 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. 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 Hypersensitivity to the active substance or to any of the The needle cover for the prefilled syringe contains natural dry rubber (derivative of latex) which may cause allergic reactions 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 HDFT policy is to prescribe denosumab according to the NICE guidance and Harrogate and District NHS Foundation Trust 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- 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.  Assess the suitability of the patient for treatment.  Confirm absence of any contra indication to denosumab  Inform patient of side effects of denosumab and obtain  Provide advice to patient as set out below Baseline tests prior to initiation and communication of  Ask the GP whether they are willing to participate in  Ensure patient is co-prescribed calcium and vitamin D if  As with bisphosphonates assess oral hygiene and use clinical judgment as to if a dental examination is  Initiate treatment by prescribing and administering first  Make decision whether to continue denosumab  Provide continuing clinical support to the patient and  Review therapy in 4 years and communicate decision to 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 Monitoring of calcium levels is recommended for those patients predisposed to hypocalcaemia. Highest risk of hypocalcaemia is if GFR <30ml/min (including dialysis patients), monitor calcium levels about 10 days after initial injection. Specific information for patients
Patients should be informed to report any of the following symptoms to their GP without delay  New or unusual thigh, hip, or groin pain Patients should be informed that they are responsible for booking and attending appointments to have denosumab. Disease monitoring
No specific disease monitoring required. Refer to HDFT
Osteoporosis Guidelines.
 Reply to the request for shared care as soon as  Prescribe denosumab as recommended by the  Ensure a way of supplying and administering subsequent doses of denosumab are in place. Denosumab should be stored in a fridge prior to administration.  Add denosumab to patients medication list on practice computer system to allow accurate medicines reconciliation if admitted to hospital.  Ensure patient is co-prescribed calcium and vitamin D if  Monitor for adverse effects of denosumab and stop treatment and inform specialist if necessary.  Report adverse effects to the specialist and where appropriate the Commission on Human Medicines/MHRA (Yellow card scheme)
Monitoring by GP

There are no regular specific monitoring requirements.
Monitoring of calcium levels is recommended for those patients
predisposed to hypocalcaemia. Highest risk of hypocalcaemia
is if GFR <30ml/min (including dialysis patients), monitor
calcium levels about 10 days after injection. It is recommended that the same practice should be used when reviewing patients on denosumab as on bisphosphonates. GP should monitor for injection site infections and manage as appropriate Monitoring of osteonecrosis of the jaw such as patient presenting with jaw pain. If presents denosumab should be stopped and hospital specialist contacted. Patients presenting with unusual pain in the thigh, hip or groin should be evaluated for an incomplete femoral fracture. Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur. Discontinuation of denosumab therapy should be considered if an atypical femur fracture is suspected, while the patient is evaluated Hospital Specialist to GP
The hospital specialist will ensure that arrangements are in place for GPs to obtain advice and support where needed. The hospital specialist will send a copy of the shared care The hospital specialist will inform the GP when they have initiated or stopped denosumab. GP to Hospital Specialist
If the GP has concerns over the prescribing of denosumab they will contact the hospital specialist as soon as possible. The GP will inform the hospital specialist if denosumab has Available via hospital switchboard 01423 885959  British National Formulary 65 March 2013 Summary of Product Characteristics www.medicines.org.uk Accessed 24/4/13  HDFT Osteoporosis Guidelines  MHRA Drug Safety Update Volume 6 issue 3 October  MHRA Drug Safety Update Volume 6 issue 7 February  NICE Guidance Osteoporotic fractures-denosumab (TA204) October 2010 Accessed via www.nice.org.uk 26/4/13

Source: http://www.harrogateformulary.nhs.uk/docs/sc/Denosumab_SharedCareGuidelines.pdf