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Microsoft word - denosumab shared care guidelines.doc
Shared Care Guideline
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
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.
No specific disease monitoring required. Refer to HDFT
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
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