Denosumab
Indication
Denosumab for treatment of Glucocorticoid-induced osteoporosis
MHRA Drug Safety Update - Denosumab: updated recommendations
Amber level 1
Brand:
Prolia®
Nice TA:
Commissioning responsibility:
CCG
PbR excluded:
No
BNF chapter:
Endocrine system
Background
Patients with any of the following clinical features would be considered for treatment with denosumab:
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Upper gastrointestinal abnormalities, including oesophageal stricture, achalasia, abnormalities which delay oesophageal emptying, dysphagia, oesophageal disease (oesophagitis, ulcers, erosions), gastritis, duodenitis, gastric ulcers, previous upper GI surgery.
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Inability to sit or stand upright for at least 30 minutes.
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Renal impairment (eGFR 35ml/min). (Denosumab’s SPC states there is no data for patients with eGFR 30ml/min. Many clinicians are happy to use if eGFR > 20ml/min, provided serum calcium is closely monitored after each injection).
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Concerns about compliance with treatment – may include patients with cognitive impairment.
For patients with corticosteroid induced osteoporosis the LSCMMG has agreed that the choice of denosumab or zoledronic acid should be based on the clinical judgement of the responsible clinician.
Recommendation
LSCMMG Recommendation:
Amber level 1
Reason for decision:
Shared care required
Supporting documents: