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Launched in January 2024, IRP aims to further help bring life-saving new medicines to UK patients without delay
Serious and life-threatening hypercalcaemia has been reported with denosumab 60mg (Prolia) in children and adolescents in clinical trials for osteogenesis imperfecta and during off-label use. Denosumab 60mg (Prolia) is authorised for use in adults with osteoporosis and other bone loss...
Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
Rare cases of atypical femoral fracture with long-term use.
Monitor patients for signs and symptoms of hypercalcaemia after discontinuation of denosumab treatment for giant cell tumour of bone. Cases of rebound hypercalcemia have been reported up to 9 months after cessation of treatment.
Evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab 60mg, particularly in those with previous vertebral fracture. Patients should not stop denosumab without specialist review.
Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
Fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment.
A pooled analysis has shown an increased rate of new primary malignancies in patients given Xgeva (1-year cumulative incidence 1.1%) compared with those given zoledronic acid (0.6%), when used in the indication of the prevention of skeletal-related events with advanced...
Zolbetuximab (Vyloy) is a monoclonal antibody that can recognise and attach itself to certain cancer cells to destroy them.
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