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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...
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.
Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
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...
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.
Rare cases of atypical femoral fracture with long-term use.
Fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment.
Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
Osteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).
Last month, letters were sent regarding SGLT2 inhibitors and Xgeva▼ (denosumab).
Now only authorised for use in patients with symptomatic bone metastases and no known visceral metastases who have had 2 previous systemic treatments for metastatic castration-resistant prostate cancer or who cannot receive other systemic treatments. Do not use in combination...
MV Chinfield antifatigue bronchospasmolytic for thoroughbreds seized at a Belfast courier company.
medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified in this notification due to particles detected during long-term stability tests.
Despicable people who create sexually explicit ‘deepfakes’ will face prosecution under a new law announced by the government today (16 April 2024).
Product Recall for SMART electric height-adjustable mobile stand presenting a risk of injuries.
Check the tariff classification for bones with some meat, fat and tendons (so called soup bones).
Farm Animal Welfare Council advice to government about the extent of hens' bone fractures in all production systems and the impact on welfare.
Product Safety Report for Vixa Skineal Steroid Cream presenting a serious chemical risk.
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