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helps prevent skeletal-related events (SREs) in adult patients with bone metastases from solid tumours.
XGEVA® is for prevention of skeletal-related events (SREs) including pathological fracture, radiation to bone, spinal cord compression or surgery to bone in adult patients with bone metastases from solid tumours.[SmPC, p. 2]
XGEVA® is also used to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.[SmPC, p. 2]
XGEVA® prevents the RANK/RANKL interaction, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and increasing bone mass and strength.[CHMP AR, p. 42]
XGEVA® is provided as a sterile, preservative-free solution, to be administered as a subcutaneous injection every four weeks.[CHMP AR, p. 8; SmPC, p.2]
The safety profile of XGEVA® has been studied extensively in a number of clinical studies.[SmPC, p. 6]
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XGEVA® treatment is superior to therapy with zoledronic acid in the delay or prevention of skeletal-related events (SREs) in adults with bone metastases from breast and castration-resistant prostate cancer. It has similar efficacy to zoledronic acid in adult patients with bone metastases from other solid tumours.[CHMP AR, p. 58] XGEVA® is also used to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.[SmPC, p. 2]
XGEVA® is an alternative to bisphosphonate therapy for preventing skeletal-related events (SREs) in adults with bone metastases from solid tumours.[SmPC, p. 2; CHMP AR, p. 6]
