XGEVA^® 120 mg solution for injection

Each vial contains 120 mg of denosumab in 1.7 ml of solution (70 mg/ml).

Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.

Excipient with known effects:

Each 1.7 ml of solution contains 78 mg sorbitol (E420).

For the full list of excipients, see section 6.1.

Solution for injection (injection).

Clear, colourless to slightly yellow solution and may contain trace amounts of translucent to white proteinaceous particles.

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours.

Treatment of adults and skeletally mature adolescents with giant cell tumour o