Active Ingredient: Denosumab
Treatment of 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 120 milligrams denosumab, 1 one dose, over the duration of 7 days. Afterwards, subcutaneous, 120 milligrams denosumab, 1 one dose, over the duration of 7 days. Afterwards, subcutaneous, 120 milligrams denosumab, 1 one dose, over the duration of 2 weeks. Afterwards, subcutaneous, 120 milligrams denosumab, once every 4 weeks.
The recommended dose of denosumab is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy.
Patients in the phase II study who underwent complete resection of giant cell tumour of bone did receive an additional 6 months of treatment following the surgery as per study protocol.
Patients with giant cell tumour of bone should be evaluated at regular intervals to determine whether they continue to benefit from treatment. In patients whose disease is controlled by denosumab, the effect of interruption or cessation of treatment has not been evaluated, however limited data in these patients does not indicate a rebound effect upon cessation of treatment.
Treatment of skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity: the posology is the same as in adults.
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