denosumab

FDA Drug Profile — OSPOMYV, WYOST, XGEVA, Prolia, JUBBONTI

Drug Details

Generic Name
denosumab
Brand Names
OSPOMYV, WYOST, XGEVA, Prolia, JUBBONTI
Application Number
BLA761392
Sponsor
Novartis Pharmaceuticals Corporation
NDC Codes
8
Dosage Forms
LIQUID, INJECTION, SOLUTION, INJECTION
Routes
SUBCUTANEOUS
Active Ingredients
DENOSUMAB, DENOSUMAB-DSSB

Indications and Usage

1 INDICATIONS AND USAGE Bilprevda is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Bilprevda is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Bilprevda is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials ( 14.2 )] . 1.3 Hypercalcemia of Malignancy Bilprevda is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.