Denosumab-qbde

FDA Drug Profile — XTRENBO, ENOBY

Drug Details

Generic Name
Denosumab-qbde
Brand Names
XTRENBO, ENOBY
Application Number
BLA761439
Sponsor
Hikma Pharmaceuticals USA Inc.
NDC Codes
2
Dosage Forms
INJECTION
Routes
SUBCUTANEOUS
Active Ingredients
DENOSUMAB

Indications and Usage

1 INDICATIONS AND USAGE Xtrenbo 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 Xtrenbo 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 Xtrenbo 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 Xtrenbo is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.