Denosumab-kyqq

FDA Drug Profile — BOSAYA, AUKELSO

Drug Details

Generic Name
Denosumab-kyqq
Brand Names
BOSAYA, AUKELSO
Application Number
BLA761436
Sponsor
Biocon Biologics Inc.
NDC Codes
2
Dosage Forms
INJECTION
Routes
SUBCUTANEOUS
Active Ingredients
DENOSUMAB

Indications and Usage

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