denosumab-bmwo
Drug Details
- Generic Name
- denosumab-bmwo
- Brand Names
- Denosumab-BMWO, Osenvelt, Stoboclo
- Application Number
- BLA761404
- Sponsor
- CELLTRION USA, Inc.
- NDC Codes
- 4
- Dosage Forms
- INJECTION
- Routes
- SUBCUTANEOUS
- Active Ingredients
- DENOSUMAB
Indications and Usage
1 INDICATIONS AND USAGE Denosumab-bmwo 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 Denosumab-bmwo 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 Denosumab-bmwo 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 Denosumab-bmwo is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.