SPL Set ID: 815d3ba4-27a1-4a06-925a-a87f35442bdb

Denosumab-qbde is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-qbde has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Enoby (denosumab-qbde) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL single-dose prefilled syringe contains 60 mg denosumab-qbde (60 mg/mL solution), glacial acetic acid (1.0809 mg), polysorbate 20 (0.10 mg), sorbitol (46.0 mg), Water for Injection (USP). Sodium hydroxide may be added to adjust pH to approximately 5.2.