Source: FDA, National Drug Code (US) Revision Year: 2024
Denosumab-bbdz is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-bbdz has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.
Jubbonti (denosumab-bbdz) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution for subcutaneous use.
Each 1 mL single-dose prefilled syringe of Jubbonti contains 60 mg denosumab-bbdz (60 mg/mL solution), glacial acetic acid (1.021 mg), polysorbate 20 (0.1 mg), sodium hydroxide (0.499 mg), sorbitol (47 mg), and Water for Injection (USP) with a pH of 5.2. Hydrochloric acid and sodium hydroxide may be added to adjust pH.
| Dosage Forms and Strengths |
|---|
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Injection: 1 mL of a 60 mg/mL clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution in a single-dose prefilled syringe. |
| How Supplied | |||
|---|---|---|---|
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Jubbonti injection is a clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution supplied in a single-dose prefilled syringe with a 29 gauge ½ inch needle with a BD UltraSafe PlusTM Passive Safety Guard. The prefilled syringe with safety guard is not made with natural rubber latex.
Manufactured by: Sandoz Inc., Princeton, NJ 08540, U.S. License No. 2003 |
| Drug | Countries | |
|---|---|---|
| JUBBONTI | Canada, Lithuania, United States |
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