Source: FDA, National Drug Code (US) Revision Year: 2024
Denosumab-bbdz is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab-bbdz has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.
Wyost (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 single-dose vial of Wyost contains 120 mg denosumab-bbdz, glacial acetic acid (1.85 mg), polysorbate 20 (0.17 mg), sodium hydroxide (0.91 mg), sorbitol (78.9 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 |
|---|
|
Injection: 120 mg/1.7 mL (70 mg/mL) clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution in a single-dose vial. |
| How Supplied | |||
|---|---|---|---|
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Wyost injection is a clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution supplied in a single-dose vial. The vial stopper is not made with natural rubber latex.
Manufactured by: Sandoz Inc., Princeton, NJ 08540, U.S. License No. 2003 |
| Drug | Countries | |
|---|---|---|
| WYOST | Canada, United States |
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