Source: FDA, National Drug Code (US) Revision Year: 2020
Inebilizumab-cdon is a CD19-directed humanized afucosylated IgG1 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight is approximately 149 kDa.
UPLIZNA (inebilizumab-cdon) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, free from visible particles, for intravenous use.
Each single-dose vial contains 100 mg of inebilizumab in 10 mL of solution. Each mL contains 10 mg of inebilizumab-cdon, L-histidine (1.4 mg), L-histidine hydrochloride monohydrate (2.3 mg), polysorbate 80 (0.1 mg), sodium chloride (4.1 mg), α,α-trehalose dihydrate (40.1 mg), and Water for Injection, USP and a pH of 6.
| Dosage Forms and Strengths |
|---|
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Injection: 100 mg/10 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial. |
| How Supplied |
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UPLIZNA (inebilizumab-cdon) injection is a clear to slightly opalescent, colorless to slightly yellow solution supplied as:
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| Drug | Countries | |
|---|---|---|
| UPLIZNA | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Japan, Lithuania, United States |
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