Source: FDA, National Drug Code (US) Revision Year: 2020
Emapalumab-lzsg is an interferon gamma (IFNγ) blocking antibody. Emapalumab-lzsg is produced in Chinese Hamster Ovary cells by recombinant DNA technology. Emapalumab-lzsg is an IgG1 immunoglobulin with a molecular weight of approximately 148 kDa.
GAMIFANT (emapalumab-lzsg) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution provided in single-dose vials that require dilution prior to intravenous infusion.
Each vial contains 10 mg/2 mL or 50 mg/10 mL emapalumab-lzsg at a concentration of 5 mg/mL. Each mL also contains the following inactive ingredients: L-Histidine (1.55 mg), L-Histidine monohydrochloride, monohydrate (3.14 mg), Polysorbate 80 (0.05 mg), sodium chloride (7.30 mg), and Water for Injection, USP.
| Dosage Forms and Strengths |
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GAMIFANT is a clear to slightly opalescent, colorless to slightly yellow preservative-free solution available as: Injection:
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| How Supplied |
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GAMIFANT (emapalumab-lzsg) injection is a sterile, clear to slightly opalescent, colorless to slightly yellow solution supplied in the following packaging configuration: NDC 72171-501-01 – containing one 10 mg/2 mL (5 mg/mL) single-dose vial NDC 72171-505-01 – containing one 50 mg/10 mL (5 mg/mL) single-dose vial |
| Drug | Countries | |
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| GAMIFANT | United States |
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