Source: FDA, National Drug Code (US) Revision Year: 2020
TROGARZO is a CD4-directed post-attachment HIV-1 inhibitor.
Ibalizumab-uiyk is a CD4 domain 2-directed humanized monoclonal antibody of immunoglobulin G (IgG) isotype 4 with a molecular weight of approximately 150 kDa. Ibalizumab-uiyk is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells.
TROGARZO Injection is a sterile, colorless to slightly yellow and clear to slightly opalescent solution with no visible particles in a single-dose vial for intravenous infusion. Each single-dose vial delivers approximately 1.33 mL containing 200 mg of ibalizumab-uiyk, and contains the following inactive ingredients: 10 mM L-histidine (2.06 mg), 0.045% polysorbate 80 (0.60 mg), 52 mM sodium chloride (4.04 mg) and 5.2% sucrose (69.2 mg). TROGARZO solution has a pH of 6.0 and contains no preservative.
| Dosage Forms and Strengths |
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Injection: 200 mg/1.33 mL (150 mg/mL) colorless to slightly yellow and clear to slightly opalescent solution with no visible particles in a single-dose vial. |
| How Supplied |
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TROGARZO (ibalizumab-uiyk) injection is a sterile colorless to slightly yellow and clear to slightly opalescent solution with no visible particles for intravenous infusion. It is packaged in a single-dose 2 mL clear glass vial containing 200 mg/1.33 mL (150 mg/mL) of ibalizumab-uiyk. TROGARZO is available in a carton containing two single-dose vials (NDC 62064-122-02). |
| Drug | Countries | |
|---|---|---|
| TROGARZO | Austria, Estonia, Ireland, Israel, Lithuania, Poland, United States |
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