Source: FDA, National Drug Code (US) Revision Year: 2023
Retifanlimab-dlwr is a programmed death receptor-1 (PD-1)–blocking antibody. Retifanlimab‑dlwr is a humanized IgG4 kappa monoclonal antibody produced in Chinese hamster ovary cells. Retifanlimab-dlwr has an approximate molecular weight of 148 kDa.
ZYNYZ (retifanlimab-dlwr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for intravenous use. The solution is free from visible particles.
Each single-dose vial contains 500 mg of retifanlimab-dlwr in 20 mL of solution. Each mL contains 25 mg of retifanlimab-dlwr, glacial acetic acid (0.18 mg), polysorbate 80 (0.1 mg), sodium acetate (0.57 mg), sucrose (90 mg), and Water for Injection, USP. The pH is 5.1.
| Dosage Forms and Strengths |
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Injection: 500 mg/20 mL (25 mg/mL), clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial. |
| How Supplied |
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ZYNYZ (retifanlimab-dlwr) injection is a clear to slightly opalescent, colorless to pale yellow solution. It is supplied in a carton containing one single-dose vial of:
Manufactured by: Incyte Corporation, Wilmington, DE 19803 |
| Drug | Countries | |
|---|---|---|
| ZYNYZ | Lithuania, United States |
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