Source: FDA, National Drug Code (US) Revision Year: 2017
Necitumumab is an anti-EGFR recombinant human monoclonal antibody of the IgG1 kappa isotype that specifically binds to the ligand binding site of the human EGFR. Necitumumab has an approximate molecular weight of 144.8 kDa. Necitumumab is produced in genetically engineered mammalian NS0 cells.
PORTRAZZA is a sterile, preservative free, clear to slightly opalescent and colorless to slightly yellow solution. PORTRAZZA is available in single-dose vials for intravenous infusion following dilution. Each vial contains 800 mg PORTRAZZA in 50 mL (16 mg/mL).
Each mL contains necitumumab (16 mg), citric acid anhydrous (0.256 mg), glycine (9.984 mg), mannitol (9.109 mg), polysorbate 80 (0.1 mg), sodium chloride (2.338 mg), sodium citrate dihydrate (2.55 mg), and water for injection, pH 6.0.
| Dosage Forms and Strengths |
|---|
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Injection: 800 mg/50 mL (16 mg/mL) solution in a single-dose vial. |
| How Supplied |
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PORTRAZZA is supplied in single-dose vials as a sterile, preservative-free solution:
Eli Lilly and Company, Indianapolis, IN 46285 Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA |
| Drug | Countries | |
|---|---|---|
| PORTRAZZA | Austria, Estonia, Ireland, Japan, Lithuania, Poland, Singapore, United States |
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