Source: FDA, National Drug Code (US) Revision Year: 2023
Margetuximab-cmkb, a HER2/neu receptor antagonist, is a chimeric Fc-engineered IgG1 kappa monoclonal antibody.
Margetuximab-cmkb is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Margetuximab-cmkb has an approximate molecular weight of 149 kDa.
MARGENZA (margetuximab-cmkb) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow or pale brown solution that requires dilution for intravenous use. Some visible, translucent, inherent proteinaceous particles may be present. Each single-dose vial contains 250 mg of margetuximab-cmkb in 10 mL of solution. Each mL of solution contains 25 mg of margetuximab-cmkb, L-arginine hydrochloride (11 mg), polysorbate 80 (0.1 mg), sodium chloride (2.9 mg), sodium phosphate dibasic, heptahydrate (0.58 mg), sodium phosphate monobasic, monohydrate (1.1 mg), sucrose (30 mg), and Water for Injection, USP at a pH of approximately 6.1.
| Dosage Forms and Strengths |
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Injection: 250 mg/10 mL (25 mg/mL) clear to slightly opalescent, colorless to pale yellow or pale brown solution in a single-dose vial. |
| How Supplied | ||||||
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MARGENZA (margetuximab-cmkb) injection is a clear to slightly opalescent, colorless to pale yellow or pale brown solution in a single-dose vial supplied as:
Manufactured by: MacroGenics, Inc., 9704 Medical Center Drive, Rockville, MD 20850-3343 |
| Drug | Countries | |
|---|---|---|
| MARGENZA | Israel, United States |
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