Source: FDA, National Drug Code (US) Revision Year: 2023
Rozanolixizumab-noli, a neonatal Fc receptor blocker, is a recombinant, humanized IgG4P monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary DG44 cell line. Rozanolixizumab-noli has an approximate molecular weight of 148 kDa.
RYSTIGGO (rozanolixizumab-noli) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish yellow solution for subcutaneous infusion at a concentration of 140 mg/mL. Each 2 mL single-dose vial contains 280 mg of rozanolixizumab-noli, histidine (2.10 mg), L-histidine hydrochloride monohydrate (9.74 mg), proline (57.56 mg), polysorbate 80 (0.60 mg), and water for injection, USP with a pH of 5.6.
| Dosage Forms and Strengths |
|---|
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Injection: 280 mg/2 mL (140 mg/mL) as a clear to slightly opalescent, colorless to pale brownish yellow solution in a single-dose vial. |
| How Supplied |
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RYSTIGGO (rozanolixizumab-noli) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish yellow solution supplied as a:
Manufactured by: UCB, Inc., 1950 Lake Park Drive, Smyrna, GA 30080 |
| Drug | Countries | |
|---|---|---|
| RYSTIGGO | Austria, Estonia, France, Croatia, Lithuania, Romania, United States |
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