SPL Set ID: 3c0eb8c2-c042-4954-b451-3baa77f5e6d1

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 140 mg/mL (2 mL, 3 mL, 4 mL, and 6 mL vials) RYSTIGGO (rozanolixizumab-noli) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish yellow solution for subcutaneous infusion. Each single-dose vial contains 280 mg, 420 mg, 560 mg, or 840 mg of rozanolixizumab-noli at a concentration of 140 mg/mL with a pH of 5.6. Each mL also contains histidine (1.05 mg), L-histidine hydrochloride monohydrate (4.87 mg), polysorbate 80 (0.30 mg), proline (28.78 mg), and water for injection, USP.