SPL Set ID: 8aefc8e3-26d6-4ff6-aab9-a7542927e084

Efgartigimod alfa-fcab is a human immunoglobulin G1 (IgG1) -derived Fc fragment (fragment, crystallized) of the za allotype. The efgartigimod alfa-fcab Fc fragment is a homodimer consisting of two identical peptide chains each consisting of 227 amino acids linked together by two interchain disulfide bonds with affinity for FcRn. The molecular weight of efgartigimod alfa-fcab is approximately 54 kDa. VYVGART (efgartigimod alfa-fcab) injection is a sterile, preservative free, clear to slightly opalescent, colorless to slightly yellow solution supplied in a single-dose vial for infusion after dilution. Each 20 mL single-dose vial contains 400 mg of efgartigimod alfa-fcab at a concentration of 20 mg/mL. In addition, each mL of solution contains arginine hydrochloride (10.5 mg), histidine (1.4 mg), L- histidine hydrochloride monohydrate (2.2 mg), methionine (1.5 mg), polysorbate 80 (0.4 mg), sodium chloride (4.1 mg), sucrose (20.5 mg), and Water for Injection, USP, at a pH of 6.0.