Alternative names |
16C4-aFuc; A-fucosylated anti-CD19 antibody; Anti-CD19 MAb-Viela-Bio; MEDI 551; MT-0551; inebilizumab-cdon; inebilizumab; Uplizna™ |
Class |
Antineoplastics; immunotherapies; monoclonal antibodies; eye disorder therapies; skin disorder therapies |
Mechanism of action |
Antibody-dependent cell cytotoxicity |
Route of administration |
Intravenous |
Pharmacodynamics |
Afucosylated, humanized IgGκ monoclonal antibody directed against B-lymphocyte antigen CD19. Depletes CD19-expressing B cells through antibody-dependent cell cytotoxicity |
Pharmacokinetics |
Cmax 108 μg/mL and 26-week AUC 2980 µg day/mL after second of two 300 mg doses 2 weeks apart; central and peripheral Vd 2.95 L and 2.57 L; degraded by widely distributed proteolytic enzymes; systemic clearance 0.19 L/day; mean t½ 18 days |
Adverse reactions (incidence ≥ 7%) |
Urinary tract infection, arthralgia, infusion reaction, nasopharyngitis, headache, and back pain |
ATC codes |
WHO ATC code |
L01X-C (monoclonal antibodies); L04A (immunosuppressants); N07 (other nervous system drugs); S01X-A (other ophthalmologicals) |
EphMRA ATC code |
L1G (monoclonal antibody antineoplastics); L4X (other immunosuppressants); N7 (other CNS drugs); S1X1 (other ophthalmologicals, systemic) |
Chemical name |
Immunoglobulin G1, anti-(human CD19 (antigen)) (human monoclonal MEDI-551 heavy chain), disulfide with human monoclonal MEDI-551 kappa-chain, dimer |
Chemical formula |
C6504H10080N1732O2044S44
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