inebilizumab-cdon (Uplizna)

^[1]^[2]^[3]

Indications

treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with aquaporin-4 (AQP4) autoantibodies
investigational treatment of myasthenia gravis^[1]
treatment of IgG4 disease (FDA-approved April 2025)^[2]

premedicate with a corticosteroid, an antihistamine, & an antipyretic
dilute in 250 mL of 0.9% Sodium Chloride Injection, USP prior to administration
intravenous infusion titrated to completion, ~90 minutes
initial dose: 300 mg intravenous infusion
- follow in two weeks with a second 300 mg intravenous infusion
subsequent doses (starting 6 months from the first infusion):
- single 300 mg intravenous infusion every 6 months

Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial

screening for Hepatitis B virus, screening for tuberculosis & quantitative serum immunoglobulins required before 1st dose
monitor patients closely during the infusion and for at least one hour after completion of infusion

↑ ^1.0 ^1.1 George J Anti-CD19 Monoclonal Antibody Shows Positive Results in Myasthenia Gravis. Topline phase III data show inebilizumab met primary endpoint. MedPage Today October 15, 2024 https://www.medpagetoday.com/meetingcoverage/aanem/112412
↑ ^2.0 ^2.1 Beesley D, Sunny ME, Mahatole S. US FDA approves Amgen's Uplizna as first treatment for rare immune disorder. Reuters. April 3, 2025 https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-expanded-use-amgens-rare-disease-drug-2025-04-03/
↑ HIGHLIGHTS OF PRESCRIBING INFORMATION inebilizumab-cdon (UPLIZNA) injection, for intravenous use https://www.uplizna.com/Uplizna_Prescribing_Information.pdf