inebilizumab-cdon (Uplizna)
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Indications
- treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with aquaporin-4 (AQP4) autoantibodies
- investigational treatment of myasthenia gravis[1]
Dosage
- 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
Monitor
- 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
Adverse effects
- (>10%) urinary tract infection, arthralgia
Mechanism of action
- cytolytic monoclonal antibody directed against CD19
More general terms
References
- ↑ 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
- ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION inebilizumab-cdon (UPLIZNA) injection, for intravenous use https://www.uplizna.com/Uplizna_Prescribing_Information.pdf