inebilizumab-cdon (Uplizna)

Indications

• treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with aquaporin-4 (AQP4) autoantibodies

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

• drug adverse effects of pharmaceutical monoclonal antibodies

Mechanism of action

• cytolytic monoclonal antibody directed against CD19

More general terms

• pharmaceutical monoclonal antibody
• neurologic agent