General Information

Uplizna (inebilizumab-cdon) is a CD19-directed cytolytic antibody.

Uplizna is specifically indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Uplizna is supplied as an injection for intravenous administration. Hepatitis B virus, quantitative serum immunoglobulins, and tuberculosis screening is required before the first dose. Prior to every infusion: determine if there is an active infection and premedicate with a corticosteroid, an antihistamine, and an antipyretic. Uplizna must be diluted in 250 mL of 0.9% Sodium Chloride Injection, USP prior to administration. Uplizna is administered as an intravenous infusion titrated to completion, approximately 90 minutes. The recommended dose is:

• Initial dose: 300 mg intravenous infusion followed two weeks later by a second 300 mg intravenous infusion
• Subsequent doses (starting 6 months from the first infusion): single 300 mg intravenous infusion every 6 months  

Monitor patients closely during the infusion and for at least one hour after completion of the infusion.

Mechanism of Action

Uplizna (inebilizumab-cdon) is a CD19-directed cytolytic antibody. The precise mechanism by which inebilizumab-cdon exerts its therapeutic effects in NMOSD is unknown but is presumed to involve binding to CD19, a cell surface antigen presents on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, inebilizumab-cdon results in antibody-dependent cellular cytolysis.

Side Effects

Adverse effects associated with the use of Uplizna may include, but are not limited to, the following:

• urinary tract infection
• arthralgia
• nausea
• headache
• back pain

The prescribing information for Uplizna includes a warning for infusion reactions, potential depletion of certain proteins (hypogammaglobulinemia), and potential increased risk of infection – including Progressive Multifocal Leukoencephalopathy, and potential reactivation of hepatitis B and tuberculosis.

Clinical Trial Results

The FDA approval of Uplizna was based on a randomized (3:1), double-blind, placebo-controlled trial that enrolled 213 patients with NMOSD who were anti-AQP4 antibody positive and 17 who were anti-AQP4 antibody negative. During the 197-day study, the risk of an NMOSD relapse in the 161 anti-AQP4 antibody positive patients who were treated with Uplizna was reduced by 77% when compared to the placebo treatment group. There was no evidence of a benefit in patients who were anti-AQP4 antibody negative.