Horizon Therapeutics Uplizna (inebilizumab-cdon)

Published: February 24, 2026

Uplizna (inebilizumab-cdon) is a CD19-directed cytolytic antibody indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD), immunoglobulin G4 related disease (IgG4-RD), and generalized myasthenia gravis (gMG) in adults. Uplizna was first approved in June 2020 for the treatment of NMOSD, and has since received two additional FDA approvals.

Read on to learn more about Uplizna, including contraindications, dosage and administration information, adverse reactions, and more.

Medication Overview:

Brand Name: Uplizna
Generic Name: inebilizumab-cdon
Treatment for: Neuromyelitis optica spectrum disorder, immunoglobulin G4-related disease, generalized myasthenia gravis
Manufacturer: Horizon Therapeutics
Initial FDA Approval: June 2020

Indicated Condition	Indication	Age	Date Approved
Neuromyelitis Optica Spectrum Disorder (NMOSD)	Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.	Adults	June 2020
IgG4-Related Disease (IgG4-RD)	Indicated for the treatment of immunoglobulin G4-related disease (IgG4-RD) in adult patients.	Adults	April 2025
Generalized Myasthenia Gravis (gMG)	Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti- acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive.	Adults	December 2025

Warnings and Precautions:

Infusion reactions: Administer premedications prior to infusion. Management recommendations for infusion reactions depend on the type and severity of the reaction. Permanently discontinue Uplizna if a life-threatening or disabling infusion reaction occurs.

Infections: Serious, including life-threatening and fatal infections, have occurred in patients treated with B-cell depleting therapies, including Uplizna. Delay Uplizna administration in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Immunoglobulin Levels: Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with Uplizna until B-cell repletion. Consider discontinuing Uplizna if a patient develops a serious opportunistic infection or recurrent infections if immunoglobulin levels indicate immune compromise.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for six months after stopping Uplizna.

Dosage and 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.
Premedicate with 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 six months from the first infusion): single 300 mg intravenous infusion every six months.

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

Contraindications:

Previous life-threatening reaction to infusion of Uplizna.
Active hepatitis B infection.
Active or untreated latent tuberculosis.

Drug Interactions:

Concomitant usage of Uplizna with immunosuppressant drugs, including systemic corticosteroids, may increase the risk of infection. Consider the risk of additive immune system effects when co-administering immunosuppressive therapies with Uplizna.

Adverse Reactions:

The most common adverse reactions (at least 10% of patients treated with Uplizna and greater than placebo) were:

NMOSD: urinary tract infection and arthralgia.
IgG4-RD: urinary tract infections and lymphopenia.
gMG: headache and infusion-related reactions.

Examples of Inebilizumab in Guidelines:

Diagnosis and Management of Neuromyelitis Optica Spectrum Disorder

Consensus and Physician Experts, November 2025
“Monoclonal antibodies such as eculizumab, ravulizumab, tocilizumab, or inebilizumab may be considered for patients who cannot tolerate or do not respond to rituximab or conventional immunosuppressants.”

Please note: This article is current as of February 23, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.