UPLIZNATM Inebilizumab Injection

1. ‌Indications and Usage‌
Indications: UPLIZNA ® (inebilizumab cdon) is suitable for treating adult patients with NMOSD who are positive for anti aquaporin-4 (AQP4) antibodies.
This drug can significantly reduce the risk of recurrence of NMOSD and is suitable for patients who have previously received immunosuppressive therapy or have a high risk of recurrence.
This indication has been approved by the FDA based on the results of the N-MOMentum study, a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 clinical trial.
2. ‌Dosage and Administration‌
Recommended dose: 300 mg intravenous infusion, once in week 1 and week 3 (two doses in total) as induction therapy, followed by repeated maintenance doses every 6 months thereafter.
The infusion time should be ≥ 90 minutes; If well tolerated, it can be shortened to ≥ 60 minutes in the future.
Preparation before administration:
All patients must be screened for hepatitis B virus (HBV) before the first administration.
It is recommended to receive the meningococcal vaccine to prevent the risk of infection, especially when using B-cell depletion agents.
3. ‌Mechanism of Action‌

UPLIZNA is a humanized monoclonal antibody that targets CD19 and selectively depletes B cells (including pre-B cells and mature B cells), thereby reducing the production of self reactive antibodies. Due to the close association between NMOSD and AQP4 IgG autoantibodies, B cell depletion helps to control disease activity.

4. ‌Safety and Warnings‌
Serious infection risk: The depletion of B cells may increase the risk of infection, including progressive multifocal leukoencephalopathy (PML) (with reported cases after marketing).
Common infections: urinary tract infection, upper respiratory tract infection, nasopharyngitis.
If symptoms of infection occur (such as fever, cough, difficulty urinating, etc.), immediate evaluation and medication should be suspended.
Hepatitis B virus reactivation: There have been reports of hepatitis B reactivation in HBV carriers after receiving CD19 targeted treatment, which may lead to acute liver failure or death. Therefore, it is necessary to screen for HBV before treatment and monitor liver function during treatment.
Infusion related reactions: About 10% of patients report that they mostly occur during the first infusion, manifested as fever, chills, headache, and nausea. It is recommended to use antihistamines and antipyretics in advance.
Vaccination suggestions: complete vaccination for all ages at least 4 weeks before starting treatment, especially pneumococcal, influenza and COVID-19 vaccines, because the vaccine response may be weakened during treatment.
5. ‌Adverse Reactions‌
The most common (≥ 10%) adverse reactions are:
Urinary tract infection, headache, joint pain, upper respiratory tract infection, nasopharyngitis, flu like symptoms, fatigue.
Laboratory abnormality:
B cell depletion (near complete clearance) is observed in all patients and typically persists until the next administration.
Mild decrease in IgG levels, but clinically significant hypogammaglobulinemia is rare.
6. ‌Drug Interactions‌
No formal drug interaction studies have been conducted.
When used in combination with other immunosuppressants such as glucocorticoids, azathioprine, and mycophenolate mofetil, it may further increase the risk of infection and requires careful monitoring.
Can be used in combination with conventional NMOSD background therapy.
7. ‌Pharmaceutical Information‌
Product Name: UPLIZNA ®
Common name: Inebilizumab cdon
Dosage form: Freeze dried powder injection for injection (150 mg/vial)
Administration route: intravenous infusion
R&D company: Horizon Therapeutics USA, Inc
FDA Approval Date: June 2020
Storage conditions: Refrigerate at 2-8 ° C, store away from light, do not freeze