Molecule
Inebilizumab is a CD19-directed cytolytic antibody indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Inebilizumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
UPLIZNA is a CD19-directed cytolytic antibody indicated for the treatment of: Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Immunoglobulin G4-related disease (IgG4-RD) in adult patients. Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive.
Source: US FDA prescribing information
The mechanism by which inebilizumab-cdon exerts its therapeutic effects in NMOSD, IgG4-RD, and gMG 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.
Source: US FDA prescribing information
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 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.
Source: US FDA prescribing information
UPLIZNA is contraindicated in patients with: A history of a life-threatening infusion reaction to UPLIZNA Active hepatitis B infection Active or untreated latent tuberculosis Previous life-threatening reaction to infusion of UPLIZNA. Active hepatitis B infection. Active or untreated latent tuberculosis
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions Infections Reduction in Immunoglobulins 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.
Source: US FDA prescribing information
Immunosuppressive or Immune-Modulating Therapies 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.
Source: US FDA prescribing information
Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake. Store vials upright.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Inebilizumab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Uplizna 100 mg/10 mL injectionIntravenous Cold chain | Horizon Therapeutics | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Inebilizumab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Inebilizumab, including Uplizna.
Yes. The US FDA first approved Inebilizumab on 11 June 2020, according to Drugs@FDA.
Yes. Inebilizumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Inebilizumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Inebilizumab is classified under ATC code L04AA (Immunosuppressive drug, subgroup L04AA).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.