Inebilizumab

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.

• 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. ( 1.1 ) Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

• UPLIZNA is contraindicated in patients with: A history of a life-threatening infusion reaction to UPLIZNA [see Warnings and Precautions (5.1) ] Active hepatitis B infection [see Warnings and Precautions (5.2) ] Active or untreated latent tuberculosis [see Warnings and Precautions (5.2) ] Previous life-threatening reaction to infusion of UPLIZNA ( 4 ) Active hepatitis B infection ( 4 ) Active or untreated latent tuberculosis ( 4 )contraindicated

Hepatitis B virus, quantitative serum immunoglobulins, and tuberculosis screening is required before the first dose. ( 2.1 ) Prior to every infusion: Determine if there is an active infection ( 2.2 , 5.2 ) Premedicate with a corticosteroid, an antihistamine, and an antipyretic ( 2.2 , 5.1 ) UPLIZNA must be diluted in 250 mL of 0.9% Sodium Chloride Injection, USP prior to administration. ( 2.3 , 2.4 ) 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. ( 2.3 ) Monitor patients closely during the infusion and for at least one hour after completion of the infusion. ( 2.3 ) 2.1 Assessments Prior to First Dose of UPLIZNA Hepatitis B Virus Screening Prior to initiating UPLIZNA, perform Hepatitis B virus (HBV) screening. UPLIZNA is contraindicated in patients with active HBV confirmed by positive results for surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with UPLIZNA [see Contraindications (4) and Warnings and Precautions (5.2) ]. Serum Immunoglobulins Prior to initiating UPLIZNA, perform testing for quantitative serum immunoglobulins.

Infusion reactions: Administer premedications prior to infusion. ( 2.2 ) 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. ( 5.1 ) 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. ( 5.2 ) 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. ( 5.3 ) 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 6 months after stopping UPLIZNA. ( 5.4 , 8.1 ) 5.1 Infusion Reactions UPLIZNA can cause infusion reactions, including anaphylaxis. Symptoms of infusion reactions can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations.

The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Reduction in Immunoglobulins [see Warnings and Precautions (5.3) ] The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were NMOSD: urinary tract infection and arthralgia. ( 6.1 ) IgG4-RD: urinary tract infections and lymphopenia. ( 6.1 ) gMG: headache and infusion-related reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions NMOSD The safety of UPLIZNA was evaluated in Study 1, in which 161 patients were exposed to UPLIZNA at the recommended dosage regimen during the randomized, controlled treatment period; during which 52 patients received placebo [see Dosage and Administration (2.1) and Clinical Studies (14) ] . Subsequently, 198 patients were exposed to UPLIZNA during an open-label treatment period.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to UPLIZNA during pregnancy or shortly before conception. Healthcare providers are encouraged to advise their patients to register by contacting the UPLIZNA Pregnancy Registry by calling the coordinating center at 1 (303) 724-4644 or www.upliznapregnancyregistry.com. Risk Summary UPLIZNA is a humanized IgG1 monoclonal antibody and immunoglobulins are known to cross the placental barrier. There are no adequate data on the developmental risk associated with the use of UPLIZNA in pregnant women. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy. B-cell levels in infants following maternal exposure to UPLIZNA have not been studied in clinical trials. The potential duration of B-cell depletion in such infants, and the impact of B-cell depletion on vaccine safety and effectiveness, is unknown [see Warnings and Precautions (5.2) ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Metabolism

The pharmacokinetics of inebilizumab-cdon in patients with NMOSD, IgG4-RD, and gMG was similar, and was biphasic with a mean terminal half-life of 18 days. In patients with NMOSD, the mean maximum concentration was 108 µg/mL (following the second 300 mg dose on day 15), and the cumulative AUC of the 26-week treatment period in which NMOSD patients received two intravenous administrations 2 week apart was 2980 µg∙d/mL.

• Jun 11, 2020BLABLA761142Viela Bio

1. 1Neuromyelitis Optica Spectrum Disorder8216%
2. 2Off Label Use509.6%
3. 3Headache366.9%
4. 4Pneumonia305.8%
5. 5Covid-19295.6%
6. 6Urinary Tract Infection275.2%
7. 7Nausea265.0%
8. 8Pain244.6%
9. 9Fatigue224.2%
10. 10Arthralgia203.8%
11. 11Hypoaesthesia183.5%
12. 12Infusion Related Reaction163.1%
13. 13Infection152.9%
14. 14Pyrexia152.9%
15. 15Product Storage Error142.7%

The 10 most recently updated of 29 ClinicalTrials.gov registrations naming Inebilizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
  Recruiting · Phase 2 · Interventional · 15 enrolled · Amgen
  NCT06987539updated 2026-05-29
• A Trial of Inebilizumab in Participants With Autoimmune Hepatitis
  Not yet recruiting · Phase 3 · Interventional · 180 enrolled · Amgen
  NCT07598825updated 2026-05-20
• Myasthenia Gravis Inebilizumab Trial
  Active not recruiting · Phase 3 · Interventional · 238 enrolled · Amgen
  NCT04524273updated 2026-05-15
• A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
  Recruiting · Phase 2 · Interventional · 220 enrolled · Amgen
  NCT06570798updated 2026-05-07
• Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
  Not yet recruiting · Phase 2 · Interventional · 15 enrolled · Amgen
  NCT07222553updated 2026-05-04
• Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD
  Not yet recruiting · Phase 4 · Interventional · 540 enrolled · Massachusetts General Hospital
  NCT07010302updated 2026-03-16
• Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
  Recruiting · Observational · 60 enrolled · Amgen
  NCT05909761updated 2026-01-27
• A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
  Active not recruiting · Phase 3 · Interventional · 135 enrolled · Amgen
  NCT04540497updated 2025-12-11
• A Study of MT-0551 in Patients With Systemic Sclerosis
  Active not recruiting · Phase 3 · Interventional · 80 enrolled · Tanabe Pharma Corporation
  NCT05198557updated 2025-12-08
• Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
  Recruiting · Phase 2 · Interventional · 15 enrolled · Amgen
  NCT05549258updated 2025-12-05

Frequently asked questions

How does Inebilizumab work?

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.

What is Inebilizumab used for?

According to FDA labeling, Inebilizumab carries indications including: 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. ( 1.1 ) Immunoglobulin G4-related disease (IgG4-RD) in adult patients.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Inebilizumab?

Inebilizumab is classified as Monoclonal antibodies, CD19-directed Cytolytic Antibody, CD19-directed Antibody Interactions, Increased Lymphocyte Cell Destruction.

What are the brand names for Inebilizumab?

Inebilizumab is marketed under brand names including Uplizna.

What are the contraindications for Inebilizumab?

Inebilizumab labeling lists contraindications including: UPLIZNA is contraindicated in patients with: A history of a life-threatening infusion reaction to UPLIZNA [see Warnings and Precautions (5.1) ] Active hepatitis B infection [see Warnings and Precautions (5.2) ] Active or untreated latent tuberculosis [see Warnings and Precautions (5.2) ] Previous life-threatening reaction to infusion of UPLIZNA ( 4 ) Active hepatitis B infection ( 4 ) Active or untreated latent tuberculosis ( 4 ). Always consult the full prescribing information and a clinician.