INDICATIONS
UPLIZNA® (inebilizumab-cdon) is indicated in adult patients for the treatment of: anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD); Immunoglobulin G4-related disease (IgG4-RD); anti-...

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Additional consensus statements from the international panel of NMOSD experts included:

  • Treatment with monotherapy is preferable to reduce IST-related side effects10
  • Patient preference should be a consideration when initiating or switching treatment10
  • Current clinical disease activity, serious treatment-related adverse events, and patient preference for another therapy should warrant switching treatment10
  • Vaccinations should be kept up to date, with specific guidance concerning meningococcal vaccination when prescribing eculizumab10

*The NMOSD Delphi Panel was convened to develop validated recommendations on the treatment of AQP4-IgG+ patients with NMOSD. This international panel of clinical experts drafted consensus statements regarding therapy initiation, monotherapy vs combination therapy, switching therapies, patient populations, safety, use of biomarkers and patient-reported outcomes, and gaps in research. Of 18 panelists, 14 agreed on the same initiation criteria for eculizumab, and 17 for satralizumab. Each therapy met the panel’s predefined consensus threshold (67% or greater).

AQP4-IgG+, aquaporin-4-immunoglobulin G positive; IST, immunosuppressive therapy; NMOSD, neuromyelitis optica spectrum disorder.

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Early diagnosis through cell-based testing is crucial to beginning treatment1-3

  • AQP4-IgG is an NMOSD autoantibody that is not present in MS2
  • A cell-based assay is the most reliable method to detect AQP4-IgG autoantibodies, which are present in ~75% of NMOSD cases1,3-5

To receive confirmation of your suspected NMOSD diagnosis, consider a cell-based assay from the labs listed here:

The following laboratories provide cell-based assay (CBA) testing:*

ARUP Laboratories6 Athena Diagnostics7 Labcorp8 Mayo Clinic Laboratories9 Neurocode10 Quest Diagnostics11
Website Aruplab.com Athenadiagnostics.com Labcorp.com Mayocliniclabs.com Neurocode.com Questdiagnostics.com
Method CBA CBA IFA FACS CBA CBA
Lab Test Code 2013322 1282 505295 43638-6 (can be ordered with form online) AQP4 CBA 93893
CPT Code 86052 (if reflexed, add 86256) 86052 86052 86053 86052 86052
Specimen Requirements Collect 1 mL (0.15 mL minimum) serum using a serum separator or a red-top tube then transfer to an ARUP Standard Transport Tube, refrigerated Collect 2 mL (0.5 mL minimum) serum using a serum separator or a red-top tube, refrigerated Collect 2 mL (1 mL minimum) serum using a red-top tube, room temperature Collect 3 mL (2 mL minimum) serum using a red-top tube, refrigerated Collect 3 mL (0.5 mL minimum) serum in a gold-top tube, refrigerated Collect 0.5 mL (0.3 mL minimum) serum in a red-top tube (no gel) or CSF collected in sterile screw-cap container, then transfer to a transport tube, room temperature
Turnaround Time 1-6 days 3-7 days 1-2 days 5-8 days 1 week Varies by region
Reference Values <1:10 titer See laboratory report See laboratory report Negative See laboratory report Negative
Website ARUP Laboratories6 Aruplab.com Athena Diagnostics7 Athenadiagnostics.com Labcorp8 Labcorp.com Mayo Clinic Laboratories9 Mayocliniclabs.com Neurocode10 Neurocode.com Quest Diagnostics11 Questdiagnostics.com
Method ARUP Laboratories6 CBA Athena Diagnostics7 CBA Labcorp8 IFA Mayo Clinic Laboratories9 FACS Neurocode10 CBA Quest Diagnostics11 CBA
Lab Test Code ARUP Laboratories6 2013322 Athena Diagnostics7 1282 Labcorp8 505295 Mayo Clinic Laboratories9 43638-6 (can be ordered with form online) Neurocode10 AQP4 CBA Quest Diagnostics11 93893
CPT Code ARUP Laboratories6 86052 (if reflexed, add 86256) Athena Diagnostics7 86052 Labcorp8 86052 Mayo Clinic Laboratories9 86053 Neurocode10 86052 Quest Diagnostics11 86052
Specimen Requirements ARUP Laboratories6 Collect 1 mL (0.15 mL minimum) serum using a serum separator or a red-top tube then transfer to an ARUP Standard Transport Tube, refrigerated Athena Diagnostics7 Collect 2 mL (0.5 mL minimum) serum using a serum separator or a red-top tube, refrigerated Labcorp8 Collect 2 mL (1 mL minimum) serum using a red-top tube, room temperature Mayo Clinic Laboratories9 Collect 3 mL (2 mL minimum) serum using a red-top tube, refrigerated Neurocode10 Collect 3 mL (0.5 mL minimum) serum in a gold-top tube, refrigerated Quest Diagnostics11 Collect 0.5 mL (0.3 mL minimum) serum in a red-top tube (no gel) or CSF collected in sterile screw-cap container, then transfer to a transport tube, room temperature
Turnaround Time ARUP Laboratories6 1-6 days Athena Diagnostics7 3-7 days Labcorp8 1-2 days Mayo Clinic Laboratories9 5-8 days Neurocode10 1 week Quest Diagnostics11 Varies by region
Reference Values ARUP Laboratories6 <1:10 titer Athena Diagnostics7 See laboratory report Labcorp8 See laboratory report Mayo Clinic Laboratories9 Negative Neurocode10 See laboratory report Quest Diagnostics11 Negative

*The information in this chart is provided for general informational purposes only. The laboratories listed above are those currently known to provide CBA testing as of October 16, 2025. Amgen neither recommends nor endorses any particular laboratory and may or may not have financial relationships with these entities. This list is not comprehensive, and other laboratories may also perform this testing. Insurance coverage for laboratory services varies based on individual plan benefits. Healthcare providers should confirm testing coverage directly with their patients' insurance providers prior to ordering.

Cell-based assays are strongly recommended for their higher sensitivity and specificity—the likelihood of a false-negative result with an ELISA assay is almost 5x greater. False negatives are also more likely to occur during the recovery period following an attack or when taking an immunosuppressant. Consider retesting an AQP4-IgG– patient within 3 to 6 months.1,12,13

AQP4-IgG+ patient? Explore how UPLIZNA works

AQP4-IgG4, aquaporin-4 immunoglobulin G; ARUP, Associated Regional and University Pathologists; CPT, current procedural terminology; FACS, fluorescence-activated cell sorting; IFA, immunofluorescence assay; NMOSD, neuromyelitis optica spectrum disorder; MS, multiple sclerosis.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

UPLIZNA® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis. 

WARNINGS AND PRECAUTIONS

  • Infusion Reactions: Infusion reactions, including anaphylaxis, can occur. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. Infusion reactions were observed in 9.3%, 7.4%, and 10.1% of patients treated with UPLIZNA during the randomized controlled periods (RCPs) of Study 1 in patients with NMOSD, Study 2 in patients with IgG4-RD, and Study 3 in patients with gMG, respectively. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions.

    Administer pre-medication with a corticosteroid, an antihistamine, and an antipyretic. For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. 
  • Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with B-cell depleting therapies, including UPLIZNA. The most common infections reported by UPLIZNA-treated patients in the NMOSD randomized and open-label clinical trial periods for NMOSD were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection, influenza, and pneumonia. In the gMG RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection and nasopharyngitis. Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects. 

    Hepatitis B Virus (HBV) Reactivation: HBV reactivation has been observed with B-cell-depleting therapies, including UPLIZNA. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with B-cell depleting therapies. HBV reactivation was observed in a patient treated with UPLIZNA during the gMG clinical trial and in the postmarketing setting. Patients with active or chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment. Do not administer to patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for HBsAg and positive for HBcAb, or who are carriers of HBV (i.e., HBsAg+), consult liver disease experts before starting and during treatment.

    Progressive Multifocal Leukoencephalopathy (PML): Although no confirmed cases of PML were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. 

    Tuberculosis
    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment.

    Vaccinations
    Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion. 
    Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy
    In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B cells in these exposed infants may increase the risks from live or live-attenuated vaccines. Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.
  • Reductions in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the levels of quantitative serum immunoglobulins during treatment with UPLIZNA, especially in patients with opportunistic or recurrent infections, and until B-cell repletion after discontinuation of therapy. Consider discontinuing UPLIZNA therapy if a patient with low immunoglobulin G or M develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. 
  • Fetal Risk: Based on animal data, UPLIZNA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to UPLIZNA even after B-cell repletion. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell-depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving UPLIZNA and for at least 6 months after the last dose. 

ADVERSE REACTIONS

  • The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo): urinary tract infection and arthralgia in NMOSD; urinary tract infection and lymphopenia in IgG4-RD; headache and infusion-related reactions in gMG.

INDICATIONS

UPLIZNA® (inebilizumab-cdon) is indicated in adult patients for the treatment of: anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD); Immunoglobulin G4-related disease (IgG4-RD); anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive (Ab+) generalized myasthenia gravis (gMG).

Please see UPLIZNA Full Prescribing Information.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

UPLIZNA® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis. 

WARNINGS AND PRECAUTIONS 

  • Infusion Reactions: Infusion reactions, including anaphylaxis, can occur. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. Infusion reactions were observed in 9.3%, 7.4%, and 10.1% of patients treated with UPLIZNA during the randomized controlled periods (RCPs) of Study 1 in patients with NMOSD, Study 2 in patients with IgG4-RD, and Study 3 in patients with gMG, respectively. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions.

    Administer pre-medication with a corticosteroid, an antihistamine, and an antipyretic. For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
  • Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with B-cell depleting therapies, including UPLIZNA. The most common infections reported by UPLIZNA-treated patients in the NMOSD randomized and open-label clinical trial periods for NMOSD were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection, influenza, and pneumonia. In the gMG RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection and nasopharyngitis. Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects. 

    Hepatitis B Virus (HBV) Reactivation: HBV reactivation has been observed with B-cell-depleting therapies, including UPLIZNA. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with B-cell depleting therapies. HBV reactivation was observed in a patient treated with UPLIZNA during the gMG clinical trial and in the postmarketing setting. Patients with active or chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment. Do not administer to patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for HBsAg and positive for HBcAb, or who are carriers of HBV (i.e., HBsAg+), consult liver disease experts before starting and during treatment.

    Progressive Multifocal Leukoencephalopathy (PML): Although no confirmed cases of PML were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. 

    Tuberculosis
    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment. 

    Vaccinations
    Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion. 
    Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy
    In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B cells in these exposed infants may increase the risks from live or live-attenuated vaccines. Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.
  • Reductions in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the levels of quantitative serum immunoglobulins during treatment with UPLIZNA, especially in patients with opportunistic or recurrent infections, and until B-cell repletion after discontinuation of therapy. Consider discontinuing UPLIZNA therapy if a patient with low immunoglobulin G or M develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
  • Fetal Risk: Based on animal data, UPLIZNA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to UPLIZNA even after B-cell repletion. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell-depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving UPLIZNA and for at least 6 months after the last dose.

ADVERSE REACTIONS

  • The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo): urinary tract infection and arthralgia in NMOSD; urinary tract infection and lymphopenia in IgG4-RD; headache and infusion-related reactions in gMG.

INDICATIONS

UPLIZNA® (inebilizumab-cdon) is indicated in adult patients for the treatment of: anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD); Immunoglobulin G4-related disease (IgG4-RD); anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive (Ab+) generalized myasthenia gravis (gMG).

Please see UPLIZNA Full Prescribing Information.

  • REFERENCES:
    1. Wingerchuk DM, Banwell B, Bennett JL, et al; Neurology. 2015;85(2):177-189.
    2. Borisow N, Mori M, Kuwabara S, Scheel M, Paul F. Front Neurol. 2018;9(888):1-15.
    3. Hamid SHM, Whittam D, Mutch K, et al. J Neurol. 2017;264(10):2088-2094.
    4. Jiao Y, Fryer JP, Lennon VA, et al. Neurology. 2013;81(14):1197-1204.
    5. Jarius S, Ruprecht K, Wildemann B, et al. J Neuroinflammation. 2012;9(14):1-17.
    6. Aquaporin-4 Receptor Antibody, IgG by IFA with Reflex to Titer, Serum. ARUP Laboratories. Accessed April 29, 2026. https://ltd.aruplab.com/Tests/Pub/2013320
    7. Aquaporin-4 (AQP4) (NMO-IgG) Antibody, CBA with Reflex to Titer. Athena Diagnostics. Accessed April 29, 2026. https://www.athenadiagnostics.com/view-full-catalog/aquaporin-4-aqp4-nmo-igg-antibody-cba-with-reflex-to-titer1
    8. Anti-Aquaporin 4 (AQP4), Serum. Labcorp, Accessed April 29, 2026. https://www.labcorp.com/tests/505295/anti-aquaporin-4-aqp4-serum
    9. Test ID: NMOFS, Neuromyelitis Optica (NMO)/Aquaporin-4-IgG Fluorescence-Activated Cell Sorting (FACS) Assay, Serum. Mayo Clinic Laboratories. Accessed May 15, 2024. https://www.mayocliniclabs.com/test-catalog/overview/38324
    10. Aquaporin-4 Antibodies by Live Cell-Based Assay (AQP4 CBA). Neurocode. Accessed March 2026.
    11. Aquaporin-4 (AQP4) (NMO-IgG) Antibody with Reflex to Titer, Serum. Quest Diagnostics. Accessed April 29, 2026. https://testdirectory.questdiagnostics.com/test/test-detail/38321/aquaporin-4-aqp4-nmo-iggantibody-with-reflex-to-titer-serum?q=38321&cc=MASTER
    12. Prain K, Woodhall M, Vincent A, et al; Australian and New Zealand NMO Collaboration. Front Neurol. 2019;10(1028):1-7.
    13. Waters PJ, Pittock SJ, Bennett JL, Jarius S, Weinshenker BG, Wingerchuk DM. Clin Exp Neuroimmunol. 2014;5(3):290-303.