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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Frequently Asked Questions

Review answers to common questions related to UPLIZNA and IgG4-related disease.

  • What is IgG4-RD?

    IgG4-RD is a chronic systemic fibroinflammatory disease that can present in nearly any organ system.1,2 IgG4-RD is heterogeneous with a tendency for multiorgan involvement.2 Learn more about IgG4-RD

  • What is the etiology of IgG4-RD?

    The exact cause of IgG4-RD is still unknown. However, it is believed that CD19+ B cells may drive inflammation and fibrosis directly through cytokines or indirectly through the activation of pathogenic T cells.3,4 Explore IgG4-RD pathogenesis

  • What role do B cells play in IgG4-RD?

    B cells, including plasmablasts and some plasma cells, promote secretion of proinflammatory cytokines, which may drive downstream inflammation through their interaction with other immune cells.2-4 Elevated plasmablasts and plasma cells are believed to drive inflammation and fibrosis in IgG4-RD.2-5 See how IgG4-RD may present

  • What are the implications of IgG4-RD relapses and flares?

    Frequent disease flares and inadequate disease control may lead to permanent organ damage over time.6,7 Awareness of how organ damage manifests is critically important to inform the timely diagnosis of IgG4-RD.2 Explore IgG4-RD disease course

  • What is the mechanism of action of UPLIZNA for IgG4-RD?

    While the precise mechanism by which UPLIZNA exerts its therapeutic effects in IgG4-RD is unknown, it is presumed to involve binding to CD19—a cell surface antigen present on pre-B and mature B lymphocytes.8 Following cell surface binding to B lymphocytes, UPLIZNA results in antibody-dependent cellular cytosis.8 Watch to learn more

  • What was the pivotal trial that studied UPLIZNA for IgG4-RD?

    MITIGATE was a randomized double-blind multicenter 52-week placebo-controlled trial of 135 adult IgG4-RD patients who had organ involvement and were newly diagnosed or had recurrent disease.9 Learn more about the study design

  • How was an IgG4-RD flare defined in the MITIGATE trial?

    In the MITIGATE clinical trial, a flare was defined by the investigator as new or worsening signs or symptoms that warranted treatment and met ≥1 protocol-defined, organ-specific flare criteria as determined by an independent AC.8,9 See how flares were studied in the MITIGATE clinical trial

  • Is UPLIZNA proven to reduce the risk of IgG4-RD flares?

    Yes, in the MITIGATE clinical trial, UPLIZNA significantly reduced the risk of IgG4-RD flares by 87% vs placebo over 52 weeks.8 7 out of 68 patients on UPLIZNA (10.3%) experienced IgG4-RD flares vs 40 out of 67 patients on placebo (59.7%) at Week 52 (HR: 0.13 [95% CI: 0.06, 0.28]; P<0.0001).8 See full efficacy data

  • What were the most common side effects of UPLIZNA in the MITIGATE trial?

    Lymphopenia* and urinary tract infection were adverse events with an incidence of ≥10% and were seen more frequently with UPLIZNA than with placebo.8 These are not all the side effects of UPLIZNA. Explore safety data

  • What is the risk for infusion-related reactions with UPLIZNA?

    UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms.8 In the 52-week RCP, rates of infusion reactions with UPLIZNA were 7.4% vs 14.9% with placebo.8,10 Infusion reactions were most common with the first infusion but were also observed during subsequent infusions.8 A corticosteroid 30 minutes prior, an antihistamine, and an antipyretic are given 30 to 60 minutes prior to administration to reduce infusion reactions, and patients are monitored up to 90 minutes after each infusion is complete.8 Explore safety data

  • What is the dosing schedule for UPLIZNA?

    UPLIZNA is infused every 6 months after 2 initial doses 2 weeks apart.8 The dosing schedule is Day 1, Day 15, Week 26, Week 52.8 Learn more about dosing

  • How is UPLIZNA administered?

    UPLIZNA is administered by intravenous infusion.8 The recommended dose is a 300-mg infusion followed 2 weeks later by a second 300-mg infusion.8 Subsequent doses (starting 6 months from the first infusion) are a single 300-mg infusion every 6 months for maintenance treatment.8 A corticosteroid 30 minutes prior, an antihistamine, and an antipyretic are given 30 to 60 minutes prior to administration to reduce infusion reactions.8 Learn more about administration

  • What support is available for patients taking UPLIZNA?

    Amgen By Your Side is a support program for patients prescribed UPLIZNA. Our dedicated team is your patient’s partner, committed to providing nonmedical support to help patients as they start and continue on treatment as you prescribe. Learn more about Amgen By Your Side

*Lymphopenia includes both lymphopenia and decreased lymphocyte count.

AC, adjudication committee; IgG4-RD, immunoglobulin G4-related disease; RCP, randomized clinical trial period.

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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: Can cause infusion reactions, including anaphylaxis. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. During the randomized clinical trial period (RCP), infusion reactions were observed with the first course of UPLIZNA in 9.3% of NMOSD patients. Infusion reactions of UPLIZNA were observed in 7.4% of IgG4-RD patients during the RCP. 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: An increased risk of infections has been observed with other B-cell depleting therapies. The most common infections reported by UPLIZNA-treated patients in the NMOSD RCP and open-label clinical trial periods were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP and open-label period, the most common infections reported by UPLIZNA-treated patients were upper respiratory tract infection (11%), nasopharyngitis (10%), urinary tract infection (9%), and influenza (6%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved. 

    Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: UPLIZNA has not been studied in combination with other immunosuppressants. If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects. 

    Hepatitis B Virus (HBV) Reactivation: Risk of HBV reactivation has been observed with other B-cell depleting antibodies. There have been no cases of HBV reactivation in patients treated with UPLIZNA, but patients with 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 hepatitis. For patients who are chronic carriers of HBV [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 in NMOSD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.
  • The most common adverse reactions in IgG4-RD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infections and lymphopenia. 

INDICATIONS

UPLIZNA® (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

UPLIZNA® is indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

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: Can cause infusion reactions, including anaphylaxis. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. During the randomized clinical trial period (RCP), infusion reactions were observed with the first course of UPLIZNA in 9.3% of NMOSD patients. Infusion reactions of UPLIZNA were observed in 7.4% of IgG4-RD patients during the RCP. 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: An increased risk of infections has been observed with other B-cell depleting therapies. The most common infections reported by UPLIZNA-treated patients in the NMOSD RCP and open-label clinical trial periods were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP and open-label period, the most common infections reported by UPLIZNA-treated patients were upper respiratory tract infection (11%), nasopharyngitis (10%), urinary tract infection (9%), and influenza (6%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: UPLIZNA has not been studied in combination with other immunosuppressants. If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects. 

    Hepatitis B Virus (HBV) Reactivation: Risk of HBV reactivation has been observed with other B-cell depleting antibodies. There have been no cases of HBV reactivation in patients treated with UPLIZNA, but patients with 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 hepatitis. For patients who are chronic carriers of HBV [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: BBased 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 in NMOSD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia. 
  • The most common adverse reactions in IgG4-RD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infections and lymphopenia.

INDICATIONS

UPLIZNA® (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

UPLIZNA® is indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

Please see UPLIZNA Full Prescribing Information.

  • REFERENCES:
    1. Stone JH, Zen Y, Deshpande V. N Engl J Med. 2012;366(6):539-551.
    2. Perugino CA, Stone JH. Nat Rev Rheumatol. 2020;16(12):702-714.
    3. Lanzillotta M, Stone JH, Della-Torre E. Mod Rheumatol. 2023;33:258-265.
    4. Lanzillotta M, Culver E, Sharma A, et al. Lancet Rheumatol. 2024;6(7):e469-e480.
    5. Lin W, Li P, Chen H, et al. Arthritis Res Ther. 2017;19:25.
    6. Zhang L, Wang Z, Sokol L, et al. Lancet Rheumatol. 2019;1(1):e55-e64.
    7. Tanaka Y, Takeuchi T, Shiokawa M. Mod Rheumatol. 2023;33(4):456-467.
    8. UPLIZNA® (inebilizumab-cdon) [prescribing information] Amgen.
    9. Stone JH, Khosroshahi A, Zhang W, et al. N Engl J Med. 2025;392:1168-1177.
    10. Data on File. Amgen [1]; 2024.