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);

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Patients with anti-AChR Ab+ and anti-MuSK Ab+ gMG receiving UPLIZNA resulted in ~2x greater improvement in MG-ADL scores vs placebo at Week 262

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Proportion of participants with baseline steroid use of >5 mg/day who reduced steroid use to ≤5 mg/day at Week 26, n/N (%)4,*

Patients taking ≤5 mg/day of steroids4,5,*

Primary Endpoint: Graph comparing baseline and week 26, showing that by week 26, 87% of patients on UPLIZNA were receiving <5mg/day of steroids (vs 85% on placebo)³

Mean dose of steroids:

  • Baseline: UPLIZNA, 17.0 mg/day; placebo, 18.8 mg/day2
  • Week 26: UPLIZNA, 5.4 mg/day; placebo, 5.5 mg/day6

Steroid use of ≤5 mg/day was an additional secondary endpoint and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

*Steroid use at Week 26 was calculated only in patients taking >5 mg/day at baseline.

The Myasthenia Gravis—Activities of Daily Living (MG-ADL) scale assesses the impact of gMG on daily functions6

Functional assessments include:6

  • Ocular
  • Bulbar
  • Respiratory
  • Limb

Impairment in each symptom is graded from 0 (normal) to 3 (most severe impairment). The scores are added together to provide a total from 0 to 24, with higher scores indicating more severe disease.2,6 A 2-point improvement in the MG-ADL score is considered a clinically meaningful improvement.2

gMG, generalized myasthenia gravis.

Depth of response with UPLIZNA vs placebo at 26 weeks5

Exploratory Endpoint: Proportion of patients showing various levels of MG-ADL improvement at Week 26
(anti-AChR and anti-MuSK Ab+)5

Exploratory Endpoint graph showing proportion of patients showing various levels of MG-ADL improvement at week 26, highlighting 68.7% of patients receiving UPLIZNA had a ≥3-point improvement in MG-ADL score (vs 48.2% of patients on placebo)

68.7% of patients receiving UPLIZNA had a ≥3-point improvement in MG-ADL score (vs 48.2% of patients on placebo)2

≥3-point improvement in MG-ADL score was an additional secondary endpoint and depth of response is an exploratory analysis. Neither have been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

Ab+, antibody positive; AChR, acetylcholine receptor; MG-ADL, Myasthenia Gravis-Activities of Daily Living; MuSK, muscle specific tyrosine kinase.

Change from baseline in MG-ADL score at Week 26 in the combined trial population (anti-AChR and anti-MuSK Ab+)1,2

Line graph displaying Primary Endpoint: Change in MG-ADL scores through week 26, UPLIZNA showing a 1.9 point improvement compared to placebo Icon with a green border displaying the text:
Line graph displaying Primary Endpoint: Change in MG-ADL scores through week 26, UPLIZNA showing a 1.9 point improvement compared to placebo - Icon with a green border displaying the text: "1.9 point difference in MG-ADL vs placebo (P<0.001)²"

Related charts

  • A -2.6 point improvement in MG-ADL was observed with UPLIZNA at Week 4 while a -2.5 point improvement was observed for placebo1,3
  • 68.7% of patients receiving UPLIZNA had a ≥3-point difference in MG-ADL score (vs 48.2% of patients on placebo)2

Results at Week 4 were not a prespecified endpoint and ≥3-point improvement in MG-ADL score was an additional secondary endpoint.

Neither of these results have been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.²

Ab+, antibody positive; AChR, acetylcholine receptor; MG-ADL, Myasthenia Gravis–Activities of Daily Living; MuSK, muscle specific tyrosine kinase.

Proportion of participants with baseline steroid use of >5 mg/day who reduced steroid use to ≤5 mg/day at Week 26, n/N (%)4,*

Patients taking ≤5 mg/day of steroids4,5,*

QMG: Graph comparing baseline and week 26, showing that by week 26, 87% of patients on UPLIZNA were receiving <5mg/day of steroids (vs 85% on placebo)⁴

Mean dose of steroids:

  • Baseline: UPLIZNA, 17.0 mg/day; placebo, 18.8 mg/day2
  • Week 26: UPLIZNA, 5.4 mg/day; placebo, 5.5 mg/day6

Steroid use of ≤5 mg/day was an additional secondary endpoint and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

*Steroid use at Week 26 was calculated only in patients taking >5 mg/day at baseline.

Quantitative myasthenia gravis (QMG) score is a physician-reported standardized clinical tool used to assess the severity of gMG8

QMG assesses a range of 13 potential symptoms or functional limitations in several areas, including

  • Respiratory function
  • Bulbar function
  • Ocular function
  • Limb function

Each group is scored from 0 (normal) to 3 (severe impairment). The scores are added to provide a total from 0 to 39, with higher scores indicating more severe disease.8 The clinically meaningful improvement threshold for QMG score is generally considered to be a ≥3-point reduction from baseline.2

gMG, generalized myasthenia gravis.

UPLIZNA provided a clinically meaningful improvement in QMG score2 Key Secondary Endpoint: Change from baseline in QMG score at Week 26 in the combined trial population (anti-AChR and anti-MuSK Ab+)1,2

QMG line graph displaying proportion of patients showing various levels of MG-ADL improvement in patients, UPLIZNA showing a 2.5 point improvement compared to placebo Icon with a green border displaying the text:
QMG line graph displaying proportion of patients showing various levels of MG-ADL improvement in patients, UPLIZNA showing a 2.5 point improvement compared to placebo - Icon with a green border displaying the text: "2.5 point improvement in QMG vs placebo (P<0.001)¹"

Related charts

  • 59.8% of patients receiving UPLIZNA had a ≥3-point difference in QMG score (vs 41.1% of patients on placebo)

Both subsets of patients receiving UPLIZNA showed reduction in QMG score at Week 261

  • Anti-AChR Ab+: UPLIZNA, -4.4 points; placebo, -2.0 points (P=0.0001)
  • Anti-MuSK Ab+:* UPLIZNA, -5.2 points; placebo, -3.0 points (difference was not statistically significant)

≥3-point difference in MG-ADL score was an additional secondary endpoint and has not been adjusted for multiple comparisons.

No conclusions of statistical or clinical significance can be drawn.4 

Ab+, antibody positive; AChR, acetylcholine receptor; MG-ADL, Myasthenia Gravis–Activities of Daily Living; MuSK, muscle specific tyrosine kinase; QMG, quantitative myasthenia gravis score.

Proportion of participants with baseline steroid use of >5 mg/day who reduced steroid use to ≤5 mg/day at Week 26, n/N (%)4,*

Patients taking ≤5 mg/day of steroids4,5,*

MG-ADL by Serotype: Graph comparing baseline and week 26, showing that by week 26, 87% of patients on UPLIZNA were receiving <5mg/day of steroids (vs 85% on placebo)⁴

Mean dose of steroids:

  • Baseline: UPLIZNA, 17.0 mg/day; placebo, 18.8 mg/day2
  • Week 26: UPLIZNA, 5.4 mg/day; placebo, 5.5 mg/day6

Steroid use of ≤5 mg/day was an additional secondary endpoint and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

*Steroid use at Week 26 was calculated only in patients taking >5 mg/day at baseline.

The Myasthenia Gravis—Activities of Daily Living (MG-ADL) scale assesses the impact of gMG on daily functions6

Functional assessments include:6

  • Ocular
  • Bulbar
  • Respiratory
  • Limb

Impairment in each symptom is graded from 0 (normal) to 3 (most severe impairment). The scores are added together to provide a total from 0 to 24, with higher scores indicating more severe disease.2,6 A 2-point improvement in the MG-ADL score is considered a clinically meaningful improvement.2

gMG, generalized myasthenia gravis.

Depth of response with UPLIZNA vs placebo at 26 weeks in the anti-AChR Ab+ population4

Exploratory Endpoint: Proportion of patients showing various levels of MG-ADL improvement at Week 26 (Anti-AChR Ab+)2,5

Exploratory Endpoint chart showing proportion of patients showing various levels of MG-ADL improvement at week 26 (AChR+)³ , highlighting 68.1% of AChR+ patients receiving UPLIZNA had a ≥3 point improvement in MG ADL score (vs 48.9% of patients on placebo)

68.1% of anti-AChR Ab+ patients receiving UPLIZNA had a ≥3-point improvement in MG-ADL score (vs 48.9% of patients on placebo)5

≥3-point improvement in MG-ADL score in anti-AChR Ab+ patients was an additional secondary endpoint and depth of response is an exploratory analysis. Neither have been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

Ab+, antibody positive; AChR, acetylcholine receptor; MG-ADL, Myasthenia Gravis–Activities of Daily Living.

Proportion of participants with baseline steroid use of >5 mg/day who reduced steroid use to ≤5 mg/day at Week 26, n/N (%)4,*

Patients taking ≤5 mg/day of steroids4,5,*

Graph comparing baseline and week 26, showing that by week 26, 87% of patients on UPLIZNA were receiving <5mg/day of steroids (vs 85% on placebo)⁴

Mean dose of steroids:

  • Baseline: UPLIZNA, 17.0 mg/day; placebo, 18.8 mg/day2
  • Week 26: UPLIZNA, 5.4 mg/day; placebo, 5.5 mg/day6

Steroid use of ≤5 mg/day was an additional secondary endpoint and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

*Steroid use at Week 26 was calculated only in patients taking >5 mg/day at baseline.

The Myasthenia Gravis—Activities of Daily Living (MG-ADL) scale assesses the impact of gMG on daily functions6

Functional assessments include:6

  • Ocular
  • Bulbar
  • Respiratory
  • Limb

Impairment in each symptom is graded from 0 (normal) to 3 (most severe impairment). The scores are added together to provide a total from 0 to 24, with higher scores indicating more severe disease.2,6 A 2-point improvement in the MG-ADL score is considered a clinically meaningful improvement.2

gMG, generalized myasthenia gravis.

Depth of response with UPLIZNA vs placebo at 26 weeks in the anti-MuSK Ab+ population9

Exploratory Endpoint: Proportion of patients showing various levels of MG-ADL improvement at Week 26 (anti-MuSK Ab+)9

Exploratory Endpoint chart showing proportion of patients showing various levels of MG-ADL improvement at week 26 (AChR+)³, highlighting 70.8% of MuSK+ patients receiving UPLIZNA had a ≥3-point improvement in MG ADL score (vs 45.8% of patients on placebo)

70.8% of anti-MuSK Ab+ patients receiving UPLIZNA had a ≥3-point improvement in MG-ADL score (vs 45.8% of patients on placebo)9

≥3-point improvement in MG-ADL score in anti-MuSK Ab+ patients was an additional secondary endpoint and depth of response is an exploratory analysis. Neither have been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

Anti-MuSK Ab+, anti-muscle specific tyrosine kinase antibody positive; MG-ADL, Myasthenia Gravis—Activities of Daily Living.

  • Anti-AChR Ab+
  • Anti-MuSK Ab+

Both serotypes experienced significant improvement in MG-ADL through 26 weeks1
Change from baseline in MG-ADL score at Week 26 in anti-AChR Ab+ patients1,2

Line graph showing proportion of AChR+ patients showing various levels of MG-ADL difference throughout 26 weeks, UPLIZNA showing a 1.8 point difference compared to placebo Icon with a green border displaying the text: "1.8 point difference in MG-ADL vs placebo (P<0.002)²"
Line graph showing proportion of AChR+ patients showing various levels of MG-ADL difference throughout 26 weeks, UPLIZNA showing a 1.8 point difference compared to placebo - Icon with a green border displaying the text: "1.8 point difference in MG-ADL vs placebo (P<0.002)²"

Related charts

  • 68.1% of anti-AChR Ab+ patients receiving UPLIZNA had a ≥3-point improvement in MG-ADL score (vs 48.9% of patients on placebo)5

≥3-point improvement in MG-ADL score was an additional secondary endpoint and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.5

Ab+, antibody positive; AChR, acetylcholine receptor; MG-ADL, Myasthenia Gravis—Activities of Daily Living; MuSK, muscle specific tyrosine kinase.

Both serotypes experienced significant improvement in MG-ADL through 26 weeks1
Secondary Endpoint: Change from baseline in MG-ADL score at Week 26 in anti-MuSK Ab+ patients1,2

Line graph showing secondary endpoint change from baseline in MG-ADL score at Week 26 in anti-MuSK Ab+ patients Icon with a green border displaying the text: "2.2 point difference in MG-ADL vs placebo³"
Line graph showing secondary endpoint change from baseline in MG-ADL score at Week 26 in anti-MuSK Ab+ patients - Icon with a green border displaying the text: "2.2 point difference in MG-ADL vs placebo³"

Related charts

  • 70.8% of anti-MuSK Ab+ patients receiving UPLIZNA had a ≥3-point improvement in MG-ADL score (vs 45.8% of patients on placebo)5

≥3-point improvement in MG-ADL score in anti-MuSK Ab+ patients was an additional secondary endpoint that has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.

Ab+, antibody positive; AChR, acetylcholine receptor; MG-ADL, Myasthenia Gravis—Activities of Daily Living; MuSK, muscle specific tyrosine kinase.

  • MG-ADL
  • QMG

UPLIZNA offered deep, durable disease control that was sustained through 52 weeks in the RCP1
Exploratory Analysis: Change from baseline in MG-ADL score at Week 52 in anti-AChR Ab+ patients2

Exploratory Analyses line graph showing the change from baseline in MG-ADL score at week 52 in AChR+ patients 1-3, UPLIZNA showing a 2.8 point difference compared to placebo Icon with a green border displaying the text: "2.8 point difference in MG-ADL vs placebo³"
Exploratory Analyses line graph showing the change from baseline in MG-ADL score at week 52 in AChR+ patients 1-3, UPLIZNA showing a 2.8 point difference compared to placebo - Icon with a green border displaying the text: "2.8 point difference in MG-ADL vs placebo³"

Related charts

  • 72.3% of patients receiving UPLIZNA had a ≥3-point improvement in MG-ADL score (vs 45.2% of patients on placebo)9

Data at 52 weeks have not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.

Anti-AChR Ab+, anti-acetylcholine receptor antibody positive; CI, confidence interval; MG-ADL, Myasthenia Gravis—Activities of Daily Living;
RCP, randomized controlled period.

UPLIZNA offered deep, durable disease control that was sustained through 52 weeks in the RCP1
Exploratory Analysis: Change from baseline in QMG score at Week 52 in anti-AChR Ab+ patients2,4

Exploratory Analyses line graph showing the change from baseline in QMG score at week 52 in AChR Ab+ patients, UPLIZNA showing a 4.3 point difference compared to placebo Icon with a green border displaying the text: "4.3 point difference in QMG vs placebo4"
Exploratory Analyses line graph showing the change from baseline in QMG score at week 52 in AChR Ab+ patients, UPLIZNA showing a 4.3 point difference compared to placebo - Icon with a green border displaying the text: "4.3 point difference in QMG vs placebo4"

Related charts

  • 69.2% of patients receiving UPLIZNA had a ≥3-point difference in QMG score (vs 41.8% of patients on placebo)9

Data at 52 weeks have not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.

Ab+, antibody positive; AChR, acetylcholine receptor; MG-ADL, Myasthenia Gravis–Activities of Daily Living; MuSK, muscle specific tyrosine kinase; QMG, quantitative myasthenia gravis score.

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Proportion of participants with baseline steroid use of >5 mg/day who reduced steroid use to ≤5 mg/day at Week 26, n/N (%)4,*

Patients taking ≤5 mg/day of steroids4,5,*

Graph comparing baseline and week 26, showing that by week 26, 87% of patients on UPLIZNA were receiving <5mg/day of steroids (vs 85% on placebo)⁴

Mean dose of steroids:

  • Baseline: UPLIZNA, 17.0 mg/day; placebo, 18.8 mg/day2
  • Week 26: UPLIZNA, 5.4 mg/day; placebo, 5.5 mg/day6

Steroid use of ≤5 mg/day was an additional secondary endpoint and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

*Steroid use at Week 26 was calculated only in patients taking >5 mg/day at baseline.

The Myasthenia Gravis—Activities of Daily Living (MG-ADL) scale assesses the impact of gMG on daily functions6

Functional assessments include:6

  • Ocular
  • Bulbar
  • Respiratory
  • Limb

Impairment in each symptom is graded from 0 (normal) to 3 (most severe impairment). The scores are added together to provide a total from 0 to 24, with higher scores indicating more severe disease.2,6 A 2-point improvement in the MG-ADL score is considered a clinically meaningful improvement.2

gMG, generalized myasthenia gravis.

MINT 52-Week anti-AChR Ab+ Efficacy Outcomes: Various MG-ADL Scores9

Exploratory Endpoint: Proportion of patients showing various levels of MG-ADL improvement at Week 52 (anti-AChR Ab+)9

Exploratory Endpoint chart showing proportion of patients showing various levels of MG-ADL improvement at week 26 (AChR+)³ , highlighting 72.3% of AChR+ patients receiving UPLIZNA had a ≥3-point improvement in MG ADL score (vs 45.2% of patients on placebo) at 52 weeks

72.3% of anti-AChR Ab+ patients receiving UPLIZNA had a ≥3-point improvement in MG-ADL score (vs 45.2% of patients on placebo) at 52 weeks9

≥3-point improvement in MG-ADL score in anti-AChR Ab+ patients was an additional secondary endpoint and depth of response is an exploratory analysis. Neither have been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

Anti-AChR Ab+, anti-acetylcholine receptor antibody positive; MG-ADL, Myasthenia Gravis Activities of Daily Living; MINT, Myasthenia Gravis Inebilizumab Trial.

Proportion of participants with baseline steroid use of >5 mg/day who reduced steroid use to ≤5 mg/day at Week 26, n/N (%)4,*

Patients taking ≤5 mg/day of steroids4,5,*

Graph comparing baseline and week 26, showing that by week 26, 87% of patients on UPLIZNA were receiving <5mg/day of steroids (vs 85% on placebo)⁴

Mean dose of steroids:

  • Baseline: UPLIZNA, 17.0 mg/day; placebo, 18.8 mg/day2
  • Week 26: UPLIZNA, 5.4 mg/day; placebo, 5.5 mg/day6

Steroid use of ≤5 mg/day was an additional secondary endpoint and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

*Steroid use at Week 26 was calculated only in patients taking >5 mg/day at baseline.

Quantitative myasthenia gravis (QMG) score is a physician-reported standardized clinical tool used to assess the severity of gMG8

QMG assesses a range of 13 potential symptoms or functional limitations in several areas, including

  • Respiratory function
  • Bulbar function
  • Ocular function
  • Limb function

Each group is scored from 0 (normal) to 3 (severe impairment). The scores are added to provide a total from 0 to 39, with higher scores indicating more severe disease.8 The clinically meaningful improvement threshold for QMG score is generally considered to be a ≥3-point reduction from baseline.2

gMG, generalized myasthenia gravis.

MINT 52-Week Anti-AChR Ab+ Efficacy Outcomes: Various QMG Scores9

Exploratory Endpoint: Proportion of patients showing various levels of QMG improvement at Week 52 (Anti-AChR Ab+)9

Exploratory Endpoint chart showing proportion of patients showing various levels of QMG improvement at week 52 (AChR+)⁴ , highlighting 69.2% of AChR+ patients receiving UPLIZNA had a ≥3-point improvement in QMG score (vs 41.8% of patients on placebo) at 52 weeks

69.2% of Anti-AChR Ab+ patients receiving UPLIZNA had a ≥3-point improvement in QMG score (vs 41.8% of patients on placebo) at 52 weeks9

≥3-point improvement in QMG score in anti-AChR Ab+ patients was an additional secondary endpoint and depth of response is an exploratory analysis. Neither have been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.2

Anti-AChR Ab+, anti-acetylcholine receptor antibody positive; QMG, quantitative myasthenia gravis; MINT, Myasthenia Gravis Inebilizumab Trial.

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. UPLIZNA® (inebilizumab-cdon) prescribing information, Amgen.
    2. Nowak RJ, Benatar M, Ciafaloni E, et al. N Engl J Med. 2025;392(23):2309-2320.
    3. Data on File. Amgen; 2024.
    4. Nowak RJ, Benatar M, Ciafaloni E, et al. N Engl J Med. 2025(suppl):NEJMoa2501561.
    5. Data on File. Amgen; 2025.
    6. Nowak RJ, Utsugisawa K, Benatar M, et al. Poster presented at: Myasthenia Gravis Foundation of America; May 2025; the Hague, NL.
    7. Muppidi S, Silvestri NJ, Tan R, et al. Muscle and Nerve. 2021;65:630-639.
    8. Barnett C, Herberlin L, Dimachkie MM, et al. Neurol Clin. 2018;36(2):339-353.
    9. Nowak RJ, Utsugisawa K, Benatar M, et al. Presented at: American Academy of Neurology Annual Meeting; April 18-22, 2025; Chicago, IL.