Safety and Tolerability

UPLIZNA has a safety and tolerability profile similar to placebo1

During the RCP, the only AEs with an incidence of ≥ 10% and seen more frequently with UPLIZNA than with placebo were urinary tract infection and arthralgia1

AE Rates
Infection Rates
IgG Levels
Infusion-Related Reactions

AE Rates
UPLIZNA side effects graph, showing UTIs affecting 11% of patients, arthralgia affecting 10% of patients, headaches affecting 8% of patients, and back pain affecting 7% of patients UPLIZNA side effects graph, showing UTIs affecting 11% of patients, arthralgia affecting 10% of patients, headaches affecting 8% of patients, and back pain affecting 7% of patients UPLIZNA side effects graph, showing UTIs affecting 11% of patients, arthralgia affecting 10% of patients, headaches affecting 8% of patients, and back pain affecting 7% of patients
  • In the AQP4-IgG+ population, rates of serious AEs with UPLIZNA were lower than those with placebo (4% vs 10%, respectively)2
  • Patients on UPLIZNA demonstrated no new safety signals over 4+ years3
  • UPLIZNA was generally well tolerated over long-term treatment (4+ years, n=75), with few dose interruptions due to AEs (5.3%) and minimal treatment discontinuations3

Infection Rates

Infection rates remained low over 4+ years3,4

Infection rates did not increase after the first year of treatment with UPLIZNA3,4
Treatment-emergent infection rates3,4b
UPLIZNA treatment-emergent infection rate chart showing incidence/person-year, with diminishing infection rates over time UPLIZNA treatment-emergent infection rate chart showing incidence/person-year, with diminishing infection rates over time UPLIZNA treatment-emergent infection rate chart showing incidence/person-year, with diminishing infection rates over time

IgG Levels

Over 4+ years, lower IgG levels were not associated with increased risk of infection5
Infection status by lowest IgG titer5b,c
Chart showing infection status by lowest IgG titer Chart showing infection status by lowest IgG titer Chart showing infection status by lowest IgG titer
  • Few patients (< 5%) treated with UPLIZNA had very low IgG levels (< 300 mg/dL)4,5

Infusion-Related Reactions

Patients on UPLIZNA experienced a low rate of infusion-related reactions2
Rates of infusion-related reactions in
AQP4-IgG+ patients in the RCP2
Chart showing rates of infusion-related reactions in AQP4-IgG+ patients in the RCP, with placebo (n=52) at 10% and UPLIZNA (n=161) at 9% Chart showing rates of infusion-related reactions in AQP4-IgG+ patients in the RCP, with placebo (n=52) at 10% and UPLIZNA (n=161) at 9% Chart showing rates of infusion-related reactions in AQP4-IgG+ patients in the RCP, with placebo (n=52) at 10% and UPLIZNA (n=161) at 9%

In the RCP and OLP:

  • 99.5% of UPLIZNA infusions were completed without interruption over the 4+ years of the N-MOmentum trial6
  • All infusion-related reactions with UPLIZNA were Grade 1 or 2; only 1 infusion-related reaction (an incidence of migraine) was
    deemed serious7

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aAQP4-IgG+ population.1,2

bIncludes both AQP4-IgG+ and AQP4-IgG negative patients.5

cAlthough the lowest categories of IgG levels reported among participants were not significantly correlated with infection risk, the rate of severe infections was low and may not have been sufficient to rule out correlation.

AE, adverse event; AQP4-IgG–, aquaporin-4-immunoglobulin G negative; AQP4-IgG+, aquaporin-4-immunoglobulin G positive; OLP, open-label period; RCP, randomized controlled period; URTI, upper respiratory tract infection; UTI, urinary tract infection.

Tx Recommendations

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

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.

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

  • A history of life-threatening infusion reaction to UPLIZNA
  • Active hepatitis B infection
  • Active or untreated latent tuberculosis

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. 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 anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (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. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction 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 level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

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.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

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.

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

  • A history of life-threatening infusion reaction to UPLIZNA
  • Active hepatitis B infection
  • Active or untreated latent tuberculosis

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. 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 anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (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. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction 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 level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

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.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

  1. UPLIZNA (inebilizumab) [prescribing information] Horizon.
  2. Cree BAC, Bennett JL, Kim HJ, et al; N-MOmentum study investigators. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised, placebo-controlled phase 2/3 trial. Lancet. 2019;394(10206):1352-1363. doi:10.1016/S0140-6736(19)31817-3
  3. Rensel M, Zabeti A, Mealy MA, et al. Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4–immunoglobulin G-seropositive participants taking inebilizumab for ≥ 4 years in the N-MOmentum trial. Mult Scler. 2021;28(6):925-932. doi:10.1177/13524585211047223
  4. Greenberg B, She D, Katz E, Cree BAC. Immunoglobulin kinetics and infection risk after long-term inebilizumab treatment for neuromyelitis optica spectrum disorder. Poster A-21-00372 presented at: 7th Congress of the European Academy of Neurology (virtual); June 19-21, 2021.
  5. Cree BAC, Bennett JL, Weinshenker BG, et al. Long-term safety outcomes with inebilizumab treatment in neuromyelitis optica spectrum disorder: the N-MOmentum trial. Poster A-21-00373 presented at: 7th Congress of the European Academy of Neurology (virtual); June 19-22, 2021.
  6. Tullman M, Ratchford J, She D, et al. Evaluation of infusion rections and infusion times in the N-MOmentum study of inebilizumab for NMOSD. Poster P1941 presented at: 2021 American Academy of Neurology (AAN) meeting (virtual): April 17-22, 2021.
  7. Data on File. Horizon; June 2020.