UPLIZNA SAFETY

IN THE RANDOMIZED CONTROLLED PERIOD

UPLIZNA HAS A DEMONSTRATED SAFETY AND TOLERABILITY PROFILE1

Adverse events (AEs) with an incidence of ≥5% with UPLIZNA and a greater incidence than placebo during the randomized controlled period

UPLIZNA adverse events graph
  • Low rates of treatment-emergent anti-UPLIZNA antibodies (5.6%)

In the randomized controlled period, serious adverse events were reported in 4% of patients on UPLIZNA vs 10% for placebo2

4%

UPLIZNA

VS Icon

10%

placebo

UPLIZNA had a similar adverse event rate compared to placebo in
the RCP1

IN PATIENTS TREATED WITH UPLIZNA AT ANY POINT DURING N-MOMENTUM

INFECTION RATES DID NOT INCREASE OVER 4+ YEARS OF TREATMENT3

Treatment-emergent infection rates (AQP4-IgG+ and AQP4-IgG– patients)

UPLIZNA safety incidence graph
  • This population includes both AQP4-IgG+ and – patients3
  • Most common treatment-emergent infections over 4+ years of observation were bronchitis, influenza, nasopharyngitis, URTI, and UTI3
  • Serious infections were rare and did not increase over time3

Treatment-emergent infection rates did not increase over time3

IN PATIENTS TREATED WITH UPLIZNA AT ANY POINT DURING N-MOMENTUM

LOWER IgG LEVELS WERE NOT ASSOCIATED WITH INCREASED INFECTION RISK OVER 4+ YEARS OF TREATMENT4

Infection status by lowest IgG titer in patients treated with UPLIZNA at any point during the triala

UPLIZNA risk graph

This population includes both AQP4-IgG+ and – patients4

Lower IgG levels did not correspond with increased infection risk4

<5%

of participants experienced IgG levels below 300 mg/dL4

aAlthough 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.6

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

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-cdon) [prescribing information] Horizon.
  2. Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised, placebo-controlled phase 2/3 trial. Lancet. 2019;394:1352-1363. doi:10.1016/S0140-6736(19)31817-3.
  3. Greenberg B, She D, Katz E, et al. Immunoglobulin kinetics and infection risk after long-term inebilizumab treatment for neuromyelitis optica spectrum disorder. Poster A-21-00372 presented at: The 7th Congress of the European Academy of Neurology (virtual); June 19-21, 2021.
  4. 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: The 7th Congress of the European Academy of Neurology (virtual); June 19-22, 2021.
  5. Viela Bio announces U.S. FDA Approval of UPLIZNATM (inebilizumab-cdon) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Press release. Viela Bio. June 11, 2020. Accessed July 7, 2021. https://www.globenewswire.com/news-release/2020/06/11/2047190/0/en/Viela-Bio-Announces-U-S-FDA-Approval-of-UPLIZNA-inebilizumab-cdon-for-the-Treatment-of-Neuromyelitis-Optica-Spectrum-Disorder-NMOSD.html.
  6. Rensel M, Zabeti A, Mealy MA, et al. Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: analysis of aquaporin-4-IgG seropositive participants taking inebilizumab for ≥4 years in the N-MOmentum trial. In press.