Infusion time of approximately 90 minutes1

graphgraph

See how the UPLIZNA infusion experience compares to other approved therapies in NMOSD

TREATMENT COMPARISON

  • Check Ig levels and test for hepatitis B virus prior to treatment administration1
  • Administer all vaccinations at least 4 weeks prior to initiation of UPLIZNA1
  • A corticosteroid, an antihistamine, and an antipyretic are given 30-60 minutes prior to administration to reduce infusion reactions and attacks1,3
Approved NMOSD Treatment UPLIZNA®
(inebilizumab-cdon)
SOLIRIS®
(eculizumab)
ENSPRYNG (satralizumab-mwge)
Mechanism of action CD19+ B-cell depletion Complement (anti-C5) Anti-IL-6R
Initial dose 2 doses over 2 weeks 5 doses over 5 weeks 2 doses over 1 month
Maintenance dose 2 doses per year 24 doses per year 12 doses per year
Mode of administration IV infusion IV infusion SC injection
Mechanism of action UPLIZNA®
(inebilizumab-cdon)
CD19+ B-cell
depletion
SOLIRIS®
(eculizumab)
Complement
(anti-C5)
ENSPRYNG
(satralizumab-mwge)
Anti-IL-6R
Initial dose UPLIZNA®
(inebilizumab-cdon)
2 doses over
2 weeks
SOLIRIS®
(eculizumab)
5 doses over
5 weeks
ENSPRYNG
(satralizumab-mwge)
2 doses over
1 month
Maintenance dose UPLIZNA®
(inebilizumab-cdon)
2 doses per year SOLIRIS®
(eculizumab)
24 doses per year ENSPRYNG
(satralizumab-mwge)
12 doses per year
Mode of administration UPLIZNA®
(inebilizumab-cdon)
IV infusion SOLIRIS®
(eculizumab)
IV infusion ENSPRYNG
(satralizumab-mwge)
SC injection

SC; subcutaneous.

Low infusion reaction rates similar to placebo3

UPLIZNA infusion reaction rate chart

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. 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.
  3. 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.