The UPLIZNA Difference WHY UPLIZNA?

Only UPLIZNA offers the combination of reducing the risk of NMOSD attacks with a dosing schedule that fits your lifestyle and an established safety profile supported by data from the largest NMOSD study. In a study, UPLIZNA demonstrated a 77% relative reduction in attacks (11% of patients on UPLIZNA had an attack through the first 28 weeks vs 42% on placebo).

NMOSD attack reduction buttonNMOSD attack reduction button

Two doses per year buttonTwo doses per year button

Proven safety profile buttonProven safety profile button

*Compared to 58% of patients on placebo in a study at 28 weeks.

†After 2 startup doses.

B CELLS: THE SCIENCE BEHIND THE DIFFERENCE

UPLIZNA is the first and only FDA-approved treatment for NMOSD that targets and destroys B cells at nearly all stages of their life cycle.

While B cells are the basis of the science behind UPLIZNA, there are other factors to consider. The table below is a snapshot of some of these factors across the NMOSD treatment landscape.

TREATMENT LANDSCAPE

All NMOSD medicines have different dosing schedules, ways they work, and support programs. Most of the information below is taken from each product’s full prescribing information, which is a document that describes important information about a drug and is approved by the FDA. Head-to-head studies were not done on the products below.
UPLIZNA® (inebilizumab-cdon) RITUXAN®
(rituximab)		 SOLIRIS®
(eculizumab)		 ULTOMIRIS® (ravulizumab-cwvz)
 ENSPRYNG® (satralizumab-mwge)
FDA approved based on studies in patients with NMOSD?‡ Yes No Yes Yes Yes
What is the size of the study that led to FDA approval? 230 patients N/A 143 patients 58 patients§ 171 patients‖
How many starting doses? 2 doses over 2 weeks Varies by use 5 doses over 5 weeks 1 starting dose 3 doses over
1 month
How many maintenance doses each year? 2 per year 2 per year 26 per year 6-7 per year 13 per year
How is it understood to work? Anti-CD19+
(B-cell depletion)		 Anti-CD20+
(B-cell depletion)		 C5 inhibitor C5 inhibitor IL-6 inhibition
Does it destroy B cells at nearly all stages? Yes No N/A N/A N/A
How is it administered? 90-minute infusion 3 to 4+ hour infusion 35-minute infusion About 1 hour infusion Injection under the skin
Co-pay support?# Yes No Yes Yes Yes
FDA approved based on studies in patients with NMOSD?‡ UPLIZNA® (inebilizumab-cdon) Yes RITUXAN®
(rituximab)		 No SOLIRIS®
(eculizumab)		 Yes ULTOMIRIS®
(ravulizumab-cwvz)		 Yes ENSPRYNG®
(satralizumab-mwge)		 Yes
What is the size of the study that led to FDA approval? UPLIZNA® (inebilizumab-cdon) 230 patients RITUXAN®
(rituximab)		 N/A SOLIRIS®
(eculizumab)		 143 patients ULTOMIRIS®
(ravulizumab-cwvz)		 58 patients§ ENSPRYNG®
(satralizumab-mwge)		 171 patients‖
How many starting doses? UPLIZNA®
(inebilizumab-cdon)		 2 doses over
2 weeks		 RITUXAN®
(rituximab)		 Varies by use SOLIRIS®
(eculizumab)		 5 doses over
5 weeks		 ULTOMIRIS®
(ravulizumab-cwvz)		 1 starting dose ENSPRYNG®
(satralizumab-mwge)		 3 doses over
1 month
How many maintenance doses each year? UPLIZNA®
(inebilizumab-cdon)		 2 per year RITUXAN®
(rituximab)		 2 per year SOLIRIS®
(eculizumab)		 26 per year ULTOMIRIS®
(ravulizumab-cwvz)		 6-7 per year ENSPRYNG®
(satralizumab-mwge)		 13 per year
How is it understood to work? UPLIZNA®
(inebilizumab-cdon)		 Anti-CD19+
(B-cell depletion)		 RITUXAN®
(rituximab)		 Anti-CD20+
(B-cell depletion)		 SOLIRIS®
(eculizumab)		 C5 inhibitor ULTOMIRIS®
(ravulizumab-cwvz)		 C5 inhibitor ENSPRYNG®
(satralizumab-mwge)		 IL-6 inhibition
Does it destroy B cells at nearly all stages? UPLIZNA®
(inebilizumab-cdon)		 Yes RITUXAN®
(rituximab)		 No SOLIRIS®
(eculizumab)		 N/A ULTOMIRIS®
(ravulizumab-cwvz)		 N/A ENSPRYNG®
(satralizumab-mwge)		 N/A
How is it administered? UPLIZNA®
(inebilizumab-cdon)		 90-minute
infusion		 RITUXAN®
(rituximab)		 3 to 4+ hour
infusion		 SOLIRIS®
(eculizumab)		 35-minute
infusion		 ULTOMIRIS®
(ravulizumab-cwvz)		 About 1 hour
infusion		 ENSPRYNG®
(satralizumab-mwge)		 Injection under
the skin
Co-pay support?# UPLIZNA®
(inebilizumab-cdon)		 Yes RITUXAN®
(rituximab)		 No SOLIRIS®
(eculizumab)		 Yes ULTOMIRIS®
(ravulizumab-cwvz)		 Yes ENSPRYNG®
(satralizumab-mwge)		 Yes

‡FDA approval means that the FDA has determined that the medication is effective for its intended use. The benefits of the medication are greater than its risks when used as intended.

§Placebo group data (n=47) were also collected as part of a previously conducted trial.

||Total number of patients between 2 studies: 95 patients in SakuraStar and 76 patients in SakuraSky.

Dosing may be determined by prescriber.

#For eligible commercial patients. See individual terms and conditions.

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IMPORTANT SAFETY INFORMATION

What is UPLIZNA?

UPLIZNA is a prescription medicine used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

It is not known if UPLIZNA is safe or effective in children.

Who should not receive UPLIZNA?

You should not receive UPLIZNA if you have:

  • had a life-threatening infusion reaction to UPLIZNA.
  • an active hepatitis B virus infection.
  • active or untreated inactive (latent) tuberculosis.

Before receiving UPLIZNA, tell your healthcare provider about all of your medical conditions, including if you:

  • have or think you have an infection.
  • have ever taken, currently take, or plan to take medicines that affect your immune system, or other treatments for NMOSD. These medicines may increase your risk of getting an infection.
  • have or have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • have or have ever had tuberculosis.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required vaccines at least 4 weeks before you start treatment with UPLIZNA.
  • are pregnant or plan to become pregnant. It is not known if UPLIZNA will harm your unborn baby. Females should use birth control (contraception) during treatment with UPLIZNA and for 6 months after your last infusion of UPLIZNA.
  • are breastfeeding or plan to breastfeed. It is not known if UPLIZNA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive UPLIZNA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What is the most important information I should know about UPLIZNA?

UPLIZNA may cause serious side effects, including:

Infusion reactions. UPLIZNA can cause infusion reactions that can be serious or may cause you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of UPLIZNA for signs and symptoms of an infusion reaction. Tell your healthcare provider right away if you get any of these symptoms:

  • headache
  • sleepiness
  • fever
  • rash
  • nausea
  • shortness of breath
  • muscle aches

If you develop an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion and treat your symptoms.

Infections. Infections can happen during treatment with UPLIZNA. Tell your healthcare provider right away if you have an infection or get any of these symptoms:

    • painful and frequent urination
    • nasal congestion, runny nose, sore throat, fever, chills, cough, body aches
  • UPLIZNA taken before or after other medicines that weaken the immune system may increase your risk of getting infections.
  • Hepatitis B virus (HBV) reactivation. Before starting treatment with UPLIZNA, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with UPLIZNA. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving UPLIZNA.
  • Progressive Multifocal Leukoencephalopathy (PML). PML may happen with UPLIZNA. PML is a rare brain infection that leads to death or severe disability. Symptoms of PML may get worse over days to weeks. Call your healthcare provider right away if you get any of these symptoms:
    • weakness on one side of the body
    • changes in your vision
    • confusion
    • loss of coordination in your arms and legs
    • changes in thinking or memory
    • changes in your personality
  • Tuberculosis (TB). TB is caused by an infection in the lungs. Before starting treatment with UPLIZNA, your healthcare provider will check to see if you are at risk for getting TB or have ever had TB.
  • Vaccinations. Certain vaccines, called “live” or “live attenuated” vaccines, are not recommended in people receiving UPLIZNA. Talk to your healthcare provider before receiving any vaccinations. If you have a baby and you were receiving UPLIZNA during pregnancy, it is important to tell your baby’s healthcare provider about your UPLIZNA use so they can decide when your baby should receive any vaccine.

See “What are the possible side effects of UPLIZNA?” for more information about side effects.

How will I receive UPLIZNA?

  • UPLIZNA is given through a needle placed in a vein (IV or intravenous infusion) in your arm.
  • Before treatment with UPLIZNA, your healthcare provider will give you a corticosteroid medicine, an antihistamine, and a fever prevention medicine to help infusion reactions become less frequent and less severe. See “What is the most important information I should know about UPLIZNA?”
  • Your first dose of UPLIZNA will be given as 2 separate infusions, 2 weeks apart.
  • Your next doses of UPLIZNA will be given as one infusion every 6 months.
  • Each infusion will last about 1 hour and 30 minutes. After each infusion, you will be monitored by a healthcare provider for at least 1 hour.

What are the possible side effects of UPLIZNA?
UPLIZNA may cause serious side effects, including:

  • See “What is the most important information I should know about UPLIZNA?”
  • low blood cell counts. UPLIZNA may cause a decrease in some types of blood cells. Your healthcare provider will do blood tests to check your blood cell counts.

The most common side effects include urinary tract infection and joint pain.
These are not all the possible side effects of UPLIZNA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION

What is UPLIZNA?

UPLIZNA is a prescription medicine used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

It is not known if UPLIZNA is safe or effective in children.

Who should not receive UPLIZNA?

You should not receive UPLIZNA if you have:

  • had a life-threatening infusion reaction to UPLIZNA.
  • an active hepatitis B virus infection.
  • active or untreated inactive (latent) tuberculosis.

Before receiving UPLIZNA, tell your healthcare provider about all of your medical conditions, including if you:

  • have or think you have an infection.
  • have ever taken, currently take, or plan to take medicines that affect your immune system, or other treatments for NMOSD. These medicines may increase your risk of getting an infection.
  • have or have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • have or have ever had tuberculosis.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required vaccines at least 4 weeks before you start treatment with UPLIZNA.
  • are pregnant or plan to become pregnant. It is not known if UPLIZNA will harm your unborn baby. Females should use birth control (contraception) during treatment with UPLIZNA and for 6 months after your last infusion of UPLIZNA.
  • are breastfeeding or plan to breastfeed. It is not known if UPLIZNA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive UPLIZNA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What is the most important information I should know about UPLIZNA?

UPLIZNA may cause serious side effects, including:

Infusion reactions. UPLIZNA can cause infusion reactions that can be serious or may cause you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of UPLIZNA for signs and symptoms of an infusion reaction. Tell your healthcare provider right away if you get any of these symptoms:

  • headache
  • sleepiness
  • fever
  • rash
  • nausea
  • shortness of breath
  • muscle aches

If you develop an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion and treat your symptoms.

Infections. Infections can happen during treatment with UPLIZNA. Tell your healthcare provider right away if you have an infection or get any of these symptoms:

    • painful and frequent urination
    • nasal congestion, runny nose, sore throat, fever, chills, cough, body aches
  • UPLIZNA taken before or after other medicines that weaken the immune system may increase your risk of getting infections.
  • Hepatitis B virus (HBV) reactivation. Before starting treatment with UPLIZNA, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with UPLIZNA. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving UPLIZNA.
  • Progressive Multifocal Leukoencephalopathy (PML). PML may happen with UPLIZNA. PML is a rare brain infection that leads to death or severe disability. Symptoms of PML may get worse over days to weeks. Call your healthcare provider right away if you get any of these symptoms:
    • weakness on one side of the body
    • changes in your vision
    • confusion
    • loss of coordination in your arms and legs
    • changes in thinking or memory
    • changes in your personality
  • Tuberculosis (TB). TB is caused by an infection in the lungs. Before starting treatment with UPLIZNA, your healthcare provider will check to see if you are at risk for getting TB or have ever had TB.
  • Vaccinations. Certain vaccines, called “live” or “live attenuated” vaccines, are not recommended in people receiving UPLIZNA. Talk to your healthcare provider before receiving any vaccinations. If you have a baby and you were receiving UPLIZNA during pregnancy, it is important to tell your baby’s healthcare provider about your UPLIZNA use so they can decide when your baby should receive any vaccine.

See “What are the possible side effects of UPLIZNA?” for more information about side effects.

How will I receive UPLIZNA?

  • UPLIZNA is given through a needle placed in a vein (IV or intravenous infusion) in your arm.
  • Before treatment with UPLIZNA, your healthcare provider will give you a corticosteroid medicine, an antihistamine, and a fever prevention medicine to help infusion reactions become less frequent and less severe. See “What is the most important information I should know about UPLIZNA?”
  • Your first dose of UPLIZNA will be given as 2 separate infusions, 2 weeks apart.
  • Your next doses of UPLIZNA will be given as one infusion every 6 months.
  • Each infusion will last about 1 hour and 30 minutes. After each infusion, you will be monitored by a healthcare provider for at least 1 hour.

What are the possible side effects of UPLIZNA?
UPLIZNA may cause serious side effects, including:

  • See “What is the most important information I should know about UPLIZNA?”
  • low blood cell counts. UPLIZNA may cause a decrease in some types of blood cells. Your healthcare provider will do blood tests to check your blood cell counts.

The most common side effects include urinary tract infection and joint pain.
These are not all the possible side effects of UPLIZNA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.