FREQUENTLY ASKED QUESTIONS

Below are answers to some common questions about UPLIZNA® (inebilizumab-cdon). You can also discuss any of these questions with your doctor when considering UPLIZNA.

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

UPLIZNA is understood to work by lowering the level of B cells in the body. B cells help the body’s immune system to work. But if there are too many B cells, they may cause autoimmune diseases, such as NMOSD. UPLIZNA works to reduce the overactive immune response caused by B cells.

UPLIZNA is given as an intravenous (IV) infusion, meaning it goes directly into a vein. The first 2 infusions are given 2 weeks apart. After that, UPLIZNA is given every 6 months.

UPLIZNA is given to you by a healthcare provider. It can be given to you at an infusion center, a hospital, your doctor’s office, or even in your own home. Sometimes medicine given by IV can cause serious allergic reactions, so the healthcare provider will watch you closely. If a negative reaction occurs, you will be given medicine to stop it. The UPLIZNA infusion will be stopped.

Each infusion takes about 90 minutes. After your infusions, a healthcare provider will continue to watch you for 1 hour for signs of allergic reactions.

Once your infusion is over, you can return to your regular daily activities.

For adults with NMOSD, UPLIZNA is proven to reduce relapses (or repeat attacks) that may lead to permanent physical disability and to reduce NMOSD-related hospitalizations. Talk to your doctor to see if UPLIZNA is right for you.

Before receiving your first infusion of UPLIZNA, your doctor will need to perform health screenings, including checking for infections such as hepatitis B and tuberculosis.

You and your doctor will discuss if you are due for any vaccines. If so, you would need to get the vaccines at least 1 month before your first infusion of UPLIZNA.

UPLIZNA is given as an intravenous (IV) infusion, meaning it goes directly into a vein. The first 2 infusions are given 2 weeks apart. After that, UPLIZNA is given every 6 months.

In patient studies of UPLIZNA, some people experienced mild-to-moderate infusion reactions. These included headache, nausea, sleepiness, fever, muscle pain, or rash. To manage possible reactions, your doctor may prescribe medicines to reduce the risk of an allergic reaction.

UPLIZNA has a twice-yearly dosing schedule. The first 2 infusions of UPLIZNA are given 2 weeks apart. After that, UPLIZNA is given every 6 months. Each infusion takes about 90 minutes.

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.

It’s also important that your doctor is aware of your current medical information, such as:

  • New or worsening symptoms
  • Changes in your ability to do daily activities
  • Pain or discomfort
  • Any other concerns you may have

UPLIZNA should not be taken by people with:

  • A previous life-threatening reaction from receiving UPLIZNA
  • An active hepatitis B infection
  • An active tuberculosis infection

UPLIZNA should also not be taken by anyone who is pregnant or trying to become pregnant. All women of childbearing age should use contraception while receiving UPLIZNA and for 6 months after the last infusion.

Taking UPLIZNA at the same time as other drugs that suppress your immune system, such as corticosteroids, may increase the risk of infection.

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

In the N-MOmentum clinical trial, the side effects of UPLIZNA were similar to placebo. UPLIZNA may cause serious side effects, including low blood-cell count. The most common side effects were urinary tract infections, joint pain, headaches, and back pain.

Your doctor may give you medications before your infusions to prevent an allergic reaction. For more information about possible side effects, please see the Medication Guide.

The first step to getting started on UPLIZNA is to talk to your doctor to see if it’s right for you. If you need tips on getting that conversation started, see the Resources page for some questions to ask.

Before receiving your first infusion of UPLIZNA, your doctor will need to perform health screenings, including checking for infections such as hepatitis B and tuberculosis.

You and your doctor will discuss if you are due for any vaccines. If so, you must get these at least 1 month before starting UPLIZNA infusions. However, 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.

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HEAR FROM PATIENTS

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.