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.

What is Uplizna?

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

How does Uplizna work?

B cells are important cells in the body’s immune system, but are also thought to be a potential cause of autoimmune diseases like NMOSD. Uplizna is believed to work by lowering the levels of B cells in the body, which may reduce the overactive immune response found in individuals with NMOSD.

How is Uplizna administered?

Uplizna is an intravenous (IV) infusion given on a twice-yearly dosing schedule (after two start-up doses).

Uplizna must be administered under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage potential severe reactions such as serious infusion reactions.

Each infusion will last about 90 minutes. After each infusion, you will be monitored by a healthcare provider for at least one hour.

Can Uplizna help my NMOSD?

For adults with NMOSD, Uplizna is proven to reduce relapses that may lead to permanent disability and to reduce NMOSD-related hospitalizations. Talk to your doctor to see if Uplizna is right for you.

What should I expect when Uplizna is administered?

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

Your doctor will also let you know if you need any immunizations. You will need to receive these at least a month in advance of your first infusion.

Uplizna is an IV infusion given on a twice-yearly dosing schedule. After your first two start-up doses, you’ll receive Uplizna twice a year, in approximately 90-minute infusions.

In the clinical trial for Uplizna, some people experienced mild-to-moderate infusion reactions, such as headache, nausea, sleepiness, fever, muscle pain or rash. To manage possible reactions, your doctor may prescribe premedications, such as steroids, antihistamines and antifever medications.

How often do I need to receive Uplizna?

Uplizna has a twice-yearly dosing schedule. After your first two start-up doses, you’ll receive Uplizna twice a year, in approximately 90-minute infusions.

What should I tell my doctor before starting Uplizna?

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 four 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 six 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

Who should not take Uplizna?

Uplizna should not be taken by people with:

  • A previous life-threatening reaction to infusion of Uplizna
  • An active hepatitis B infection
  • An active tuberculosis infection

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

Are there any medications I shouldn’t take while on Uplizna?

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.

What are the possible side effects of Uplizna?

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. For more important information about possible serious side effects, please see Medication Guide.

The most common side effects were urinary tract infections (11%), joint pain (10%), headaches (8%) and back pain (7%).

Your doctor may give you premedication before your infusion to manage any possible infusion reactions.

How can I get started on Uplizna?

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. You can also print out the Patient Referral Form—and take it to your doctor to talk about whether Uplizna is right for you.

Are there any necessary tests or vaccines needed before starting Uplizna?

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

Your doctor will also let you know if you need any immunizations. You will need to receive these at least a month in advance of your first infusion. 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.

Questions?

How Uplizna Works

Uplizna can help reduce relapses that may lead to permanent disability.

See clinical study results
Two times a year

Twice-yearly Dosing With Uplizna

Uplizna is the only treatment for NMOSD that is administered twice a year (after initial two start-up doses).

Get info about infusions
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.