What is UPLIZNA® (inebilizumab-cdon)?
UPLIZNA is a prescription medicine used to treat adults with: Neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive; Immunoglobulin G4-related disease (IgG4-RD); Generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. It is not known if UPLIZNA is safe or effective in children.
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Below are answers to some common questions about UPLIZNA® (inebilizumab-cdon). You can also discuss these questions with your doctor when learning about UPLIZNA.

About gMG

  • What is gMG?
    Generalized myasthenia gravis (gMG) is a lifelong disease that requires ongoing treatment. It is a rare condition where the immune system targets the body’s own tissues, resulting in muscle weakness and fatigue.  
  • What are the symptoms of gMG?
    • Eyelid drooping 
    • Blurred or double vision 
    • Weakness in arms and hands 
    • Difficulty standing and walking 
    • Difficulty speaking 
    • Difficulty chewing and/or swallowing 
    • Difficulty breathing
    Symptoms vary from person to person. Without effective disease control, symptoms can disappear and reappear.

About UPLIZNA

  • What is UPLIZNA?
    UPLIZNA is an FDA-approved prescription medicine used to treat adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. It is not known if UPLIZNA is safe or effective in children. 
  • Who should not take UPLIZNA?
    UPLIZNA should not be taken by people with: 
    • A previous life-threatening reaction from receiving UPLIZNA 
    • An active hepatitis B infection 
    • An active or untreated inactive 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. 
  • How does UPLIZNA work?
    UPLIZNA is thought to work by targeting and reducing CD19 B cells, lowering the production of autoantibodies—proteins that attack healthy parts of the body. By reducing B cells at nearly all stages of their life cycle, UPLIZNA addresses a key source of gMG. The exact mechanism by which UPLIZNA works in gMG is unknown.

Starting Treatment on UPLIZNA

  • How can I get started on UPLIZNA?
    The first step to getting started on UPLIZNA is to talk to your doctor and see if it’s right for you. If you need tips on getting that conversation started, see the Partner With Your Doctor page for some questions to ask about gMG and UPLIZNA.
  • What should I expect when I receive UPLIZNA?

    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.

    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, nausea, sleepiness, shortness of breath, fever, muscle aches, or rash.

    To manage possible reactions, your doctor will give you medicines to reduce the risk of an infusion reaction. 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.

Considering Treatment With UPLIZNA

  • Can UPLIZNA work for me?
    UPLIZNA is proven to improve daily activities and reduce muscle weakness in adults with anti-AChR or anti-MuSK antibody positive gMG. Talk to your doctor to see if UPLIZNA is right for you. Patients taking UPLIZNA had a 4.2 point improvement in MG-ADL score vs a 2.2 point improvement for patients on placebo. Patients taking UPLIZNA also had a 4.8 point improvement in muscle weakness according to the QMG scale vs a 2.3 point improvement on placebo.
  • 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 gMG. 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 1 month 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 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 have 
  • How often do I need to receive UPLIZNA?
    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.
  • What are most common side effects of UPLIZNA?

    UPLIZNA may cause serious side effects. The most common side effects include headaches and infusion-related reaction.

    These are not all the possible side effects of UPLIZNA. For more information about possible side effects, please see the Medication Guide. If you think you're having a side effect, talk to your doctor or treatment team right away.

  • Are there any necessary tests or vaccines needed before starting UPLIZNA?

    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. 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.

Support & Resources

  • What is Amgen By Your Side?
    Amgen By Your Side is a personalized support program for patients prescribed UPLIZNA. Once enrollment is complete, patients will be paired with a dedicated support partner, called a Patient Access Liaison (PAL). The PAL will serve as a partner, providing resources outside of your doctor to help you navigate your unique experience—including information on insurance, financial support options, upcoming appointments, and other patient support services.
  • Who are Patient Access Liaisons (PALs)?

    The Amgen By Your Side Team is led by a Patient Access Liaison (PAL). Your PAL is a dedicated support partner who helps investigate, explain, and educate on the steps in your treatment experience. They are your partner to support and champion you while accomplishing your treatment goals. 

    Your PAL can educate and assist you in 

    • Learning about insurance coverage criteria and approval process 
    • Understanding financial support options
    • Understanding infusion appointment-related information 
    • Discussing what to expect at the start of treatment 
    • Determining how treatment, as prescribed, can fit into your routine
    • Receiving reminders to help you stay on UPLIZNA, as prescribed 
    • Discovering ways to connect with others, if interested 
    • Providing information about additional resources or advocacy groups 

    Once you’re signed up, you’ll get a welcome call from a Patient Access Liaison. After that, you can call, text, or email your PAL whenever you have nonmedical questions. You’ll have the same PAL throughout your treatment.

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IMPORTANT SAFETY INFORMATION

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.

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, including anaphylaxis, 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
  • palpitations

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.

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, IgG4-RD or gMG. 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 are the possible side effects of UPLIZNA?

UPLIZNA may cause serious side effects, including:

  • 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 in patients with NMOSD; urinary tract infection and low white blood cell count in patients with IgG4-RD; headache and infusion-related reaction in patients with gMG. 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.

What is UPLIZNA® (inebilizumab-cdon)?

UPLIZNA is a prescription medicine used to treat adults with: Neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive; Immunoglobulin G4-related disease (IgG4-RD); Generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. It is not known if UPLIZNA is safe or effective in children.

Please see UPLIZNA full Prescribing Information, including Medication Guide.

IMPORTANT SAFETY INFORMATION

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.

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, including anaphylaxis, 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
  • palpitations

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.

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, IgG4-RD or gMG. 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 are the possible side effects of UPLIZNA?

UPLIZNA may cause serious side effects, including:

  • 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 in patients with NMOSD; urinary tract infection and low white blood cell count in patients with IgG4-RD; headache and infusion-related reaction in patients with gMG. 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.

What is UPLIZNA® (inebilizumab-cdon)?

UPLIZNA is a prescription medicine used to treat adults with: Neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive; Immunoglobulin G4-related disease (IgG4-RD); Generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. It is not known if UPLIZNA is safe or effective in children.

Please see UPLIZNA full Prescribing Information, including Medication Guide.