We Chose UPLIZNA

Mary: In January of 2016, I thought I might have the flu. The pain started getting really intense around my midsection. And then at some point, I lost all feeling below my waist. We went to the emergency room and they admitted me to the hospital and they explained to me that what I had was neuromyelitis optica spectrum disorder.

Narrator: Neuromyelitis optica spectrum disorder, or NMOSD, is a rare, lifelong autoimmune disease caused by inflammation in the central nervous system (CNS), which is made up of the optic nerve, brain stem and spinal cord.

Mary: I thought, "Does this mean I'm going to be in a wheelchair the rest of my life?" And that was, that was overwhelming. The biggest fright was that I would not be able to continue to be active outside with the hiking and the stuff that I have done all my life. There were a lot of times that I thought, "What if I can't keep walking stronger? What if I never can go out in solitude, what would I do?"

I'll tell you, honestly, I never came up with an answer for that. All I could think of is being frightened that I might not be able to, and that would just make me more determined to try harder to do it. So I went to Houston to see the neurologist and through that appointment they determined that I was going to be a candidate for a drug that is now known as UPLIZNA.

Narrator: UPLIZNA is an FDA-approved prescription medicine used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. After beginning treatment with UPLIZNA, Mary noticed she wasn't experiencing any NMOSD relapses. She was able to be active again.

Mary: Even when I could just walk around one block, it was like victory, you know, I've done this. Eventually I was able to walk without the cane and I kept doing that. I think probably the biggest boon to my spirit was my first camping trip to try and set my tent up by myself. And it was slower, but it was absolutely doable. But then I could also take easy trails, and that was like, my life outdoors and the things I really treasure and love, that soul food of mine is not gone. My great grandson was hunting Easter eggs and he grabbed my hand and said, "[Grandma], let's just run." And so, you know, I can't run, but I can run as fast as he can run. So that’s really everything to me. That's complete joy, pure and complete joy. Being able to do that with those kids.

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.

Christine: I work five days a week, full time. I'm a manager at the veterinary office I work at and also a technician. Back in 2004, I was on a trip for work, and I started having a strange feeling in my leg. It was like it wasn't listening to what my brain was telling it to do. I made an appointment with my neurologist, and he just said I pulled my back and told me to do exercises. He ignored my symptoms and my pleas and it took about a month for me to get an MRI on my back. They had thought I had a spinal cord tumor, and they admitted me because I was becoming paralyzed very quickly. And I spent two weeks in the hospital.

They discharged me from the hospital, but I had to move out of my apartment move back in with my parents. They had to drive me to physical therapy three days a week. And then, I struggled. I learned to walk again, learn to do things on my own. Finally, about a year into not knowing what's going on, I was tested and my neurologist called me back into the office and told me I had NMOSD.

Narrator: Neuromyelitis optica spectrum disorder, or NMOSD, is a rare, lifelong autoimmune disease caused by inflammation in the central nervous system (CNS), which is made up of the optic nerve, brain stem and spinal cord.

Christine: After I was diagnosed, the doctors really didn't tell me much because they really didn't know what to expect. It was so rare. It was very scary. I didn't know what was going to happen.

Narrator: After her diagnosis, Christine tried many different infusions and medicines. None seemed to work for her. Her doctor then suggested a new medicine…UPLIZNA.

Christine: When my doctor first brought up UPLIZNA to me he told me it was an IV infusion that depleted your B cells. The first time it's given two doses, I think, two weeks apart. And then after that, it's just one infusion every six months. I decided that it would be worth it to try UPLIZNA because it fit my lifestyle. Today, being on UPLIZNA, I feel much more confident in living my life. I can travel. I do a lot of activities. I haven't had any attacks. I just started a small business last year. I make custom dog collars and I sell them on the Internet and go to local craft shows and sell them. I never thought I would be so confident in looking forward to the future. UPLIZNA has changed that.

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.

Michelle: I live in Illinois with my family. We have a farm and I have two small girls that are in school and work at a university as a college professor. It really hit in July of 2020, during the pandemic. And, I ended up with shingles. Those symptoms just kept going on for about two months. Itching, rash, I even got to the point where I was having nausea each day. And no answers.

It was just, "Take some anti-nausea pills." It was, it was very frustrating. When you live on a farm, you work hard, and to not work hard is kind of seen as laziness. And so I felt lazy. I felt like I couldn't support my family. I was asking my husband for a lot of help because I was too nauseous to even cook dinner. As a college professor, I wanted to have energy in the classroom and I just felt sick all the time.

It was very, very frustrating for those three months. It wasn't until October, that I woke up one morning and in this eye there was just a little spot that was fuzzy. And went to an ophthalmologist and they did a visual field test. And that visual field test showed that I had optic neuritis. What scared me the most about this optic neuritis is she said, "This could be your new normal." She said, "It may not go away."

She sent me to the neuro-ophthalmologists because they are the specialists, with eye diseases and other eye disorders. And I told him all of my symptoms. I told him all about the nausea. I told him all about the tingling in my skin, told him about the shingles, and it was like a light bulb clicked for him and he ordered a blood test. Two weeks later, I get the results and he said, "You have neuromyelitis optica."

Narrator: Michelle was diagnosed with neuromyelitis optica spectrum disorder or NMOSD, a rare, lifelong autoimmune disease caused by inflammation in the central nervous system (CNS), which is made up of the optic nerve, brain stem and spinal cord.

Her neuro-ophthalmologist immediately started her on treatment, but she continued to have relapses.

Michelle: I woke up one morning. This was my first relapse of the disease. It was about six months after my diagnosis, so I was doing good. I woke up and I just *hiccup, hiccup, hiccup,* I couldn't stop. And it lasted an hour. And then another hour later they start back up again. So they just kept going. Then I started vomiting, and that didn't stop. The relationship I had with my neuro-ophthalmologist was unlike one I'd had with any other doctor before.

NMO is such a rare disease that he actually gave me his cell phone number. So about three days into this, I call him and he said, "Yes, that is actually a relapse." Then my second relapse, the last one I've had, was in 2021. I had vertigo. This was all day, constant vertigo for a week. And so when I went to the hospital, that ended up being a five day stay. Longest I'd ever been in the hospital before.

At that point my neuro-ophthalmologist said, "You shouldn't be having relapses every two months." So, he actually referred me to another doctor who was more of a specialist. He gave me some brochures with the FDA-approved options for NMO. And, he talked me through each one and I was able to make a decision based on kind of the pros and cons of each one, and which one would work best for me.

Narrator: Together, Michelle and her doctor decided the best option for her was UPLIZNA. UPLIZNA is the only FDA-approved NMOSD therapy with treatment just two times a year, following two initial doses.

Michelle: The draw to UPLIZNA was absolutely the once every six month infusion. So with UPLIZNA, the doctor walked me through the potential side effects. But with any medication, there are side effects. And I felt like it was still worth going through the treatment based on the dosing schedule. That's really what I was looking for. And the data looked good. The data he was showing me was that there were a lot of patients that did not have relapses. And so that was intriguing. You know, I'd had three at this point and I was ready to try something.

After taking UPLIZNA, I have not had a relapse since. Is every day perfect? No, I still have days I'm tired. I still have days where I might have some nerve pain. I go to work, I teach my classes, I have my energy like I always do. I come home, I take my kids to scouting events, to church events. You know, I can be the mom I want to be. I can help out on the farm. And, UPLIZNA is part of that. Absolutely.

We went on vacation last year and I didn't have that worry that we would have to find a hospital somewhere. We're going on vacation this summer. My husband and I are thinking about going overseas next year for our 15th anniversary. And three years ago, I would have been very worried about doing that. Before, I felt like NMOSD was controlling me, and after starting treatments, it was the opposite. Rather than NMOSD controlling me, I felt like I was controlling it. That this medicine was helping me live the life I wanted to at work, with my family. As someone who likes some control in her life, it was nice to have that control back.

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.

Esther: After I gave birth to my two and a half year old daughter, I started noticing some pain in my lower back and upper back. Severe pain that I can barely lift up my hands. Then I started having some sensitivity to heat and cold. My daughter's milk bottle, it would be scorching hot and I could not even feel it. I called my doctor and they said, “It's postpartum issues. Maybe I'm just straining myself from picking up a 10 pound baby,” because she was born at 10 pounds.

So, the pain was so severe on my neck that she prescribed some medicine. And then it started progressing up to the fact that I could barely get up from the bed to walk, and I could barely even stand up straight. I have to ask my husband to hold me or hold onto a wall to move from one place to the other in the house. It was very emotional, very unbearing, and I was hopeless in a way that I felt like I was being a bad mom because I'm not there for them physically and emotionally, because I still have the three year old who needs me and the baby who I was still nursing and I could barely hold her without me feeling that pain.

So, I went home, called my doctor and said, "I need to be seen right away." At that doctor's office I told her, "I'm not leaving until I get something to be done." Within 30 minutes, I was referred to a neurologist. I saw a neurologist the next day and I had MRI of my spinal cord, thoracic cervical spinal cord and MRI of the brain, all in one day. The next day, the neurologist came with a nurse practitioner and said, "We have a name for what we think you have, but we need to do a spinal tap to verify it." Within an hour, the results came back and was told, "You are diagnosed for NMOSD."

Narrator: Esther was diagnosed with neuromyelitis optica spectrum disorder, or NMOSD, a rare, lifelong autoimmune disease caused by inflammation in the central nervous system (CNS), which is made up of the optic nerve, brain stem and spinal cord.

Esther: So that's where I started asking the questions: "What is this? Is it treatable? Is it curable? What are the treatments for it?" The question about UPLIZNA came after my second hospitalization. And when I went to the doctor's office, he told me, "There's several FDA-approved infusion."

Narrator: Esther and her doctor reviewed the possible side effects, efficacy and dosing schedule and decided the best option for her was UPLIZNA.

Esther: So, what really finally got me to the point of picking UPLIZNA was the fact that it's only administered twice a year. It was just an easy decision. After the first infusion, you have another infusion after two weeks, and then it's only every six months. That works perfect for my lifestyle because I would like to focus my attention on my family, doing other things that I love, instead of having to just focus on treatment for NMOSD.

Narrator: Before her first infusion, Esther received a call from her Patient Access Liaison (PAL), to help answer non-medical, logistical questions, like what to expect with UPLIZNA and the insurance process.

Esther: I had a call from a Patient Access Liaison saying that, "I saw your infusion coming up and I would like to introduce myself and I'm here for you. If you have any questions about the medication, if you have any questions about insurance company and payment, just let me know." It's like an instant connection when she called me because being diagnosed, I felt like I was alone and it was a sign of relief for me.

The first infusion day was very much a happy day for me. I got all dressed up and my husband looked at me like, "Where are you going?" I'm like, "I'm going for my infusion." Since my infusion, I've not had any relapse. I still have some pain and I still have some muscle spasms, but it's not as worse as it was before I had my relapse. After my infusion, I feel like I can now focus on the things that I love to do. I can now focus on being a mother and being there for my active little girls and being there as a wife.

I'm sharing my story today because I want people who are struggling for that answer, either for the diagnosis, either for the correct treatment, people who need the right infusion. I want them to know there is always an answer somewhere. And if my story can help someone get access to better care, to get the answer they need, then I know that my story has been told the right way. It's not my NMO, it's my diagnosis, but it's not the main focus of my life.

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.

Jasmine: When I went into health care initially, I was trying to find what would be my passion. Then when I got diagnosed, it made me push even more to help patients and share my experience.

On a Wednesday, in January 2021, I kind of felt like there was something in my left eye. I was thinking it was an eyelash or something. And then by that Thursday, my vision started looking, like, hazy. And I went to the neurologist I work with and I was like, "Something's going on with my vision." They had me see an ophthalmologist the same day, and they were like, "Well, if it is optic neuritis, you'll lose vision and we'll go from there."

He had me do, like, a test for the optic nerve. And then we see that it was very inflamed. And then the doctor sent me to the emergency room. "You are going to get scans of your brain, whole spine and of my optic nerve.” And then they were already signing me up for a spinal tap. They were already signing me up for, like, all these different tests. And with the emergency room, it really wasn't clear answers, it was just like the shuffle and waiting to figure out what's going on.

Narrator: Initially, doctors believed Jasmine may have had multiple sclerosis, or MS.

Jasmine: So, I'm there. They're telling me about MS and the medications. I was going to go sign up for my MS medicine. And then later on that day, a doctor who specializes with neuroimmunology was like, "Don't go. You have something totally different, and we'll meet to talk about it." And I was just like, "What other things could there be?" And she was explaining like, "There's another disease that kind of mimics MS very closely." And it was NMOSD.

Narrator: Doctors diagnosed Jasmine with neuromyelitis optica spectrum disorder, or NMOSD, a rare lifelong autoimmune disease caused by inflammation in the central nervous system (CNS), which is made up of the optic nerve, brain stem and spinal cord.

Jasmine: Then I met with my doctor, my neurologist, and she was explaining there was a medicine that just came out and she thinks that it will be better for me just based off of what I told her. She asked me like, "What do you feel more comfortable with?” She was like, “Do you want to take a pill every day? Do you want to give yourself shots once a month, or do you want something where it's you get it twice a year?" She was very confident in me taking UPLIZNA.

Narrator: Jasmine and her doctor reviewed the possible side effects and decided the best option for her was UPLIZNA. UPLIZNA is the only FDA-approved NMOSD therapy with treatment just two times a year, following two initial doses.

Jasmine: My first infusion was in March 2021, and since I was the first patient at my hospital to get UPLIZNA, it was like a big celebration and everyone was clapping. So that made me feel happy because everyone was kind of like wanted to learn about how to administer UPLIZNA and checking up on me.

After that, I just went to sleep and I woke up and I was like, "Oh, I'm done." After my first infusion, the side effect I had mostly was like a little bit of a headache, but it was mostly fatigue and just weakness. I feel like every time I get an infusion, I'm feeling a little bit more like myself. I'm not feeling weak and tired or just worried that I'll have an attack or worried something's not working. Before I got diagnosed with NMOSD, I was in nursing school. And then when I got diagnosed, I had to stop going to school just to focus on the right now, which was my health. And now that I'm in a better place, I'm back in school doing awesome.

Yes, I have NMO. Yes, some days are better than others, but I'm doing everything that I can and I'm pushing myself and I'm listening to my body and I'm getting the support from my physicians, my family, everyone.

You have to advocate for yourself, especially if you're in places where you don't have access to doctors who specialize in it. I think it's fair, if you go in and see a doctor, you should ask them like, "Are you familiar with NMOSD? Do you have other NMO patients?" Having a doctor that knows about NMO, they can reassure you about your concerns. That's very important.

Having NMO has now helped me have more passion for helping patients, especially with rare diseases, because not many people are going to know. And I want to make sure my patients are getting the right care for them every time, because that was important for me during my journey. It makes you feel like someone cares.

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.

Betsy: I'm angry that this happened to me. I'm angry that I don't have control of my life anymore. I'm angry that I can't walk the way I want to. I'm angry that I can't go on a run. I can't go on a hike. I'm mad, and I think mad can be good because it pushes you.

On December 30th, 2018, I had a blazing sinus infection, and as the day progressed, I just got really, really dizzy to the point where I couldn't even stand up. At one point, I had this huge, huge flash of white light go off in my head and I just fell right over onto the floor and we called an ambulance and they brought me to the emergency department. They did a CT scan and it came back and they didn't like what they saw. And so I ended up going for an MRI and they called in a neurologist. And I had a week long stay with lots of testing. And when I left, I no longer knew how to walk with my left leg. In February of 2019, my neurologist confirmed that NMOSD is what I have. It was a devastating blow.

Narrator: Neuromyelitis optica spectrum disorder, or NMOSD, is a rare, lifelong autoimmune disease caused by inflammation in the central nervous system (CNS), which is made up of the optic nerve, brain stem and spinal cord. With the help of UPLIZNA for treatment, and the support of her care team, Betsy has learned how to manage her journey with NMOSD.

Betsy: The connections you make with your providers and the nurses, you're talking everybody as a whole, they just make the process so much easier at times and they're like, "It's okay. You need to cry? Go ahead. You need to yell? Go ahead." They're all like my safety net, something I could fall back on and be like, "Okay, I'm having something rough, can you guys help me out?" And they're all there. They're all willing. So you talk to them about everything. No matter how bad it is, no matter how good it is, or embarrassing or not embarrassing, because that comfortability factor, it's important to have with your provider because they're the ones who's going to direct you into what it is you should look into and address.

And I'm grateful, very, very grateful. Don't ever stay in that mad place, because then you can't be happy. No matter what, you have to move forward. Yesterday was a rough day for me, but I'm here because I don't want to stay there in that place of anger and that frustration. I think it's important that you live your best life and you sparkle, because I want everybody to sparkle. I think that everybody needs to smile. You're not alone. No matter how rare it is, there are people out there who will help you. There are people who will help guide you. And it's not the end and you don't need to be sad all the time.

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.

Panga: If I were to speak to someone that was diagnosed with NMOSD, I would tell them to be patient, to be hopeful. For me, when I'm going through the loneliness and, feeling like nobody cares, it's devastating. My journey has made me know and understand that there's some help out there for you.

Narrator: Once prescribed UPLIZNA, a Patient Access Liaison, or PAL, can help answer non-medical, logistical questions, like what to expect with UPLIZNA and the insurance process.

Panga: Hey!

Dylesha: How are you?

Panga: I'm good. How are you? My first impression of Dylesha was, she made me feel comfortable. She was a listener. I'm a people person and listening to her, yeah, we hit it off pretty good.

Dylesha: So, whenever an enrollment form comes in from a physician's office, I pick up the phone and I call them and I introduce myself and just let them know that I'm here to help them navigate whatever it is that they need in regards to infusion or insurance issues. Just making sure that they have access to the resources that we have access to regarding not only their NMOSD, but UPLIZNA as well.

Panga: We talked about, some of the areas that she would be able to assist me with. From that point on, I made her aware whenever I had my doctor's appointments and everything and let her know how that goes. And, even when I'm not doing well, I might call her and she actually has been very helpful to me to say, “What you could do and check with your family care doctor and find out.” But, most definitely some of the things that I've called to her attention, she has been there to say, "Go see a doctor and find out what it is. Let me know how it goes." And so, I appreciate her for that.

Dylesha: I think the initial place of need that I felt for her and honestly that I feel for most people, is to be a listener. She's also a person who is very involved in her own health care, which means that she does a lot of research on her own. So, she has been able to teach me some things. I've learned a lot from her, which has enabled me to help other people.

I think for her and I, building this relationship where I want to make sure that she knows that I'm not just here just to make sure you get your infusion. But I'm also here to be a friend, if you need that today. To be a listener, if you need that today. To be a confidant, if you need that today. To be a PAL, if that's what you need today. If I can help her with an insurance issue or help find her some additional resources, if I can make sure that her infusions are set up in a timely manner, if I can do all of those things and she doesn't have to worry about that, I'm good with that.

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.