Getting Started
With UPLIZNA

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 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. 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, 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. 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 called 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—the 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. I was able to make a decision based on the pros and cons of each one and which one would work best for me.

Narrator: Together, Michelle and her doctor decided on UPLIZNA, also known as inebilizumab-cdon.

UPLIZNA is the only FDA-approved AQP4 antibody positive NMOSD therapy in adults with treatment just two times a year, following two initial doses.

You should not receive UPLIZNA if you have had a life-threatening infusion reaction to UPLIZNA or if you have an active hepatitis B virus infection, or active or untreated inactive (latent) tuberculosis. Please see additional Important Safety Information later in this video and the medication guide available on UPLIZNA.com.

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 come home, I take my kids to scouting events, to church events.

So, my advice to someone who’s recently been diagnosed with NMOSD is first, it’s okay to be sad. It’s okay to cry. But then you need to talk to your doctor and see all of the options that are out there available for you.

IMPORTANT SAFETY INFORMATION

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.

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.

Please see UPLIZNA full Prescribing Information, including Medication Guide.