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.