Chapter 1: What is NMOSD?

Neuromyelitis optica spectrum disorder, or NMOSD, is 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. Without treatment, continued inflammation can lead to severe attacks that can result in permanent disability.

In a healthy, functioning immune system, B cells create antibodies that help protect you from viruses and bacteria that cause illnesses like the common cold or stomach flu. But when you have NMOSD, those same B cells mistakenly create antibodies that target your central nervous system instead.

This causes inflammation in the central nervous system that leads to NMOSD attacks.

These attacks can cause life-changing symptoms and disability, including but not limited to vision problems that may lead to blindness, difficulty walking that may lead to paralysis, loss of bladder and bowel control, and pain throughout body.

Following your NMOSD diagnosis, you may be feeling anxious about your next attack and what it means for your future. At the same time, you may also feel reassured to finally know that the symptoms you’ve been experiencing have a name, NMOSD, and it can be effectively treated.

Chapter 2: 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.

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.

UPLIZNA is the only FDA-approved medicine for adults with anti-AQP4 antibody positive NMOSD that targets B cells at nearly all stages of their life cycle, both early and as they mature.

While the exact way UPLIZNA works in NMOSD is unknown, it is believed to target B cells.

In a study, UPLIZNA was proven to reduce the risk of attacks that may lead to permanent disability and also reduces the risk of NMOSD-related hospitalizations.

UPLIZNA demonstrated a 77% relative reduction in the risk of attacks compared to placebo. Nearly 9 out of 10 patients were attack free at 28 weeks compared to approximately 6 out of 10 of those receiving placebo.

Chapter 3: What Can I Expect?

UPLIZNA is an intravenous, or IV, medicine. That means UPLIZNA is given through a needle placed into a vein in your arm. This takes place at an infusion center or doctor’s office. Each infusion of UPLIZNA will last about 90 minutes.

Your initial infusions will take place 2 weeks apart in the first month. After these initial treatments, you will only need 1 dose of UPLIZNA every 6 months, starting 6 months from the first infusion.

UPLIZNA is the only FDA-approved NMOSD treatment for adults with anti-AQP4 antibody positive NMOSD that offers twice-yearly dosing after your initial treatments.

Before your infusion appointment, your doctor will test you for infections such as hepatitis B and tuberculosis. You should inform your doctor if you had or are scheduled to receive a vaccination, which you may receive at any point up to 1 month before your first infusion.

During your appointment, your doctor will give you medicine before your UPLIZNA infusion to reduce any infusion reactions. These will be a corticosteroid through an IV, an antihistamine, like Benadryl, and an antifever medicine, like Tylenol.

You will be monitored at the infusion center or doctor’s office, for at least 1 hour after each infusion, to make sure you aren’t experiencing any infusion reactions.

To pass the time, it may help to bring a book, or download a movie or podcast to enjoy while at the infusion center.

Chapter 4: Has the safety of UPLIZNA been studied in clinical trials?

UPLIZNA was shown to have an established safety profile in the largest NMOSD patient study ever conducted.

The study was designed to reflect the real-world NMOSD patient population and included more than 200 patients from 25 countries.

In a clinical trial, the most common side effects included urinary tract infections, in 11% of people, joint pain, in 10% of people, headaches, in 8 percent of people and back pain, in 7 percent of people.

In this trial, some people experienced infusion reactions. Infusion reactions are a type of side effect that occurred in about 1 in 10 people. They included headache, rash, nausea, fever, sleepiness, shortness of breath, muscle aches and palpitations.

These are not all the possible side effects of UPLIZNA. Please listen to the full Important Safety Information at the end of this video.

Chapter 5: What support is available for this next step in the journey?

Amgen By Your Side is a patient support program designed specifically for patients prescribed UPLIZNA.

Your Patient Access Liaison, or PAL, is a dedicated support partner who helps investigate, explain, and educate on each step of your treatment experience. They will work directly with you to answer nonmedical questions and provide resources you may need.

Your PAL can help you avoid surprises at the start of treatment by talking about what to expect. If you need to find a local infusion center, they can help provide you with options.

Your PAL can also help you to learn about the insurance process and to understand financial assistance options.

The Amgen By Your Side team is here to support you when you need it. To sign up and get started, ask your doctor for a Patient Enrollment Form.

Chapter 6: Please listen to the following Important Safety Information.

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.