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Understanding NMOSD

NMOSD is a rare chronic autoimmune disease that impacts the central nervous system

NMOSD relapses can cause irreversible damage to the body

When you have an autoimmune disease like neuromyelitis optica spectrum disorder (NMOSD), your body attacks its own healthy cells. In anti-aquaporin-4 (AQP4) antibody-positive NMOSD, part of your immune system called "complement" damages your central nervous system, which consists of your brain, spinal cord, and optic nerve (eyes).

NMOSD is characterized by unpredictable relapses that can result in various disabilities.

While the root cause of NMOSD is unknown, most people with the disease test positive for anti-AQP4 antibodies.

While not everyone will experience the same or all symptoms, common NMOSD symptoms can include:

Blurry vision or blindness in one or both eyes

Weakness or paralysis in legs or arms

Painful spasms

Persistent hiccups

Sleeping problems

Persistent nausea/ uncontrollable vomiting

Numbness or loss of sensation throughout the body

Bladder or bowel dysfunction

Sexual dysfunction

Brain fog

Anxiety

Depression

If not managed properly, NMOSD relapses can come on suddenly and may result in permanent disability.

NMOSD disproportionately affects women and people of African and Asian descent

Women are about 5 times more likely to develop NMOSD than men

People of African and Asian ancestry have a higher prevalence rate of NMOSD

Alexion is committed to bringing awareness to and eliminating the diagnostic and care disparities faced by people of affected ancestries with NMOSD.

NMOSD relapses can have long-term effects

3 out of 4 people never fully recover from their first NMOSD attack.

Within 5 years of their first attack,

22% of patients are expected to require a cane to walk

Based on the results of 1 study, more than 40% are expected to become blind in at least 1 eye*

*In a study of 163 people who have anti-AQP4 antibody-positive NMOSD (2005-2011).

For more information or for support in understanding how NMOSD may affect you or those around you, reach out to a local Patient Education Manager

 

The goal of NMOSD treatment is to reduce the risk of relapse

ULTOMIRIS® Results

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.

  • ULTOMIRIS increases your chance of getting serious meningococcal infections that may quickly become life-threatening or cause death if not recognized and treated early.
  1. You must complete or update meningococcal vaccine(s) at least 2 weeks before your first dose of ULTOMIRIS.
  2. If you have not completed your meningococcal vaccines and ULTOMIRIS must be started right away, you should receive the required vaccine(s) as soon as possible.
  3. If you have not been vaccinated and ULTOMIRIS must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccines before starting ULTOMIRIS. Your healthcare provider will decide if you need additional meningococcal vaccines.
  5. Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and a rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, or eyes sensitive to light.

Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. Your risk of meningococcal infection may continue for several months after your last dose of ULTOMIRIS. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

ULTOMIRIS is only available through a program called the ULTOMIRIS and SOLIRIS Risk Evaluation and Mitigation Strategy (REMS). Before you can receive ULTOMIRIS, your healthcare provider must: enroll in the REMS program; counsel you about the risk of serious meningococcal infections; give you information about the signs and symptoms of serious meningococcal infection; make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start ULTOMIRIS right away and are not up to date on your vaccines; give you a Patient Safety Card about your risk of meningococcal infection.

ULTOMIRIS may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae. Certain people may be at risk of serious infections with gonorrhea.

Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you have a serious meningococcal infection when you are starting ULTOMIRIS.

Before you receive ULTOMIRIS, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection or fever
  • are pregnant or plan to become pregnant. It is not known if ULTOMIRIS will harm your unborn baby.
    • Pregnancy Registry: There is a registry for pregnant women who take ULTOMIRIS to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking ULTOMIRIS, talk to your healthcare provider about how you can join this registry or you may contact the registry at 1-833-793-0563 or www.UltomirisPregnancyStudy.com to enroll.
  • are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment.

What are the possible side effects of ULTOMIRIS?
ULTOMIRIS can cause serious side effects including infusion-related reactions. Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, stomach (abdominal) pain, muscle spasms, changes in blood pressure, tiredness, feeling faint, shaking chills (rigors), discomfort in your arms or legs, or bad taste. Stop treatment of ULTOMIRIS and tell your healthcare provider right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion-related reaction, including: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out.

The most common side effects of ULTOMIRIS in people with NMOSD are COVID-19 infection, headache, back pain, urinary tract infection, and joint pain (arthralgia).

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of ULTOMIRIS. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INDICATION
What is ULTOMIRIS?
ULTOMIRIS is a prescription medicine used to treat adults with a disease called Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody positive. It is not known if ULTOMIRIS is safe and effective for the treatment of NMOSD in children.

Please see full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious meningococcal infections.