Frequently asked questions

The most common symptoms of NMOSD can include blurry vision, blindness in one or both eyes, sleeping problems, painful spasms, weakness or paralysis in legs or arms, numbness or loss of sensation throughout the body, persistent hiccups, persistent nausea or uncontrollable vomiting, and bladder or bowel dysfunction.

Most people with NMOSD test positive for anti-aquaporin-4 (AQP4) antibodies. If you think that you might have NMOSD, you can use the tool below to help start a conversation with your doctor at your next visit.

ULTOMIRIS is a prescription medicine called a monoclonal antibody. ULTOMIRIS is used to treat adults with a disease called 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.

ULTOMIRIS is given through a vein by intravenous (IV) infusion.

If you are an adult with NMOSD, you will usually receive:

• a starting dose of ULTOMIRIS as an infusion by your doctor, and then
• 2 weeks later, you will start to receive an infusion of ULTOMIRIS once every 8 weeks

ULTOMIRIS is a medicine that affects your immune system. ULTOMIRIS may lower the ability of your immune system to fight infections.

• ULTOMIRIS increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria. Meningococcal infections may quickly become life-threatening or cause death if not recognized and treated early.
• You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of ULTOMIRIS.
• 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.
• If you have not been vaccinated and ULTOMIRIS must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you.
• 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.
• 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 serious meningococcal infection:
• fever
• fever with high heart rate
• headache and fever
• confusion
• muscles aches with flu-like symptoms
• fever and a rash
• headache with nausea or vomiting
• headache with stiff neck or stiff back
• 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 dose of ULTOMIRIS. 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 ULTOMIRIS and SOLIRIS 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 you are not up to date on your vaccines
• give you a Patient Safety Card about your risk of meningococcal infection, as discussed above

ULTOMIRIS may also increase the risk of other types of serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.

• Certain people may be at risk of serious infections with gonorrhea. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing

Call your healthcare provider right away if you have any new signs or symptoms of infection.

Do not receive ULTOMIRIS if you have a serious meningococcal infection at the time you would be starting ULTOMIRIS treatment.

Before you receive ULTOMIRIS, tell your doctor 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
• 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 doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ULTOMIRIS and other medicines can affect each other. Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

ULTOMIRIS can cause serious side effects including:

• Infusion-related reactions. Infusion-related reactions may happen during your ULTOMIRIS infusion. Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, abdominal pain, muscle spasms, changes in blood pressure, tiredness, feeling faint, shaking chills (rigors), discomfort in your arms or legs, bad taste, or drowsiness. 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
• feel faint or pass out

Your doctor will evaluate your symptoms as needed.

The most common side effects (≥10%) of ULTOMIRIS during the clinical trial for NMOSD were:

• headache
• COVID-19 infection
• back pain
• joint pain
• urinary tract infection

Tell your doctor 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 doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• You can download the Patient Brochure and Medication Guide
• You can also connect with your local Alexion Patient Education Manager through Alexion OneSource™
• Please check back in with OneSource frequently as new information becomes available
• Your healthcare team is the best resource for decisions about your treatment

• The exact amount you will pay depends on your insurance provider and coverage plan
• OneSource can help you determine your out-of-pocket costs and may offer health insurance navigation
• Contact OneSource at 1-888-765-4747

• ULTOMIRIS was FDA approved for adults with NMOSD who are anti-AQP4 antibody positive on March 22, 2024
• The FDA approved ULTOMIRIS for its first indication in December 2018

The best first step is to talk to your doctor and ask about starting ULTOMIRIS.

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.

You must complete your or update meningococcal vaccine requirements at least 2 weeks before starting treatment with ULTOMIRIS. If you have not been vaccinated for meningococcal infections and ULTOMIRIS therapy must be initiated immediately, you should also receive antibiotics to take for as long as your healthcare provider tells you. Talk to your doctor if you are unsure if you are up to date with your meningococcal vaccinations.

NMOSD is a chronic disease, and there is no known cure. Speak with your physician about your need for ongoing therapy.

Talk to your doctor about making the transition to ULTOMIRIS. Transitioning from another treatment to ULTOMIRIS should be done at the discretion of your doctor, who will use their clinical judgment in deciding the appropriate course of action.

In the clinical trial, people taking ULTOMIRIS could continue certain immunosuppressant therapies. Talk to your doctor about any medication you are currently taking and whether they may need to adjust your dose.

There are no medications to take before being prescribed ULTOMIRIS and receiving your first infusion. However, ULTOMIRIS can lower your body's ability to fight meningococcal infections, so people taking ULTOMIRIS must receive the meningococcal vaccines at least 2 weeks prior to their first infusion. If you have not been vaccinated for meningococcal infections and ULTOMIRIS therapy must be initiated immediately, you should also receive antibiotics to take for as long as your healthcare provider tells you.

While the exact mechanism of ULTOMIRIS in NMOSD is unknown, ULTOMIRIS is a complement inhibitor that specifically binds to the complement protein C5. In the clinical trial for ULTOMIRIS in NMOSD, the majority (98.3%) of people had complete C5 inhibition by the end of the first infusion.

If you have NMOSD that is anti-AQP4 antibody positive, talk to your doctor about whether ULTOMIRIS could be right for you. People taking ULTOMIRIS had ZERO relapses during the clinical trial. ULTOMIRIS reduced the risk of relapse by 98.6% compared to placebo.

If you are making the transition from SOLIRIS to ULTOMIRIS, you should receive your starting dose of ULTOMIRIS at the time of your next scheduled dose of SOLIRIS.

ULTOMIRIS is built on the foundation of SOLIRIS. Both treatments bind to and block complement protein C5, but ULTOMIRIS is designed to last longer so that you only need a maintenance dose once every 8 weeks.

While there are no clinical trials to compare ULTOMIRIS and SOLIRIS, frequency of administration is a key difference between them. After an initial loading dose, SOLIRIS is administered every 2 weeks, while ULTOMIRIS is administered every 8 weeks. Please follow up with your doctor for more information.