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Vaccination Requirements

Help protect yourself with a meningococcal vaccination

 

What to know before starting ULTOMIRIS®

Because of how ULTOMIRIS works in your body, it can reduce your immune system's ability to fight serious infections, like meningococcal infections. While ULTOMIRIS doesn't cause meningococcal infections, it increases your chance of getting one if you're exposed to the bacteria. That's why getting vaccinated before starting ULTOMIRIS is important.

1.

Make sure your meningococcal vaccinations are up to date

Proactively protect yourself by working with your doctor to get vaccinated.

  • You must receive 2 types of vaccination against meningococcal infection, which may quickly become life-threatening or cause death if not recognized and treated early
  • Complete or update your vaccinations against meningococcal infections at least 2 weeks before your first dose
    • If your doctor decides that you need urgent treatment, you should receive meningococcal vaccines as soon as possible
    • If you have not been vaccinated and treatment must be started immediately, you should also take antibiotics for as long as your doctor tells you

If you had a meningococcal vaccine in the past, talk to your doctor about whether you may need an additional vaccine before starting ULTOMIRIS.

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 and a rash
  • headache with nausea or vomiting
    •
  • fever with high heart rate
  • headache and a fever
  • headache with a stiff neck or stiff back
    •
  • confusion
  • muscle aches with flu-like symptoms
  • eyes sensitive to light
    •

 

Find more information about getting vaccinated for meningococcal infections before starting ULTOMIRIS.

OneSource™ Vaccination Support

  • Helps you find a place to get vaccinated
  • Assists with navigating your insurance plan or other resources for covering the vaccination costs
  • Gives you useful tools and information about meningococcal vaccinations

Download the Meningococcal Vaccination Guide to get more information about getting vaccinated for meningococcal infection before starting ULTOMIRIS.

Call today to connect with your OneSource Support Specialist:

1-888-765-4747, Monday-Friday, 8:30 AM-8 PM ET

2.

Your doctor will enroll you in a program called Risk Evaluation and Mitigation Strategy (REMS)

ULTOMIRIS is only available through the REMS program. The goal of the REMS is to reduce the risk of serious meningococcal infections. This program:

  • Counsels you about the risk of serious meningococcal infections
  • Gives you information about the signs and symptoms of serious meningococcal infections
  • Makes 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
3.

A Patient Safety Card will be provided by your doctor

  • 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

 

Talk to your doctor about ULTOMIRIS

Start the Conversation

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.