Skip to main content

Getting Started

ULTOMIRIS® offers predictable maintenance dosing once every 8 weeks

ULTOMIRIS (ravulizumab-cwvz) is delivered through a vein by intravenous infusion just 6-7 times per year after your initial dose. While travel and wait times may vary, infusions take less than 1 hour for most people*

An infusion bag that specifies treatment is required only once every 8 weeks for about 1 hour per infusion

ULTOMIRIS dosing schedule

The recommended dosing regimen starts with an initial dose. Two weeks afterward, you can begin maintenance dosing every 8 weeks.

  • After your infusion, your care team will monitor you for at least an additional hour for infusion-related reactions

*Minimum infusion times for ULTOMIRIS 100 mg/mL maintenance doses range from 30 minutes to less than 1 hour, depending on body weight.

If you have not already had them, you must receive the meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS

ULTOMIRIS can lower the ability of your immune system to fight some infections. Before taking ULTOMIRIS, you must be vaccinated against meningococcal infection, a severe and life-threatening infection that can occur in the blood and that requires immediate medical attention. Your doctor or nurse will make sure you receive these vaccines at least 2 weeks before your first infusion.

If your doctor decides that urgent treatment with ULTOMIRIS is needed, you should get the meningococcal vaccines as soon as possible. If you have not been vaccinated and ULTOMIRIS must be started immediately, you should also receive 2 weeks of antibiotics with your vaccinations.

If you had a meningococcal vaccine in the past, you might need a booster dose before starting ULTOMIRIS. Your doctor will decide if you need a booster dose for meningococcal infections.

Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:

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

Carry your Patient Safety Card

ULTOMIRIS patient safety card

Your doctor will give you a Patient Safety Card about the risk of 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 doctor or nurse who treats you. This will help them diagnose and treat you quickly.

ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS)

Before you can receive ULTOMIRIS, your doctor must:

  • enroll in the ULTOMIRIS REMS program
  • counsel you about the risk of meningococcal infection
  • give you information about the symptoms of meningococcal infection

With only 6-7 maintenance infusions per year, ULTOMIRIS dosing leaves you with more time to do what you love

JOIN OUR WEBINARS

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 can lower the ability of your immune system to fight infections.

  • ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early.
  1. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you are not vaccinated.
  2. If your healthcare provider decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible.
  3. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccination. Your healthcare provider will decide if you need additional vaccination.
  5. Meningococcal vaccines reduce but 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: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms and eyes sensitive to light.

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

ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your healthcare provider must: enroll in the ULTOMIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. Ask your healthcare provider if you are not sure if you need to be revaccinated.

ULTOMIRIS may also increase the risk of other types of serious infections. Call your healthcare provider right away if you have any new signs or symptoms of infection.

Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you have a meningococcal infection or have not been vaccinated against meningococcal infection unless your healthcare provider decides that urgent treatment with ULTOMIRIS is needed.

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, and are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS will harm your unborn baby or if it 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, tiredness, feeling faint, discomfort in your arms or legs, bad taste, or drowsiness. Stop treatment of ULTOMIRIS and tell your healthcare provider or nurse right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion 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 gMG are diarrhea and upper respiratory tract infections.

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 generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

It is not known if ULTOMIRIS is safe and effective for the treatment of gMG in children.

Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis.