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Overview: Ultomiris is used to treat certain rare conditions that affect the blood, kidneys, nerves, or muscles. It works by blocking part of the immune system that can mistakenly damage your own blood cells, nerves, or kidneys. Common side effects include cold symptoms, headache, and diarrhea. Ultomiris raises your risk of serious, life-threatening infections such as meningitis, so you may need certain vaccines before you start it. Contact your health care provider right away if you have signs of a serious infection, such as fever, a headache with a stiff neck, or vision that is sensitive to light.

Uses

What is Ultomiris used for?

Ultomiris (ravulizumab-cwvz) is commonly used for the following conditions. 

Learn more about Ultomiris for the Treatment of Generalized Myasthenia Gravis.

Ultomiris may also be used for other conditions as determined by your health care provider.

How does Ultomiris work (mechanism of action)?

Ultomiris is a type of medicine called a monoclonal antibody. It works by blocking part of your immune system called the complement system. Normally, the complement system is a group of proteins that helps your body fight infections. In people with certain conditions, these proteins become overactive or are turned on by mistake, and they damage your own body.

Ultomiris attaches to one of these complement proteins, called C5, and stops it from working. This helps prevent damage to your cells and organs.

How is Ultomiris supplied (dosage forms)?

Ultomiris is available as an injection that is given by a health care professional.

How should I store Ultomiris?

Ultomiris is usually given by a health care provider in a hospital or clinic. You will not store it at home. 

Side Effects

What are the most common side effects of Ultomiris?

The most common side effects of Ultomiris are listed below. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of Ultomiris that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Ultomiris?

While less common, the most serious side effects of Ultomiris are described below, along with what to do if they happen.

Severe Allergic Reactions. Ultomiris may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infection. Ultomiris may increase your risk of infections, including meningitis and blood infection (septicemia). These conditions are serious and can even be life threatening. Call your health care provider right away if you have any of the following.

  • Fever or cold symptoms
  • Rash
  • Headache
  • Nausea and vomiting
  • Stiffness in your back or neck
  • Confusion
  • Muscle soreness
  • Eyes become sensitive to light

Warnings & Precautions

Who should not use Ultomiris?

Allergies to Ingredients. People who are allergic to any of the following should not take Ultomiris.

  • Ultomiris
  • Ravulizumab-cwvz
  • Any of the ingredients in the specific product dispensed

Your health care provider can tell you all of the ingredients in Ultomiris. 

Infection. People who have an unresolved serious infection with a bacteria called Neisseria meningitidis should not use Ultomiris. 

What should I know about Ultomiris before using it?

If you have not received your full meningitis vaccine shots, your health care provider will recommend you get your meningitis vaccines which protects you against meningitis serogroups (types) A, C, W, Y and B. You may need to take antibiotics if you need to start Ultomiris right away but have not finished your meningococcal vaccine series. Even if you have completed your vaccine series, you can still get a serious infection. 

Ultomiris may lower your ability to fight certain types of infections including those which cause infections of the ears, throat, lungs, and nose. 

During treatment and 8 months after your last dose, people who use Ultomiris should carry the patient safety card which provides information about the serious side effects of Ultomiris.

What should I tell my health care provider before using Ultomiris?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Ultomiris is right for you.

In particular, make sure that you discuss any of the following.

  • If you get infections easily or currently have one
  • Use plasma exchange or plasmapheresis (removal and separation of plasma from blood)

Pregnancy. It is not known if or how Ultomiris could affect pregnancy or harm a fetus. Tell your health care provider if you are or plan to become pregnant. Your health care provider will let you know if you should use Ultomiris while you are pregnant or trying to get pregnant. If you become pregnant while using Ultomiris, you can register for the Ultomiris Pregnancy Study by calling 833-793-0563 or at www.ultomirispregnancystudy.com. This registry collects safety information about the use of Ultomiris during pregnancy.

Breastfeeding. It is not known if Ultomiris passes into breast milk. Do not breastfeed while using Ultomiris and for 8 months after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Ultomiris?

For more information about Ultomiris, you can visit the drugmaker's website at www.ultomiris.com or call them at 888-765-4747.

Interactions

Does Ultomiris interact with foods or drinks?

There are no known interactions between Ultomiris and foods or drinks.

Does Ultomiris interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. 

In particular, make sure that you discuss if you are using any of the following before using Ultomiris.

  • Intravenous Immunoglobulin 
  • A neonatal Fc receptor (FcRn) blocker, such as efgartigimod (Vyvgart), a type of medicine used to treat myasthenia gravis 

This may not be a complete list of medicines that can interact with Ultomiris. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Ultomiris?

If you or someone else has used too much Ultomiris, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Ultomiris?

Ultomiris is usually given by a health care provider in a hospital or clinic. Your health care provider will make sure you are receiving Ultomiris as scheduled.

If you miss an appointment to get your Ultomiris infusion, call to make another appointment as soon as possible.