Uses
What is Ultomiris used for?
Ultomiris (ravulizumab-cwvz) is commonly used for certain rare and serious blood and nerve problems. Specifically, Ultomiris is used for conditions where the immune system mistakenly attacks your own red blood cells or nerve cells which carry sensory information to and from your brain. The conditions Ultomiris is used to treat include the following.
- Paroxysmal nocturnal hemoglobinuria (PNH), a condition caused by the immune system killing red blood cells
- Atypical hemolytic uremic syndrome (aHUS), a condition caused by the immune system killing red blood cells and is often associated with a genetic problem
- A condition called generalized myasthenia gravis (gMG) with the antibody called anti-acetylcholine receptor (AChR) which affects muscle and nerve coordination
- A condition which affects the nervous system and vision called neuromyelitis optica spectrum disorder (NMOSD) with an antibody called anti-aquaporin-4 (AQP4)
Learn more about Ultomiris for the Treatment of Generalized Myasthenia Gravis.
Ultomiris may also be used for other conditions as determined by your healthcare provider.
How does Ultomiris work (mechanism of action)?
Ultomiris is an antibody which prevents a part of your immune system (natural defense) from attacking and killing your own nerve cells or blood cells. Ultomiris works by attaching to certain proteins called complement proteins. Sometimes, these proteins can mistakenly target your own cells to attack, especially when you have genetic changes (mutations) or other conditions.
How is Ultomiris supplied (dosage forms)?
Ultomiris is available as an injection that is given by a healthcare professional.
How should I store Ultomiris?
Ultomiris is usually given by a healthcare 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 healthcare provider if you have any of these side effects that bother you.
- Infection in the nose or throat, sore throat, or common cold symptoms
- Diarrhea
- Nausea and vomiting
- Headache
- High blood pressure
- Fever
- Back or joint pain
- Kidney or bladder infection
There may be other side effects of Ultomiris that are not listed here. Contact your healthcare 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. 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. Stop using Ultomiris and 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, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
- Chest 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 healthcare 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
- Revulizumab-cwvz
- Any of the ingredients in the specific product dispensed
Your healthcare provider can tell you all of the ingredients in Ultomiris.
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 healthcare 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, 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 healthcare provider before using Ultomiris?
Tell your healthcare 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 determine 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 an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you 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. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop Ultomiris.
How can I get more information about Ultomiris?
For more information about Ultomiris, you can visit the manufacturer’s website at https://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 healthcare 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
- Egartigimod, a medicine in a class called neonatal Fc receptor blocker used to treat myasthenia gravis
This may not be a complete list of medicines that can interact with Ultomiris. Always check with your healthcare provider.
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 healthcare provider in a hospital or clinic. Your healthcare provider will make sure you are receiving Ultomiris as scheduled.
If you miss an appointment to get your Ultomiris dose, call to make another appointment as soon as possible.