If you have a certain rare blood disorder or kind of myasthenia gravis, your doctor might suggest Ultomiris as a treatment option for you.

Ultomiris is a prescription medication that’s used to treat the following conditions:

The active ingredient in Ultomiris is ravulizumab-cwvz. An active ingredient is what makes a drug work. Ultomiris is a biologic drug, which means it’s made from parts of living organisms.

Ultomiris comes as a solution that a healthcare professional gives as an intravenous (IV) infusion (an injection into a vein over a period of time).

If Ultomiris is working for you, you’ll likely use it long term.

For more information about Ultomiris, including details about its uses, see this in-depth article.

Like other drugs, Ultomiris can cause mild to serious side effects. Keep reading to learn more.

Below are some of the more common side effects reported by people who took Ultomiris in studies. These side effects can vary depending on what condition the drug is being used to treat.

More common side effects in people receiving Ultomiris for atypical hemolytic uremic syndrome include:

* To learn more about this side effect, see the “Side effects explained” section below.

More common side effects in people receiving Ultomiris for paroxysmal nocturnal hemoglobinuria include:

  • headache
  • upper respiratory tract infection

More common side effects in people receiving Ultomiris for generalized myasthenia gravis include:

  • upper respiratory tract infection
  • diarrhea

Most side effects of Ultomiris are mild. Examples of mild side effects that have been reported with Ultomiris include the following. These side effects varied depending on the condition Ultomiris was used to treat.

* To learn more about this side effect, see the “Side effects explained” section below.

In most cases, these side effects should be temporary. And some may be easily managed, too. But if you have any symptoms that are ongoing or bother you, talk with your doctor or pharmacist. And don’t stop using Ultomiris unless your doctor recommends it.

Ultomiris may cause mild side effects other than the ones listed above. See the Ultomiris prescribing information for details.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Ultomiris, visit MedWatch.

Some people have experienced serious side effects while receiving Ultomiris in studies, though this was rare.

Serious side effects that have been reported with Ultomiris include:

* Ultomiris has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effects explained” section below.
† To learn more about this side effect, see the “Side effects explained” section below.

If you develop serious side effects while receiving Ultomiris, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Get answers to some frequently asked questions about the side effects of Ultomiris.

Can Ultomiris cause mood changes, such as anger?

In general, it’s not likely. For example, anger was not reported in studies of Ultomiris.

But anxiety was reported by some people receiving Ultomiris to treat atypical hemolytic uremic syndrome (aHUS).

If you’re experiencing mood changes during Ultomiris treatment, talk with your doctor.

Does Ultomiris cause brain-related side effects?

Yes, Ultomiris may cause certain brain-related side effects. In studies of the drug, some people experienced dizziness and headaches.

Others developed meningococcal infection, a more serious and sometimes life threatening side effect involving the brain or spinal cord. In fact, Ultomiris has a boxed warning for risk of this side effect. (For more information, see the “Side effects explained” section below.)

If you have questions about brain-related side effects that Ultomiris might cause, talk with your doctor.

Will I have side effects after suddenly stopping Ultomiris treatment?

It’s possible. If you have paroxysmal nocturnal hemoglobinuria (PNH), your doctor will monitor you for hemolysis (ruptured red blood cells) for 16 weeks after you stop receiving Ultomiris. If you have aHUS, they’ll monitor you for signs and symptoms of thrombotic microangiopathies, such as destruction of red blood cells, low platelet level, and organ damage, for 12 months.

You could also develop a meningococcal infection up to several months after stopping Ultomiris treatment.

Stopping Ultomiris suddenly should not cause withdrawal symptoms. But before you stop receiving Ultomiris, talk with your doctor. They can advise you on how to do so safely.

What Ultomiris side effects might a baby have?

Ultomiris is approved to treat children 1 month and older who have PNH or aHUS.

In studies of Ultomiris, children and adults experienced similar side effects. The most common side effects that occurred in children were upper respiratory tract infections, low levels of red blood cells, belly pain, and headache.

Children also have a risk of meningococcal infections when receiving Ultomiris. Babies may experience different symptoms for this condition than older children and adults, including:

If your baby has any of these symptoms during Ultomiris treatment, contact their doctor right away.

For more information about side effects babies and children of different ages may have from Ultomiris, talk with their doctor.

Learn more about some of the side effects Ultomiris may cause.

Risk of serious meningococcal infections

Ultomiris has a boxed warning for risk of serious meningococcal infections.

Meningococcal infections, which are caused by a certain kind of bacteria, can be severe. In fact, life-threatening infections of this kind occurred in studies of Ultomiris.

Meningococcal infections usually occur in the lining of the brain and spinal cord. They can also spread throughout the body and cause sepsis, a severe response to an infection that can become fatal.

Some of the symptoms of meningococcal infections or sepsis include:

What might help

If your meningococcal vaccinations are not up to date, your doctor will recommend that you get these immunizations at least 2 weeks before starting Ultomiris treatment. Doctors usually won’t prescribe Ultomiris to people who haven’t received meningococcal vaccines. Vaccination reduces your risk of getting a meningococcal infection, though it’s still possible.

Due to the risk of meningococcal infection, Ultomiris is only available through a Risk Evaluation and Mitigation Strategy (REMS) program. The REMS is designed to help prevent anyone who uses Ultomiris from getting this kind of infection. As part of this program, only healthcare professionals who are specially certified may prescribe Ultomiris.

For more information about the Ultomiris REMS, talk with your doctor or visit the Ultomiris REMS program webpage.

If you’re experiencing symptoms of meningococcal infection or sepsis, contact your doctor right away. If any of the symptoms seem life threatening, call 911 or seek emergency medical care immediately.

High blood pressure

In studies, high blood pressure was a common serious side effect in people using Ultomiris to treat atypical hemolytic uremic syndrome.

High blood pressure rarely causes symptoms. But in extreme cases of severe high blood pressure, you may notice symptoms such as:

There weren’t reports of severe high blood pressure that caused symptoms in studies of Ultomiris.

What might help

If you have any concerns about high blood pressure during Ultomiris treatment, talk with your doctor. They may monitor your blood pressure more often during treatment and have you do the same at home. Your doctor may also prescribe medications to help lower your blood pressure.

If you notice symptoms of severe high blood pressure as described above, immediately seek medical attention at the closest emergency room or dial 911.

Anxiety

Anxiety was reported in people using Ultomiris to treat atypical hemolytic uremic syndrome in studies. But it’s unknown whether this side effect was caused by Ultomiris.

Symptoms of anxiety may include:

What might help

To help ease anxiety during Ultomiris treatment, there are a few things you can try at home: taking a warm bath, meditating, listening to calming music, or doing anything that makes you feel calm and safe.

If your anxiety doesn’t lessen or becomes bothersome, talk with your doctor. They can recommend therapy or other medications to help manage this side effect.

Serious infections

In studies of Ultomiris, some people developed serious infections, such as pneumonia or tonsillitis. Children may have an increased risk of developing certain infections while receiving Ultomiris.

Symptoms of an infection may include:

What might help

Make sure you or your child are up to date on vaccinations. Before starting treatment with Ultomiris, ask your doctor about any vaccinations that you may need.

If you develop any symptoms of an infection, contact your doctor right away. They’ll likely want to see you in person to determine the type and severity of your infection. Then they can recommend an appropriate treatment based on your infection.

Allergic reaction

Like most drugs, Ultomiris can cause an allergic reaction in some people. But these reactions were rare in studies of the drug.

Allergic reactions to Ultomiris can be caused by the drug infusion itself. The studies included reports of people who developed anaphylaxis as an infusion-related reaction.

Symptoms can be mild to serious and can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin, usually in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

  • an over-the-counter antihistamine you take by mouth, such as Benadryl (diphenhydramine)
  • a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Ultomiris, they’ll decide if you should continue using it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Ultomiris, they may have you switch to a different treatment.

Keeping track of side effects

During your Ultomiris treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were taking when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how it affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Keeping notes and sharing them with your doctor will help them learn more about how Ultomiris affects you. They can then use this information to adjust your treatment plan if needed.

Ultomiris comes with several warnings, as discussed below.

Boxed warning: Risk of serious meningococcal infections

Ultomiris has a boxed warning for the risk of serious meningococcal infections, which may lead to sepsis. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). Due to this risk, Ultomiris is only available through a safety program called the Ultomiris Risk Evaluation and Mitigation Strategy (REMS).

In studies, some people experienced life threatening meningococcal infections or sepsis while receiving Ultomiris. As a result, doctors usually won’t prescribe Ultomiris to people who have a meningococcal infection or who are not up to date with their meningococcal vaccinations.

To learn more about this boxed warning, see the “Side effects explained” section above.

Other warnings

Ultomiris may not be right for you if you have certain medical conditions. These are known as drug-condition interactions. Other factors may also affect whether Ultomiris is a good treatment option for you.

Talk with your doctor about your health history before starting Ultomiris. The list below includes factors to consider.

  • Active infection. Ultomiris may raise your risk of infection, including serious infections. If you have an existing infection, the drug could make it harder to treat. Prior to treatment with Ultomiris, let your doctor know if you have an active infection. They’ll likely treat it before you start receiving Ultomiris.
  • Allergic reaction. If you’ve had an allergic reaction to Ultomiris or any of its ingredients, your doctor will likely not prescribe Ultomiris. Ask them what other medications are better options for you.

Alcohol and Ultomiris

It’s not known if Ultomiris interacts with alcohol. If you drink alcohol, talk with your doctor about how much, if any, is safe to consume during Ultomiris treatment.

Pregnancy and breastfeeding while receiving Ultomiris

It’s unknown if Ultomiris is safe to use when pregnant or breastfeeding. But untreated atypical hemolytic uremic syndrome or paroxysmal nocturnal hemoglobinuria during pregnancy also has risks, including pregnancy loss and premature delivery.

If you’re pregnant or breastfeeding, or planning to become pregnant or breastfeed, talk with your doctor about the risks and benefits of receiving Ultomiris during this time.

Like many drugs, Ultomiris can cause side effects, but some are more common than others. Most side effects are mild and will resolve on their own or with treatment. Others are more severe and may require immediate medical attention.

Before you start Ultomiris treatment, talk with your doctor about the drug’s side effects. This information can help you decide whether Ultomiris is a good treatment option for you. Here are a few questions you may want to ask your doctor:

  • What can I do to manage certain side effects of Ultomiris?
  • Are there other treatment options with less risk of side effects for my condition?
  • Do I have a higher risk of side effects from this drug compared with other people?

Q:

Do I need to take antibiotics if I have not been vaccinated against meningococcal infections?

Anonymous

A:

If your meningococcal vaccinations are not up to date, your doctor will recommend that you receive the appropriate vaccines before you start Ultomiris treatment.

If you are vaccinated less than 2 weeks before starting Ultomiris treatment, you’ll likely need to take antibiotics for 2 weeks. The antibiotics help to prevent meningococcal infections before the vaccine starts working.

This is important because Ultomiris has a risk of meningococcal infections, which may lead to sepsis. In fact, Ultomiris has a boxed warning for this risk. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). (For more information about this warning, see the “Side effects explained” section above.)

Due to this risk, your doctor will not prescribe Ultomiris if you have a current meningococcal infection of if you haven’t been vaccinated against this kind of infection.

You may still get an infection if you take antibiotics and are vaccinated against meningococcal infections.

If you have any questions about Ultomiris and vaccinations, meningococcal infections, or antibiotics, ask your doctor.

The Healthline Pharmacist TeamAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.