Ultomiris is a brand-name intravenous (IV) infusion prescribed for certain rare autoimmune conditions. Ultomiris contains the active ingredient ravulizumab-cwvz and belongs to the complement inhibitors drug class.

Ultomiris is approved by the Food and Drug Administration (FDA)to treat the following conditions in adults and in children ages 1 month and older:

Additionally, Ultomiris is approved to treat the following conditions in adults:

  • Generalized myasthenia gravis (gMG). With gMG, your immune system blocks or destroys muscle receptor cells. Ultomiris is used in people with this condition who have anti-acetylcholine receptor (AChR) antibodies.
  • Neuromyelitis optica spectrum disorder (NMOSD). With NMOSD, your immune system damages cells in your eyes and spinal cord. Doctors may also call this condition neuromyelitis optica (NMO) or Devic’s disease.

* Note: Ultomiris is not approved to treat Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). STEC-HUS is a more common form of HUS, also called “typical HUS.”

Drug details

You’ll find key information about Ultomiris below.

  • Drug form: solution in a single-dose vial that’s given by intravenous (IV) infusion
  • Generic or biosimilar available? no, ravulizumab-cwvz* is available only as the brand-name drug Ultomiris
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: 2018

Ultomiris has a boxed warning. A boxed warning is the most serious warning from the FDA. For details, see the “Ultomiris precautions” section.

* The reason “-cwvz” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future.

Ultomiris contains the active drug ravulizumab-cwvz. It’s a biologic drug that’s available only as a brand-name medication. Ultomiris is not currently available in generic or biosimilar form.

A biologic drug is made using living organisms, while traditional drugs are made using chemicals. Exact copies of brand-name chemical drugs can be made. These are called generics. Generics are just as safe and effective as the original drug. And they usually cost less than the brand-name version.

It’s not possible to make exact copies of biologic drugs. Instead, manufacturers can sometimes make similar versions of brand-name biologic drugs. These are called biosimilars. Like generics, biosimilars are considered to be just as safe and effective as the parent drug they’re based on. And they usually cost less than the brand-name parent drug.

The Food and Drug Administration (FDA) approves prescription drugs such as Ultomiris to treat certain conditions. The use a drug is approved for is called its indication.

Ultomiris for paroxysmal nocturnal hemoglobinuria

Ultomiris is FDA-approved to treat a rare autoimmune and blood disorder called paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris is approved for this use in adults and in children ages 1 month and older.

With PNH, your body makes some irregular red blood cells. Your immune system destroys these cells through a process called hemolysis. When destroyed, your red blood cells release hemoglobin (a red pigment that carries oxygen). The hemoglobin leaves your body in your urine and can make your urine red or dark in color. This is called hemoglobinuria. However, not all people with PNH have this symptom.

With PNH, hemolysis happens all the time but may happen more at night (nocturnal). Hemolysis may also occur more often when your immune system is especially active. This could happen if you have an infection or injury or are experiencing stress. These triggers can cause paroxysmal (sudden) attacks of PNH, making your symptoms worse.

Hemolysis in PNH leads to anemia (low red blood cell count) and low hemoglobin levels. This can cause mild or severe symptoms, depending on your levels. Examples of anemia symptoms include:

Severe hemolysis can cause anemia, which may require treatment with blood transfusions. It can also cause other symptoms, such as difficulty swallowing or spasms in your abdomen or throat. It may also lead to erectile dysfunction (inability to maintain an erection) in males.*

Some people with PNH may also have problems with blood clotting. Blood clots can result from long-term hemolysis. But they may also occur due to irregular platelet cells that form due to PNH. These cells can form blood clots that can block blood flow to vital organs, especially your brain, liver, stomach, or kidneys. This can cause various symptoms, depending on the part of the body that’s affected.

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

Effectiveness for PNH

Ultomiris is an effective treatment for PNH. To find out how the drug performed in clinical trials, see the prescribing information for Ultomiris.

Ultomiris for atypical hemolytic uremic syndrome

Ultomiris is FDA-approved to treat a rare autoimmune and blood disorder called atypical hemolytic uremic syndrome (aHUS).* It’s approved for this use in adults and in children ages 1 month and older.

aHUS is a long-term disorder that’s usually triggered by an event, such as infection, pregnancy, cancer, injury, or surgery. With aHUS, your immune system damages small blood vessels in your body. This causes blood clots to form in these blood vessels.

The clots can block blood flow to vital organs, especially your kidneys. They can also prevent blood flow to your brain, heart, or digestive tract. This can lead to organ damage. With organ damage, your organs may slowly lose their ability to work properly or may suddenly fail. This can cause various symptoms, depending on what part of the body is affected.

These blood clots can also cause thrombocytopenia (low level of platelet cells in your blood) and hemolytic anemia (destroyed red blood cells).

Symptoms of aHUS may start slowly or can occur suddenly. Possible symptoms may include:

* Note: Ultomiris is not approved to treat Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). STEC-HUS is a more common form of HUS, also called “typical HUS.”

Effectiveness for aHUS

Ultomiris is an effective treatment for aHUS. To find out how the drug performed in clinical trials, see the prescribing information for Ultomiris.

Ultomiris for generalized myasthenia gravis

Ultomiris is FDA-approved to treat generalized myasthenia gravis (gMG). Ultomiris is used in people with this condition who have anti-acetylcholine receptor (AChR) antibodies.

With gMG, your immune system makes antibodies that attack muscle receptor cells. This prevents your muscles from receiving the signals they need to move, and it prevents your nerves from sending the signals to your muscles. This leads to symptoms such as muscle weakness and tiredness.

Effectiveness for gMG

Ultomiris is an effective treatment for gMG. To find out how the drug performed in clinical trials, see the prescribing information for Ultomiris.

Ultomiris for neuromyelitis optica spectrum disorder

Ultomiris is FDA-approved to treat neuromyelitis optica spectrum disorder (NMOSD). With NMOSD, your immune system damages cells in your eyes and spinal cord. Doctors may also call this condition neuromyelitis optica (NMO) or Devic’s disease.

Effectiveness for NMOSD

Ultomiris is an effective treatment for NMOSD. To find out how the drug performed in clinical trials, see Ultomiris’s prescribing information.

Ultomiris and children

Ultomiris is FDA-approved for use in children ages 1 month and older to treat the following rare autoimmune and blood disorders:

To learn about these disorders, see the “Ultomiris for paroxysmal nocturnal hemoglobinuria” and “Ultomiris for atypical hemolytic uremic syndrome” sections just above.

Ultomiris REMS program

Ultomiris can only be prescribed by doctors enrolled in the Ultomiris risk evaluation and mitigation strategy (REMS) program. REMS is a drug safety program created by the Food and Drug Administration (FDA). It makes sure certain drugs are used safely and given only by specially trained healthcare professionals.

The Ultomiris REMS program is used to manage the risk of serious meningococcal infection with the drug. Ultomiris has a boxed warning for this side effect. To read more about this, see “Serious meningococcal infections” under the “Ultomiris side effects” section.

Under the REMS program, your doctor will:

  • Give you information about the risk of serious meningococcal infections with Ultomiris treatment. They’ll also advise on what symptoms to look out for.
  • Make sure you’re up to date with meningococcal vaccines before you start Ultomiris treatment.
  • Give you a patient safety card to carry throughout your Ultomiris treatment. You’ll also carry it for 8 months after your last dose. Be sure to show this card to any doctor or healthcare professional who gives you treatment.

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

The Ultomiris dosage your doctor prescribes will depend on your body weight in kilograms (kg). (One kg is approximately 2.2 pounds [lb].)

You’ll start Ultomiris treatment with a loading dose. This dose helps get enough medication into your body to allow it to start working quickly. After this dose, you’ll continue treatment with a maintenance dose. This dose maintains a steady level of the drug in your body over time.

The following dosing information describes loading and maintenance dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

To learn more about dosages of Ultomiris, see this article.

Drug forms and strengths

Ultomiris comes as a solution in a single-dose vial in the following sizes and strengths:

  • 300 milligrams in 3 milliliters of solution (100 mg/mL)
  • 1,100 mg in 11 mL (100 mg/mL)
  • 300 mg in 30 mL (10 mg/mL)

Your doctor or another healthcare professional will administer Ultomiris by intravenous (IV) infusion.

Dosage for paroxysmal nocturnal hemoglobinuria

Ultomiris is approved to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults and in children ages 1 month and older.

You’ll start treatment with a loading dose. Then 2 weeks after, you’ll continue treatment with a maintenance dosage.

The dosage your doctor prescribes will be based on your body weight. The recommended dosages for PNH based on body weight are as follows:

Age groupBody weightBody weight in pounds (lb)Loading (starting) doseMaintenance (long-term) dosage
children ages 1 month and older5 kilograms (kg)* to less than 10 kgabout 11 lb to less than 22 lb600 milligrams (mg)300 mg every 4 weeks
children ages 1 month and older10 kg to less than 20 kgabout 22 lb to less than 44 lb600 mg600 mg every 4 weeks
children ages 1 month and older20 kg to less than 30 kgabout 44 lb to less than 66 lb900 mg2,100 mg every 8 weeks
children ages 1 month and older 30 kg to less than 40 kgabout 66 lb to less than 88 lb1,200 mg2,700 mg every 8 weeks
adults and children ages 1 month and older40 kg to less than 60 kgabout 88 lb to less than 132 lb2,400 mg3,000 mg every 8 weeks
adults and children ages 1 month and older60 kg to less than 100 kgabout 132 lb to less than 220 lb2,700 mg3,300 mg every 8 weeks
adults and children ages 1 month and older 100 kg or moreabout 220 lb or more3,000 mg3,600 mg every 8 weeks

* 1 kg is approximately 2.2 pounds (lb).

For example, if you weigh 65 kg (about 143 lb), your loading dose would be 2,700 mg. And then 2 weeks after, you’ll continue your treatment with a maintenance dosage of 3,300 mg every 8 weeks.

Note: Your doctor may switch your PNH treatment from eculizumab (Soliris) to Ultomiris. In this case, you’ll start Ultomiris treatment at the time of your next scheduled dose of Soliris.

Dosage for atypical hemolytic uremic syndrome

Ultomiris is used to treat atypical hemolytic uremic syndrome (aHUS) in adults and in children ages 1 month and older. The recommended dosages for aHUS are the same as the recommended dosages for PNH. These are described right above.

Dosage for generalized myasthenia gravis

Ultomiris is used to treat generalized myasthenia gravis (gMG) in certain adults. The recommended dosages for adults with gMG are the same as the recommended dosages for adults with PNH. These are described above.

Dosage for neuromyelitis optica spectrum disorder

Ultomiris is used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults. The recommended dosages for adults with NMOSD are the same as the recommended dosages for adults with PNH. These are described above.

Children’s dosage

Ultomiris is used to treat PNH and aHUS in children ages 1 month and older.

As with adults, the recommended children’s dosage of Ultomiris for PNH and aHUS is based on your child’s body weight in kg. The recommended dosages are described above.

What if I miss a dose?

If you miss an appointment for your Ultomiris infusion, call your doctor’s office right away to reschedule.

To help make sure that you don’t miss an infusion appointment, be sure to put your treatment schedule on your calendar. You could also download a reminder app on your phone.

Will I need to receive this drug long term?

Ultomiris is meant to be a long-term treatment. If you and your doctor determine that Ultomiris is safe and effective for you, you’ll likely take it long term.

Ultomiris is given by intravenous (IV) infusion. An IV infusion is an injection into a vein (usually in your arm) that’s given over a period of time. Ultomiris infusions may take between 25 minutes and 4 hours, depending on your dosage.

Your doctor or another healthcare professional will administer your Ultomiris infusion. Administration of this medication usually takes place in your doctor’s clinic or an infusion center. But in some cases, it may be possible to receive your infusions at home.*

* For more information, see “Can I have my Ultomiris infusions at home?” in the “Common questions about Ultomiris” section above.

When you’ll receive Ultomiris

You’ll start treatment with a loading dose of Ultomiris. This is to get enough medication into your body so that it starts working quickly.

Then 2 weeks after your loading dose, you’ll continue treatment with a maintenance dose. This dose maintains a steady level of the drug in your body over time. You may receive your maintenance dosage once every 4 or 8 weeks. Your dosage will depend on your body weight. (For more information, see the “Ultomiris dosage” section above.)

To help make sure you don’t miss an infusion appointment, be sure to put your treatment schedule on your calendar. You could also download a reminder app on your phone.

Ultomiris is prescribed to treat the following conditions:

About your immune system

Your immune system is a complicated network of proteins, cells, tissues, and organs that help protect you from disease. One part of your immune system is called the complement system. This is a group of proteins that work together with other parts of your immune system, such as white blood cells and antibodies. It helps find and destroy foreign or irregular material in your body.

What happens with PNH

With PNH, some of your red blood cells are missing a particular protein on their surface. This protein usually helps your immune system recognize red blood cells as a regular part of your body. Without it, your complement system sees these cells as irregular and destroys them. This can lead to anemia (low red blood cell levels) and low hemoglobin levels.*

Anemia causes symptoms such as fatigue and shortness of breath. Severe anemia due to PNH can cause atypical heart rhythm and chest pain. This usually requires treatment with blood transfusions. Long-term destruction of red blood cells can also cause problems with blood clotting.

* Hemoglobin is the red pigment in your red blood cells that carries oxygen.

What happens with aHUS

With aHUS, your immune system causes your complement system to function irregularly. For example, your complement system may destroy red blood cells, damage the lining of blood vessels, and cause blood clots to form in small blood vessels. This condition commonly affects the kidneys, which can lead to acute (short-term) kidney damage or failure.

Symptoms of aHUS can include severe fatigue, pale skin, and urinating less than usual. Other symptoms may include high blood pressure, swelling, and neurological problems such as seizures.

What happens with gMG

With gMG, your immune system makes antibodies that attack acetylcholine receptors, where your nerves connect to your muscles. These receptors usually send signals from your nerves to your muscles so your body can move. When these receptors are blocked or destroyed, your muscles can’t receive signals correctly. This causes muscle weakness and fatigue.

In people with gMG, muscle weakness is most likely to occur in the eyes, face, mouth, throat, and respiratory system. Symptoms can include drooping eyelids, double vision, and difficulty swallowing.

What happens with NMOSD

With NMOSD, your immune system makes antibodies that attack certain proteins on cells in your central nervous system (CNS), particularly cells in your optic nerves and spinal cord. This causes inflammation and damage in the body parts the condition affects.

In people with NMOSD, damage to your optic nerves can lead to symptoms such as pain and vision loss. Inflammation in your spinal cord can lead to damage in certain areas of brain.

What Ultomiris does

Ultomiris contains the active drug ravulizumab-cwvz. It belongs to a class of medications called complement inhibitors. Ultomiris works by blocking the action of a specific protein in the complement system called C5. By blocking the action of C5, Ultomiris stops activity in the complement system that causes the condition being treated. (The way a drug works is called its mechanism of action.)

In people with PNH, Ultomiris helps prevent the complement system from destroying your red blood cells. It helps stabilize your hemoglobin levels and reduces symptoms of anemia. It also decreases your risk of blood clots and your need for blood transfusions.

In people with aHUS, Ultomiris helps prevent the complement system from damaging your small blood vessels. This can help stop blood clots from forming in these vessels, which helps prevent organ damage. It also allows your platelet and red blood cell levels to return to usual.

In people with gMG, Ultomiris helps prevent the complement system from attacking nerve receptors in your muscles. This helps nerve signals reach your muscles. It also improves muscle strength and reduces muscle weakness and fatigue.

In people with NMOSD, Ultomiris helps prevent the complement system from attacking your CNS, particularly the optic nerves and spinal cord. This reduces inflammation and damage to these areas. It also helps prevent vision problems and other symptoms of the condition.

How long does it take to work?

Ultomiris starts working right after your first infusion. However, it may take a few weeks before your symptoms start to improve.

Here are answers to some frequently asked questions about Ultomiris.

How does Ultomiris compare with Soliris?

Ultomiris and Soliris are approved to treat the following conditions in certain people:

Ultomiris contains the active drug ravulizumab-cwvz. Soliris contains the active drug eculizumab. Both of these drugs are biologics called monoclonal antibodies. A biologic is a drug that’s made using living organisms. And a monoclonal antibody is a drug that targets a specific protein in your body. Ultomiris and Soliris both target an immune system protein called complement protein C5. This protein is involved in the development of PNH and aHUS.

Ultomiris and Soliris are given as an intravenous (IV) infusion by your doctor or another healthcare professional. Ultomiris is long-acting. This means the drug’s effects last a longer time in your body. So, you typically receive it once every 4 or 8 weeks. Soliris is shorter acting and you typically receive it once every 2 weeks.

These drugs have similar side effects, including a boxed warning for the risk of serious meningococcal infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about side effects that can be dangerous. For more information, see the “Ultomiris side effects” section later in the article.

If you’d like to learn more about how Ultomiris compares with Soliris, talk with your doctor.

Will Ultomiris be approved by the FDA to treat amyotrophic lateral sclerosis (ALS)?

No, it’s not likely. A clinical trial investigating Ultomiris for ALS was stopped in 2021. This was because early results didn’t find the drug to be effective for ALS.

ALS is a rare degenerative disease of the brain and nervous system. It causes loss of muscle function that gradually worsens and is eventually fatal. Currently, there isn’t a cure for ALS. However, the Food and Drug Administration (FDA) has approved two drugs that can help slow down progression of ALS. These drugs are riluzole (Rilutek) and edaravone (Radicava).

If you’re interested in finding a treatment for ALS, talk with your doctor.

Can I have my Ultomiris infusions at home?

Possibly. Your doctor may be able to prescribe Ultomiris IV infusions that you receive at home. If this applies to you, a healthcare professional from a home infusion service will give your infusion.

If you’re interested in receiving Ultomiris in the comfort of your own home, talk with your doctor. They can help determine if this solution is right for you.

Note: The cost of at home infusions will depend on your insurance plan and other factors. For more information, see the “Ultomiris cost” section below.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Ultomiris, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are used for conditions that Ultomiris is approved to treat:

  • eculizumab (Soliris)
  • pegcetacoplan (Empaveli)
  • epoetin alfa (Epogen, Procrit)
  • darbepoetin alfa (Aranesp)
  • inebilizumab-cdon (Uplizna)
  • satralizumab-mwge (Enspryng)
  • efgartigimod alfa-fcab (Vyvgart)
  • rozanolixizumab-noli (Rystiggo)
  • zilucoplan (Zilbrysq)
  • rituximab (Rituxan)
  • azathioprine

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is used for a purpose other than what it’s approved for.

As with all medications, the cost of Ultomiris can vary.

The actual price you’ll pay depends on your insurance plan, your location, and where you receive your infusions.

Before approving coverage for Ultomiris, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if it will cover the drug.

If you’re not sure if you’ll need to get prior authorization for Ultomiris, contact your insurance company.

In addition to the following information, you can see this article to learn about the cost of Ultomiris.

Financial and insurance assistance

If you need financial support to pay for Ultomiris, or if you need help understanding your insurance coverage, help is available.

Alexion, the manufacturer of Ultomiris, offers a program called OneSource. This program provides financial assistance and other types of support for people who qualify. For more information and to find out if you’re eligible for support, call 888-765-4747 or visit the program website.

To learn more about saving money on prescriptions, see this article.

Biosimilar version

Ultomiris contains the active drug ravulizumab-cwvz. It’s a biologic drug that’s available only as a brand-name medication. Ultomiris is not currently available in generic or biosimilar form.

A biologic drug is made using living organisms, while traditional drugs are made using chemicals. Manufacturers can make exact copies of brand-name chemical drugs. These are called generics. Generics are just as safe and effective as the original drug. And they usually cost less than the brand-name version.

It’s not possible to make exact copies of biologic drugs. Instead, manufacturers can sometimes make similar versions of brand-name biologic drugs. These are called biosimilars. Like generics, biosimilars are considered to be just as safe and effective as the parent drug they’re based on. And they usually cost less than the brand-name parent drug.

Drug coupons

You can visit Optum Perks for price estimates of Ultomiris. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

Ultomiris can cause mild or serious side effects. The following lists contain some of the key side effects that may occur during Ultomiris treatment. These lists do not include all possible side effects.

For more information about the possible side effects of Ultomiris, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Ultomiris, you can do so through MedWatch.

Mild side effects

Mild side effects* of Ultomiris can include:

* This is a partial list of mild side effects from Ultomiris. To learn about other mild side effects, talk with your doctor or pharmacist or view the prescribing information for Ultomiris.
† For more information about this side effect, see “Side effect details” below.

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Ultomiris aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Serious infections, such as pneumonia. Symptoms can include:
    • headache with nausea, vomiting, fever, stiff neck, or stiff back
    • fever with or without a skin rash
    • skin rash that doesn’t fade when pressed
    • sensitivity to light
    • confusion
    • sleepiness
    • cold hands and feet
    • flu-like symptoms with aching muscles or joints
    • cough
    • shortness of breath
  • Infusion-related reactions.*
  • Serious meningococcal infections, such as meningitis.†
  • Allergic reaction.*
  • Complications after stopping treatment with Ultomiris. New or worsening symptoms may include:
    • worsening of the condition that you were using Ultomiris to treat
    • shortness of breath
    • seizures
    • blood clots

* For more information about this side effect, see “Side effect details” below.
† Ultomiris has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Ultomiris.

Infusion-related reactions

You will receive Ultomiris by intravenous (IV) infusion. Some people may have infusion-related reactions with this medication. These are side effects that occur during or shortly after your infusion. In clinical trials, infusion-related reactions were rare with Ultomiris treatment.

Symptoms of infusion-related reactions may include:

What you can do

Your doctor or another healthcare professional will monitor you for infusion-related reactions during your Ultomiris infusion. They will also monitor you for at least 1 hour after your infusion.

If you have symptoms of a reaction, tell your doctor right away. They may give you medications to treat your symptoms as needed. And they may slow down or pause your infusion until your symptoms improve.

Upper respiratory tract infection

It’s possible to have upper respiratory tract infections, such as the common cold, during Ultomiris treatment. In clinical trials, these infections were among the more common side effects that people reported with Ultomiris.

Symptoms of upper respiratory tract infections may include:

  • sore throat
  • runny or stuffy nose
  • cough
  • sneezing

What you can do

If your symptoms bother you, talk with your doctor or pharmacist. They can recommend suitable over-the-counter medications to help ease your symptoms.

To help prevent these upper respiratory tract infections, try:

  • washing your hands often
  • avoiding close contact with people who have a cold
  • eating plenty of fruits and vegetables
  • getting plenty of sleep

Serious meningococcal infections

Ultomiris has a boxed warning for the risk of serious meningococcal infections. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.

In clinical trials, serious meningococcal infections were rare with Ultomiris treatment. However, these infections can be life threatening and even fatal if not recognized and treated quickly.

Ultomiris works by weakening part of your immune system. So, it can increase your risk of serious infections caused by meningococcal bacteria, such as bacterial meningitis.

Symptoms of serious meningococcal infections can include:

  • headache with nausea, vomiting, fever, stiff neck, or stiff back
  • fever with or without a skin rash
  • skin rash that doesn’t fade when pressed
  • sensitivity to light
  • confusion
  • sleepiness
  • cold hands and feet
  • flu-like symptoms with aching muscles or joints

You may also have an increased risk of this side effect for up to 8 months after your last dose of Ultomiris.

What you can do

Due to the risk of meningococcal infections, Ultomiris is only available under a risk evaluation and mitigation strategy (REMS) program. (To read more about the Ultomiris REMS program, see “Ultomiris REMS program” in the “Ultomiris uses” section below.)

Under the REMS program, your doctor will make sure you’re up to date with recommended meningococcal vaccines before starting Ultomiris treatment. If not, they’ll give you the vaccines at least 2 weeks before you start treatment. This will give the vaccines time to work.

If you need urgent treatment with Ultomiris, your doctor may want you to start Ultomiris sooner than 2 weeks after receiving the vaccines. In this case, you’ll likely also need to take antibiotics to help prevent meningococcal infections. You’ll take the antibiotics for the first 2 weeks after your first Ultomiris infusion.

Vaccines reduce the risk of serious meningococcal infections, but it’s still possible to get these infections. If you have symptoms of a serious meningococcal infection during Ultomiris treatment or in the 8 months after your last dose, see your doctor right away. But if your symptoms feel life threatening, call 911 or your local emergency number.

If you have a serious meningococcal infection, your doctor will prescribe antibiotics to treat it. They may also recommend pausing treatment with Ultomiris until the infection gets better.

Allergic reaction

As with most drugs, some people can have an allergic reaction after receiving Ultomiris.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • difficulty breathing

Call your doctor right away if you have an allergic reaction to Ultomiris, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Ultomiris isn’t prescribed with other drugs for the conditions it’s approved to treat. However, it might sometimes be used with other drugs to help prevent serious meningococcal infections.*

Due to this risk, your doctor will make sure you’re up to date with recommended meningococcal vaccines. If not, they’ll likely give you these vaccines at least 2 weeks before starting treatment. This gives the vaccines time to work.

However, if you need urgent treatment with Ultomiris, your doctor may want you to start Ultomiris sooner than 2 weeks after receiving the vaccines. In this case, you’ll likely also need to take antibiotics to help prevent meningococcal infections. You’ll take the antibiotics for 2 weeks after your first Ultomiris dose.

* Ultomiris has a boxed warning for the risk of serious meningococcal infections. For more information, see “Serious meningococcal infections” under the “Ultomiris side effects” section above.

Ultomiris is not known to interact with alcohol. However, if you have certain side effects with Ultomiris, such as headaches or dizziness, drinking alcohol could make them worse. (For more information about side effects, see the “Ultomiris side effects” section above.)

If you drink alcohol, talk with your doctor about how much, if any, is safe to drink while you’re receiving Ultomiris.

Ultomiris is not known to interact with other medications, herbs, supplements, or foods. The manufacturer of Ultomiris didn’t look at interactions in clinical trials of the drug.

But this doesn’t mean that interactions can’t happen with Ultomiris.

Before starting Ultomiris treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

It’ is unknown if Ultomiris is safe to take during pregnancy. This medication hasn’t been studied during pregnancy in humans.

In animal studies, eculizumab (Soliris), a drug similar to Ultomiris, caused congenital anomalies (commonly known as birth defects) when given to pregnant females. But keep in mind that animal studies don’t always predict what will happen in humans.

It’s important to note that if you’re pregnant and have one of the conditions Ultomiris is approved to treat, your condition has serious risks. Some of these risks can affect both you and your child. They include blood clots, bleeding, pregnancy loss, and premature delivery. (For more information about these conditions, see the “Ultomiris uses” section above.)

If you’re pregnant or planning to become pregnant, talk with your doctor about the possible risks related to your condition. Also talk with your doctor about the possible risks and benefits of Ultomiris treatment.

It is unknown if Ultomiris is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while receiving Ultomiris treatment.

For more information about receiving Ultomiris during pregnancy, see the “Ultomiris and pregnancy” section above.

You should not breastfeed during Ultomiris treatment and for 8 months after your last dose.

It is unknown if Ultomiris passes into breast milk. However, if it does, it could cause serious side effects in a child who’s breastfed. This is why your doctor will likely advise against breastfeeding during Ultomiris treatment and for 8 months after your last dose.

If you’re breastfeeding or plan to breastfeed, talk with your doctor about other healthy ways to feed your child while receiving Ultomiris treatment.

This drug comes with several precautions.

FDA warning: Serious meningococcal infections

This drug has a boxed warning about the following risk. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Ultomiris increases the risk of serious infections caused by meningococcal bacteria, such as bacterial meningitis. These infections can be life threatening and even fatal if not detected and treated quickly.

To reduce your risk of these infections, your doctor will make sure you’re up to date with recommended meningococcal vaccines. If not, they’ll likely give you these vaccines at least 2 weeks before starting Ultomiris treatment.

Vaccines reduce your risk of meningococcal infections, but these infections are still possible. So, it’s important to know the symptoms to look out for. For more information, see “Serious meningococcal infections” in the “Ultomiris side effects” section above.

Due to the risk of meningococcal infections, Ultomiris is only available under a risk evaluation and mitigation strategy (REMS) program. To learn more about this program, see the “Ultomiris uses” section above.

Other precautions

Before starting Ultomiris treatment, talk with your doctor about your health history. Ultomiris may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Infections: Ultomiris works by weakening part of your immune system. So, it can raise your risk of certain infections. These include gonorrhea and upper respiratory infections, such as the common cold. They also include serious infections, such as pneumonia. Before starting Ultomiris treatment, talk with your doctor about your vaccination history, risk of infections, and any current infections. They’ll likely recommend the pneumonia and meningitis vaccines if you have not had them.
  • Allergic reaction: If you’ve had an allergic reaction to Ultomiris or any of its ingredients, your doctor will likely not prescribe the drug. Ask your doctor about other medications that may be better options for you.
  • Pregnancy: It is unknown if Ultomiris is safe to use during pregnancy. For more information, see the “Ultomiris and pregnancy” section above.
  • Breastfeeding: You should not breastfeed during Ultomiris treatment and for 8 months after your last dose. For more information, see the “Ultomiris and breastfeeding” section above.

Note: For more information about the potential negative effects of Ultomiris, see the “Ultomiris side effects” section above.

Disclaimer: Medical News Today 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.

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