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Pronunciation: ul-toe-meer-is
Generic name: ravulizumab
Dosage form: injection for intravenous or subcutaneous use
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 2, 2024.

What is Ultomiris?

Ultomiris (ravulizumab-cwvz) is an injectable complement inhibitor that may be used to:

Ultomiris works by inhibiting the activity of the complement system, which is part of the immune system. It specifically binds to complement protein C5 with high affinity, inhibiting its cleavage to C5a (a proinflammatory toxin) and C5b (which initiates the membrane attack complex (MAC or C5b-9) which leads to osmolysis and the rupture of the cell wall.  Ultomiris prevents complement-mediated red blood cell rupture in patients with PNH and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS. The exact way Ultomiris works for gMG or NMOSD is unknown but is thought to involve decreased deposition of C5b-9.

Ultomiris is a monoclonal antibody. Monoclonal antibodies are man-made antibodies that fight antigens (harmful substances) in the body. It affects your immune system and may lower the ability of your body to fight infections.

Ultomiris is available only under a special program called the Ultomiris and Soliris REMS. Before you can receive it, your healthcare provider must:

Ultomiris was FDA-approved on December 21, 2018.


Ultomiris affects your immune system. You may get infections more easily, even serious or fatal infections, such as meningitis. Call your doctor if you have a fever, flu-like symptoms, muscle pain, headache, confusion, neck or back stiffness, vomiting, rash, or if your eyes are more sensitive to light.

You will need to receive certain vaccinations, including vaccinations to protect against meningococcal disease, at least 2 weeks before you start using Ultomiris, unless the risks of delaying Ultomiris outweigh the risks of a serious infection.

Ultomiris comes with a Patient Safety Card listing symptoms of meningococcal infection. Keep this card with you at all times while using Ultomiris and for at least 8 months after your last dose. Your infection risk could last for several months after you stop using this medicine.

Some people may have an increased risk of gonorrhea (a sexually transmitted disease) while using this medicine. Talk with your doctor about safe ways to keep from getting an infection during sex.

Before taking

Before you receive Ultomiris, tell your healthcare provider about all of your medical conditions, including if you:

Ultomiris is not approved for use in PNH by anyone younger than 1 month old. For other indications (such as gMG and NMOSD), it is not approved for use in children. Subcutaneous administration of Ultomiris has not been evaluated and is not approved for use in children.


It is not known if Ultomiris will harm your unborn baby. Tell your doctor if you are pregnant. It is not known whether ravulizumab will harm an unborn baby. However, having PNH during pregnancy may cause complications in the baby or the mother, including blood clots, infections, bleeding, miscarriage, premature delivery, or death. The benefit of treating PNH may outweigh any risks to the baby or the mother.


It is not known if Ultomiris passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose.

How is Ultomiris administered?

Ultomiris is administered either as an intravenous (into a vein) infusion by a healthcare provider or self-administered by subcutaneous (under the skin) injection through an on-body injector.

Intravenous administration

Ultomiris is given by infusion. The time it takes to administer the infusion ranges from a minimum of 0.4 hours to 1.4 hours and depends on body weight and dosage. Your dose may change if you gain or lose weight. See the product information for minimum infusion times.

In children aged 1 month and older with PNH or aHUS, the infusion is usually given every 4 weeks or every 8 weeks, depending on their weight, starting 2 weeks after the starting dose.

Subcutaneous administration

For adults with PNH or aHUS, Ultomiris may be administered subcutaneously (SC) through an on-body injector. Usually, the very first dose is given as an intravenous infusion by your healthcare provider.

Subcutaneous injections of Ultomiris are usually given weekly.

Stopping treatment

Your healthcare provider will tell you how long you should stay on Ultomiris.

If you have PNH and you stop receiving Ultomiris, your healthcare provider will need to monitor you closely for at least 16 weeks after you stop receiving it. Stopping Ultomiris may cause a breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include:

If you have aHUS, your healthcare provider will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include:

What happens if I miss a dose?

If you miss an Ultomiris IV or SC  dose or administer a partial SC dose, call your healthcare provider right away.

What are the side effects of Ultomiris?

Ultomiris can cause the following serious side effects.

An increased risk of developing serious meningococcal infections caused by Neisseria meningitidis bacteria.

These may quickly become life-threatening or cause death if not recognized and treated early.

Other serious infections

Other types of serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.


Certain people may be at risk of serious infections with gonorrhea. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.

Infusion-related reactions

These may happen during your IV or SC treatment.  Symptoms of an infusion-related reaction may include lower back pain, abdominal pain, muscle spasms, changes in blood pressure, tiredness, feeling faint, shaking chills (rigors), discomfort in your arms or legs, bad taste, or drowsiness. Stop Ultomiris and tell your healthcare provider right away if you develop these symptoms, or any other symptoms during your infusion that may mean you are having a serious infusion-related reaction, including:

Allergic reactions to the acrylic adhesive used on the on-body injector

If you have an allergic reaction during the delivery of SC Ultomiris, remove the on-body injector and get medical help right away. Your healthcare provider may treat you with medicines to help prevent or treat allergic reaction symptoms as needed.

The most common side effects of Ultomiris reported, regardless of the condition being treated, include:

Report suspected side effects to Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at 1-800-FDA-1088 or

What other drugs will affect Ultomiris?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ultomiris and other medicines can affect each other causing side effects.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.


Ultomiris vials for intravenous infusion

Store refrigerated at 2°C - 8°C (36°F - 46°F) in the original carton to protect from light. Do not freeze. Do not shake. The vial requires dilution (refer to the product information).

If the infusion is not used immediately, store in the refrigerator at 2°C - 8°C (36°F - 46°F) for no longer than 24 hours taking into account the expected infusion time.

Ultomiris prefilled cartridges and on-body injector for subcutaneous administration

Store prefilled cartridges and on-body injectors refrigerated at 2°C - 8°C (36°F - 46°F) in the original carton to protect them from light and physical damage. Do not freeze. Do not shake or drop.

The single-use on-body injector with a prefilled cartridge is not made with natural rubber latex.


Active ingredient: ravulizumab-cwvz.

Inactive ingredients (intravenous injection):

Inactive ingredients (subcutaneous injection):


Alexion Pharmaceuticals, Inc.

Popular FAQ

In general, minimum intravenous (IV) infusion times for Ultomiris range from about 24 minutes to almost 4 hours. Your infusion time is based on your weight, dose, if you are receiving a loading dose or maintenance dose and why you are receiving it. You may also be monitored in the clinic for at least 60 minutes after the infusion for an allergic reaction.

Ultomiris (ravulizumab) and Soliris (eculizumab) are both C5 complement inhibitors approved to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), a blood disease caused by red blood cell destruction. Ultomiris has a longer half-life, meaning it stays in your blood longer and does not have to be dosed as often.  Continue reading

In general, minimum infusion times for Ultomiris can range from 0.4 hours to 3.8 hours. The infusion time is based on the patient’s weight, the prescribed dose and if it is a loading dose or maintenance dose. Patients are also monitored for at least one hour after the IV infusion for infusion-related reactions.  Continue reading


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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.