Ultomiris
Ultomiris (ravulizumab or ravulizumab-cwvz) is a type of monoclonal antibody called a complement inhibitor. This medication is used to treat adults and children with certain autoimmune conditions that affect the blood or nerves. It's given as an infusion through the veins (IV) once every 1 or 2 months. For certain adults, the medication can also be injected under the skin (subcutaneous) once per week. Side effects include upper respiratory tract infections and headache. Ultomiris (ravulizumab) is available only through the FDA’s Ultomiris REMS program because of the risk for serious meningococcal infections.
What is Ultomiris (ravulizumab)?
What is Ultomiris (ravulizumab) used for?
How Ultomiris (ravulizumab) works
Paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD) are autoimmune conditions that are caused by an overactive immune system that starts to attack the body by mistake. Proteins in your immune system called complement proteins play a key role in causing these autoimmune conditions.
Ultomiris (ravulizumab) is a monoclonal antibody that works as an complement inhibitor. The exact way that the medication works isn't completely clear. But it's thought to block complement proteins called C5. This helps stop your immune system from being overactive and from attacking different parts of your body.
Drug Facts
More on Ultomiris (ravulizumab) essentials
What are the side effects of Ultomiris (ravulizumab)?
Common Side Effects
Note: Side effects reported by adults with PNH getting IV infusions of Ultomiris (ravulizumab)
- Upper respiratory tract infection (39%)
- Headache (32%)
- Headache (40%)
- Diarrhea (31%)
- Nausea (26%)
- Vomiting (26%)
- Upper respiratory tract infection (26%)
- High blood pressure (24%)
- Joint pain (22%)
- Fever (19%)
- Cough (17%)
- Shortness of breath (17%)
- Swelling in arms or legs (17%)
- Urinary tract infection (17%)
- Diarrhea (15%)
- Upper respiratory tract infection (14%)
- COVID-19 infection (24%)
- Headache (24%)
- Back pain (12%)
- Joint pain (10%)
- Urinary tract infection (10%)
Other Side Effects
- Diarrhea
- Nausea
- Stomach pain
- Pain in arms, legs, or joints
- Fever
- Dizziness
- Tiredness
- Anxiety
- Constipation
- Stomach infections
- Stomach pain
- Pain in arms and legs
- Back pain
- Muscle spasm
- Hair loss
- Dry skin
- Dizziness
- Back pain
- Stomach pain
- Urinary tract infection
- Upper respiratory tract infection
- Fever
- Constipation
- Vomiting
- Dizziness
Serious Side Effects
- Serious infections (including meningococcal infections): fever, weakness, chills, trouble breathing, cough, diarrhea, stomach pain, burning when you urinate, urinating more or less often, neck pain, neck stiffness, confusion, severe headache
- Severe allergic reaction: rash, trouble breathing, feeling faint, swelling of the face or throat
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, neck pain or stiffness, sensitivity to light, headache, nausea, vomiting, confusion, which may be signs of meningitis
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
- Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Ultomiris (ravulizumab)
Pros
Can be given to adults and children 1 month of age and older (for PNH and aHUS)
IV infusions generally given every 1 or 2 months (except for first few doses)
Adults with certain autoimmune conditions have option of weekly, under-the-skin injections at home
Cons
Appointments for IV infusion can last a few hours
Raises the risk of serious infection
Might need to follow up with your healthcare team even after you stop treatment because of risk for complications
Pharmacist tips for Ultomiris (ravulizumab)
Before you start Ultomiris (ravulizumab), you'll need to be fully vaccinated against meningococcal disease (e.g., meningitis). Since this medication can put you at risk for infection, getting vaccinated helps lower your risk for serious meningococcal disease during treatment. You might be prescribed antibiotics to help prevent infections depending on if and when you complete your vaccines.
Ask a member of your care team whether you need to get any vaccinations before and during treatment with Ultomiris (ravulizumab) to help lower your risk for infections. Besides meningococcal disease, the medication can also put you at risk for other serious infections.
Avoid getting sick by washing your hands often and keeping away from people who are sick. Get medical help right away if you have symptoms of an infection (e.g., fever, cough, trouble breathing, weakness, sweating, chills, neck pain or stiffness) while you're taking Ultomiris (ravulizumab). You might have to stop taking the medication so your body can fight and fully recover from the infection.
Carry the Ultomiris Patient Safety Card that your care team gave you at all times so you know when to get medical help. This card describes all the symptoms of meningococcal infections you should look out for. Continue to carry this card for 8 months after you stop treatment because you're still at risk for serious infection during that time.
Call your prescriber to discuss what the next steps are if you accidentally miss a dose of Ultomiris (ravulizumab).
More tips for Ultomiris (ravulizumab) IV infusions:
Mark your appointments on your calendar to go to the medical office and get your Ultomiris (ravulizumab) IV infusion. This helps you remember to get your infusions on time so you don't miss any doses. It also makes sure your treatment is monitored properly.
Depending on your dose, your Ultomiris (ravulizumab) infusion can sometimes take several hours. You'll also need to stay at the medical office or infusion center for at least 1 hour to check for reactions to the medication. Be sure to plan ahead for your appointment and bring something to do to pass the time.
Tell your care team if you have any reactions during or after your Ultomiris (ravulizumab) infusions. Reactions can include changes in taste, sleepiness, trouble breathing, lower back pain, or arm or leg discomfort. Your care team can provide or recommend treatment.
More tips for how to inject Ultomiris (ravulizumab) under the skin at home:
Each carton of Ultomiris (ravulizumab) has one prefilled cartridge containing 245 mg/3.5 mL of medication and one on-body injector. The typical dose is 490 mg per week, so you'll need to use two cartridges and two on-body injectors for each dose. You can use the two sets for your dose at the same time or one after the other.
Make sure you know how to prepare the Ultomiris (ravulizumab) on-body injector and inject the medication properly. Carefully read the instructions for use, and contact your care team or pharmacist if you have any questions.
Keep Ultomiris (ravulizumab) cartridges and on-body injectors in the refrigerator in the original carton and away from light. Once they're taken out of the refrigerator, they're good for 3 days. Don't put the cartridges and on-body injectors back in the refrigerator after they reach room temperature.
When it's time for your dose, take two on-body injectors and two cartridges out of the refrigerator and let them reach room temperature for at least 45 minutes. Don't warm up the medication any other way (e.g., microwave, under hot water); this could damage it.
Before you inject, check that the solution is clear to a yellowish color. Don't use the medication if it's cloudy, discolored, or contains particles. Contact your care team or pharmacist for a replacement.
Inject Ultomiris (ravulizumab) under the skin into the stomach (at least 2 inches away from the belly button), thigh, or upper arm. Choose a different area to inject each week to lessen skin irritation. Don't inject into tender, bruised, red, or hard skin to prevent more damage to the skin. Avoid places with tattoos, scars, or stretch marks because you might not absorb the medication well through these areas.
It'll take about 10 minutes to inject the medication from each on-body injector and cartridge. Make sure you plan your day to give yourself enough time to prepare and administer Ultomiris (ravulizumab).
Throw away each used Ultomiris (ravulizumab) on-body injector and prefilled cartridge by placing them in a sharps container or something made of heavy-duty plastic (e.g., empty milk carton, laundry detergent bottle). This lowers the risk of needle-stick injuries. Don't throw them away in the trash. Visit the FDA's website to learn more about following your state regulations to dispose your sharps safely.
After each Ultomiris (ravulizumab) dose, be sure to watch out for any reactions to the medication for at least 1 hour. Call your care team if you have reactions like bad taste in the mouth, sleepiness, trouble breathing, lower back pain, or arm or leg pain at any time during treatment. Your care team can recommend ways to relieve them.
Frequently asked questions about Ultomiris (ravulizumab)
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What are the risks and warnings for Ultomiris (ravulizumab)?
Ultomiris (ravulizumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious infections (especially meningococcal infections)
Risk factors: Current infection | Past infections that keep coming back | Other conditions that raise your risk of infection | Taking medications that weaken your immune system
Ultomiris (ravulizumab) can affect the body's ability to fight off infections. This can raise the risk for serious infections, especially meningococcal infections like meningitis. Other infections can include pneumonia, Haemophilus influenzae disease (Hib disease), and sometimes gonorrhea.
Before you start Ultomiris (ravulizumab), you must be up-to-date on your meningococcal vaccinations to help lower your risk for serious meningococcal infection. Your prescriber will check whether you need any other vaccinations or preventative antibiotics before and during treatment. Call your healthcare team right away if you notice any signs of infection, like fever, chills, body aches, cough, nausea, vomiting, eyes that are sensitive to light, neck pain or stiffness, severe headache, or confusion.
Because of the risk for serious meningococcal infections, Ultomiris (ravulizumab) is only available through a restricted Risk Evaluation and Mitigation Strategies (REMS) program called Ultomiris REMS. Your prescriber must enroll in this program to prescribe the medication to you. Your prescriber must also talk with you about the risk for meningococcal infections and how to best protect against them.
Problems that happen after you stop treatment - for people with PNH or aHUS only
In people with PNH, stopping treatment can cause red blood cells to break down. After you stop Ultomiris (ravulizumab), your prescriber will monitor you for at least 4 months for any problems. You might need blood tests done so your prescriber can check for any complications. Tell your care team if you have any symptoms of this problem, such as tiredness, shortness of breath, dark-colored urine, stomach pain, or blood clots.
In people with aHUS, stopping treatment can cause complications of aHUS called thrombotic microangiopathy (TMA). TMA happens when your body forms blood clots in your small blood vessels. It can also cause low red blood cell counts, low platelet levels, and organ damage. After you stop Ultomiris (ravulizumab), your prescriber will monitor you for at least a year for this clotting problem. You might need blood tests to check for TMA. Call your care team if you have any symptoms of TMA, like chest pain, shortness of breath, confusion, seizures, blood clots, or high blood pressure.
Infusion-related reactions and allergic reactions
Although rare, there's a risk of serious infusion-related reactions and allergic reactions with Ultomiris (ravulizumab) treatments. These reactions can include lower back pain, sudden changes in blood pressure, arm or leg pain, bad taste in your mouth, and sleepiness. More serious and life-threatening reactions, such as anaphylaxis, chest pain, trouble breathing, and swelling of the face or tongue, can also happen.
Watch for infusion-related and allergic reactions for at least 1 hour after each Ultomiris (ravulizumab) dose. For IV infusions, your healthcare team will observe you during this time as well. Let your care team know if you have any signs of an infusion-related reaction or allergic reaction. And get medical help right away if you start swelling in the face or tongue or have trouble breathing.
Allergy to acrylic adhesives - for Ultomiris (ravulizumab) on-body injector only
The Ultomiris (ravulizumab) on-body injector uses acrylic adhesives to help the device stick to your skin for under-the-skin injections. Tell your healthcare team about any allergies before you start treatment. You're at risk for allergic reactions if you have an allergy to acrylic adhesive and you use the on-body injector. Get medical care right away if you have an allergic reaction after you use the on-body injector.
Ultomiris (ravulizumab) dosage forms
Typical dosing for Ultomiris (ravulizumab)
Treatment starts with a loading dose of Ultomiris (ravulizumab).
Loading dose: The loading dose is given as an infusion into the veins (intravenous or IV) as a single dose. Your prescriber will calculate your dose based on why you need the medication and your age and weight.
Treatment continues with routine maintenance doses of Ultomiris (ravulizumab), generally starting 2 weeks after the loading dose.
Maintenance doses: Maintenance doses are typically given as IV infusions. Certain adults have the option of getting maintenance doses as injections under the skin (subcutaneous or SC).
IV infusion: Your prescriber will calculate your dose based on your condition, age, and weight. After the first maintenance dose, Ultomiris (ravulizumab) is given once every 1 or 2 months.
SC injection (certain adults only): Maintenance doses given under the skin are only for adults with PNH or aHUS who weigh at least 88 lbs. The typical dose is 490 mg injected under the skin. After the first maintenance dose, Ultomiris (ravulizumab) is injected under the skin once per week.
You might need an extra (supplemental) dose of Ultomiris (ravulizumab) if your treatment plan includes plasmapheresis, plasma exchange, or IV immunoglobulin. These therapies can lower the amount of Ultomiris (ravulizumab) in your body.
Ultomiris (ravulizumab) contraindications
Current infection caused by the bacteria Neisseria meningitidis (meningococcal disease)
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References
Best studies we foundAfshar-Kharghan, V., et al. (2016). Atypical hemolytic uremic syndrome. Hematology, The American Society of Hematology Education Program.
Alexion Pharmaceuticals Inc. (2022). Patient safety card: Important safety information for patients taking Ultomiris® (ravulizumab-cwvz).
Alexion Pharmaceuticals Inc. (2024). Ultomiris- ravulizumab solution, concentrate; ravulizumab [package insert]. DailyMed.
Aplastic Anemia and MDS International Foundation. (n.d.). Paroxysmal nocturnal hemoglobinuria (PNH).
Arnold, D. M., et al. (2017). Thrombotic microangiopathies: A general approach to diagnosis and management. Canadian Medical Association Journal.
Bobati, S. S., et al. (2017). Therapeutic plasma exchange - An emerging treatment modality in patients with neurologic and non-neurologic diseases. Journal of Clinical and Diagnostic Research.
Borisow, N., et al. (2018). Neuromyelitis optica spectrum disorders and pregnancy: Relapse-preventive measures and personalized treatment strategies. The EPMA Journal.
Centers for Disease Control and Prevention. (n.d.). Haemophilus influenzae disease.
Centers for Disease Control and Prevention. (n.d.). Meningococcal disease.
Delves, P. J. (2024). Innate immunity. Merck Manual Consumer Version.
Gaggl, M., et al. (2018). Maternal and fetal outcomes of pregnancies in women with atypical hemolytic uremic syndrome. Journal of the American Society of Nephrology.
Iacomino, N., et al. (2022). Complement activation profile in myasthenia gravis patients: Perspectives for tailoring anti-complement therapy. Biomedicines.
Lee, J. W., et al. (2019). Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: The 301 study. Blood.
National Institute of Neurological Disorders and Stroke. (2024). Myasthenia gravis.
National Multiple Sclerosis Society. (2022). Neuromyelitis optica spectrum disorder (NMOSD).
Patel, A., et al. (2017). Paroxysmal nocturnal hemoglobinuria in pregnancy: A dilemma in treatment and thromboprophylaxis. Case Reports in Hematology.
Sergent, S. R., et al. (2023). Plasmapheresis. StatPearls.
U.S. Food and Drug Administration. (2021). Safely using sharps (needles and syringes) at home, at work and on travel.
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