Pronunciation: ul-toe-meer-is
Generic name: ravulizumab
Dosage form: intravenous infusion, subcutaneous injection
Drug class: Selective immunosuppressants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Apr 15, 2025.

What is Ultomiris?

Ultomiris (ravulizumab-cwvz) infusion is a monoclonal antibody called a complement inhibitor used to treat autoimmune conditions like gMG, PNH, aHUS, and NMOSD, in certain patients. 

Ultomiris infusion is given every 8 weeks for adults and every 4 to 8 weeks for younger patients, as a maintenance dose. It is also available for adults as a subcutaneous injection administered through an on-body injector.

Common Ultomiris side effects are diarrhea, high blood pressure, stomach pain, upper respiratory tract infection, UTI, back pain, and dizziness.

Ultomiris is only available through the Ultomiris REMS program due to the risk of serious meningococcal infections.

Ultomiris only requires six to seven treatments a year for adults compared to other treatments.

What is Ultomiris used for? 

Ultomiris FDA-approved indications are:

• generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive
• paroxysmal nocturnal hemoglobinuria (PNH) in adults and children aged one month and older
• atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adults and children aged one month and older with (does not include Shiga toxin E. coli-related hemolytic uremic syndrome [STEC-HUS])
• neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.

​​How does Ultomiris work?

Ultomiris's mechanism of action is as a monoclonal antibody complement inhibitor (C5).

Ultromiris works by blocking part of the immune system called the complement system. It specifically targets and inhibits the C5 protein, which plays a key role in immune responses. Ultromiris binds to the C5 protein and prevents it from being activated. This stops the immune system from mistakenly attacking healthy cells, which helps reduce symptoms and prevent disease progression.

Monoclonal antibodies are lab-made proteins designed to attach to specific targets, Ultromiris targets C5. The precise way Ultomiris infusion works is unknown but it is thought to be due to a reduction or inhibition of C5b-9 deposition. 

Ultomiris Clinical Trial Results

Improvement in Myasthenia Gravis (gMG) Symptoms

Ultomiris has been shown to reduce symptoms of generalized myasthenia gravis, as measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. This scale ranges from 0 to 24, with higher scores indicating more severe impairment.

Key Findings from Clinical Trial ALXN1210-MG-306 (NCT03920293)

At 26 weeks, patients treated with Ultomiris showed significant improvement:

• 30% of patients experienced at least a 5-point improvement in MG-ADL (vs. 11.3% in placebo)
• 56.7% of patients had at least a 3-point improvement in MG-ADL (vs. 34.1% in placebo)
• The least squares (LS) mean MG-ADL score improved by -3.1 (vs. -1.4 in placebo).

Additional Clinical Trial Data

Clinical trial results of Ultomiris in hemolytic uremic syndrome (aHUS), paroxysmal nocturnal hemoglobinuria (PNH), and neuromyelitis optica spectrum disorder (NMOSD) are available in the Ultomiris Package Insert - Clinical Studies.

Ultomiris side effects

Common Ultomiris side effects

Common side effects of Ultomiris in gMG may include:

• Diarrhea (15%)
• high blood pressure (14%)
• Stomach pain (6%)
• Upper respiratory tract infection (14%)
• Urinary tract infection (6%)
• Back Pain (8%)
• Dizziness (9%).

These side effects occurred in 5% or more of generalized myasthenia gravis patients treated with Ultomiris (ravulizumab) in the Clinical Trial ALXN1210-MG-306.

Side effects vary depending on the condition being treated and the dose given.

Serious Ultomiris side effects

Get emergency medical help if you have signs of an allergic reaction with symptoms of hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed or if you have chest pain, trouble breathing, or swelling in your face.

Call your healthcare professional (HCP) right away if you have signs of infection such as:

• muscle pain with flu-like symptoms;
• fever and a rash;
• fever and a headache;
• headache and stiffness in your neck or back;
• headache and nausea or vomiting;
• confusion; or
• your eyes may be more sensitive to light.

Call your doctor at once if you have symptoms of gonorrhea, such as:

• pain or burning when you urinate;
• pain or swelling of the genital or rectal area;
• unusual vaginal bleeding; or
• foul discharge from the penis or vagina.

If you stop using this medicine, tell your doctor if you have any new or worsening symptoms, such as tiredness, confusion, stomach pain, chest pain, trouble breathing or swallowing, trouble having an erection (in men), blood in your urine, a seizure, or loss of consciousness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Ultomiris for Myasthenia Gravis

Understanding Myasthenia Gravis

Myasthenia gravis (MG) is a neuromuscular disorder caused by disrupted nerve-to-muscle communication at the neuromuscular junction. This occurs when the immune system attacks healthy cells or proteins needed for normal function, which prevents proper muscle activation.

If myasthenia gravis is AChR antibody-positive, the condition is specifically caused by antibodies targeting acetylcholine receptors.

How Ultomiris Works for Myasthenia Gravis

Ultomiris is a complement inhibitor that blocks complement (C5), part of the immune system, responsible for damaging the neuromuscular junction. By reducing this immune attack, Ultomiris helps improve muscle function and symptoms in people with myasthenia gravis.

Ultomiris REMS Program 

Due to the risk of serious meningococcal infections, Ultomiris is only available through a restricted Risk Evaluation and Mitigation Strategy (REMS) program known as Ultomiris REMS. This program ensures patient safety by reducing the risk of life-threatening infections.

Steps Required Before Starting Ravulizumab (Ultomiris REMS Program)

Before receiving Ultomiris, your doctor must:

• Enroll you in the REMS program.
• Explain the risks of meningococcal infections.
• Provide information on early symptoms of infection and the need for immediate medical attention.
• Confirm meningococcal vaccination and, if needed, provide preventive antibiotics if treatment must start before full vaccination.
• Give you a Patient Safety Card outlining the risk of infection.

 Important: Meningococcal vaccines do not prevent all infections. Seek emergency medical care if you experience any of the following symptoms:

Signs of a Serious Meningococcal Infection

• High fever or fever with rapid heart rate
• Severe headache with fever
• Confusion or disorientation
• Muscle aches with flu-like symptoms
• Fever with a rash
• Headache with nausea or vomiting
• Stiff neck or back
• Light sensitivity (photosensitivity)

Warnings

Ultomiris infusion 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 ravulizumab unless the risks of delaying ravulizumab 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 ravulizumab 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.

This medicine should not be started in patients with unresolved serious Neisseria meningitidis infection.

Before taking this medicine

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

• are allergic to the active ingredient ravulizumab or any inactive ingredients.
• have a meningococcal infection (such as meningitis or sepsis), or if you are not currently vaccinated against meningitis (unless the risks of delaying treatment outweigh the risks of developing meningitis). You will need to receive a vaccine to protect against meningococcal infections at least 2 weeks before you start using Ultomiris. 
• If your child is treated with this medicine, make sure he or she is vaccinated against pneumonia and influenza type B (Hib). If you need to start receiving this medicine before you are vaccinated, you may be given antibiotic medicine to take during the first 2 weeks of Ultomiris treatment.
• have recently had any symptoms of an infection (fever, chills, or flu-like symptoms) or recently have had meningitis
• are pregnant or intend to become pregnant
• are breastfeeding or intend to breastfeed.

Ultomiris infusion is only approved for patients 1 month and older for PNH and aHUS. For other indications (gMG and NMOSD) it is only approved for adults. Subcutaneous administration of Ultomiris has not been evaluated and is not approved for use in children.

Pregnancy

It is not known if this medicine will harm your unborn baby. Tell your doctor if you are pregnant. 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.

Breastfeeding

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

How is Ultomiris administered?

Intravenous (IV) infusion by a healthcare provider

Ultomiris is given as an intravenous (IV) infusion by a healthcare professional.

The first two infusions are usually 2 weeks apart, followed by maintenance infusions every 4 to 8 weeks (dependant on weight).

The infusion time ranges from 0.4 to 1.4 hours, depending on body weight and dosage.

After each infusion, patients are monitored for at least 1 hour for any signs of an allergic reaction.

Dosage & weight considerations

Dosages are weight-based, meaning your dose may change if you gain or lose weight.

If switching from eculizumab (Soliris), you must wait 2 weeks after your last eculizumab dose before starting Ravulizumab.

Important safety information

Infection risks and monitoring

Increased risk of infections, you may get infections more easily, including serious or fatal infections. Regular medical tests are required.

The Patient Safety Card and carry it with you at all times while on Ravulizumab and for at least 8 months after the last dose.

Infection risk may continue for several months after stopping treatment.

Risk of gonorrhea (sexually transmitted infection)

Some patients may have a higher risk of gonorrhea.

Talk to your doctor about safe practices to prevent infection.

Long-lasting effects after stopping treatment

For Paroxysmal Nocturnal Hemoglobinuria (PNH): Monitoring is needed for at least 16 weeks after stopping treatment.

For Atypical Hemolytic Uremic Syndrome (aHUS): Patients should be monitored for at least 12 months after stopping ravulizumab.

Ultomiris dosage information

Dosing is based on weight, and whether it's a loading or maintenance dose:

Patients 5 kg – 20 kg: Maintenance dose every 4 weeks.

Patients 20 kg – 100+ kg: Maintenance dose every 8 weeks.

See, below for detailed "Detailed Ultomiris dosage information" including loading dose by weight and condition.

What is Ultomiris J Code?

Ultomiris J code is J1303 (10 mg, injection)

J codes are used for medicines that are not taken orally and include injections, inhalations, and chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.

Your physician will need Ultomiris J code when filling out forms for your treatment.

What happens if I miss a dose?

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

Ultomiris Package Insert 

HCPs and patients often use the Ultomiris Package Insert (Ultomiris) for more detailed information about this medicine. The PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Ultomiris Prescribing Information (PI) or Ultomiris FDA label.

What other drugs will affect this medicine?

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.

• A supplemental dose of Ultomiris is required for patients administered intravenous immunoglobulins or undergoing plasma exchange, plasmapheresis
• Monitor patients taking neonatal Fc Receptor Blockers (FcRn), such as efgartigimod or rozanolixizumab, closely for reduced effectiveness of Ultomiris.

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.

This list may not be complete.

Storage

Proper Storage Instructions:

Temperature: Keep refrigerated at 2°C - 8°C (36°F - 46°F).

Packaging: Store in the original carton to protect from light.

Do Not: Freeze or Shake the vial.

Storage After Dilution:

If not used immediately, store the prepared infusion in the refrigerator at 2°C - 8°C (36°F - 46°F).

Do not exceed 24 hours in storage, including the expected infusion time.

Always follow the product guidelines for proper handling and administration.

Ingredients

Active ingredient: ravulizumab-cwvz. 

Inactive ingredients: 

Ultomiris 100 mg/mL: L-arginine, polysorbate 80 (vegetable origin), sodium phosphate dibasic, sodium phosphate monobasic, sucrose, and Water for Injection. 

Ultomiris 10 mg/mL: polysorbate 80 (vegetable origin), sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, and Water for Injection. 

Manufacturer

Manufactured by Alexion Pharmaceuticals, Inc., 121 Seaport Boulevard, Boulevard Boston, MA 02210 USA.

Ultomiris Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Ultomiris.

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Further information

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

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