Ultomiris (ravulizumab)
An approved treatment for Neuromyelitis Optica Spectrum Disorder.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Ravulizumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Ravulizumab
- Brand name
- Ultomiris
- Development code
- ALXN1210
- Drug class
- Complement C5 inhibitor
- Manufacturer
- Alexion, AstraZeneca Rare Disease
- How it's taken
- IV infusion every 8 weeks after a weight-based loading dose.
A long-acting complement C5 inhibitor approved on March 22, 2024 for adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. After a weight-based loading dose, it is an IV infusion every 8 weeks. In its main trial, no one on Ultomiris had a confirmed relapse over a median of about 73 weeks, compared with a placebo group from an earlier trial.
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Where Ravulizumab fits
Ultomiris is among the 4 FDA-approved drugs for AQP4-positive NMOSD and the longer-acting of the 2 complement C5 inhibitors. By Trial Friend's count from the labels' schedules, a new adult patient gets 8 Ultomiris infusions in the first year, against 28 for Soliris and 3 for Uplizna; Enspryng is a shot at home every 4 weeks. Its main result came from a comparison with a borrowed placebo group, and no trial has compared the 4 drugs directly.
How Ravulizumab works
In AQP4-positive NMOSD, antibodies against aquaporin-4, a water channel protein in the optic nerve, spinal cord and brain, switch on the complement system. Complement then damages those cells and causes relapses.
Ravulizumab is a lab-made antibody that binds complement protein C5 and stops it from being split, blocking the last steps of that attack. The label says the exact way it works in NMOSD is unknown but is presumed to involve blocking the complement damage that AQP4 antibodies trigger[1]. It acts on the same target as eculizumab (Soliris) but lasts longer in the body, which is why maintenance doses are 8 weeks apart instead of 2.
Side effects and safety
- Other serious infections. Higher risk of infections from Streptococcus pneumoniae, Haemophilus influenzae and gonorrhea.
- Infusion reactions. Reported in about 1% to 7% of people across trials, including back pain, belly pain, blood pressure changes and allergic reactions. Anaphylaxis has been reported after approval.
- Plasma exchange and IVIG. Plasma exchange, plasmapheresis and IV immunoglobulin lower Ultomiris levels, so an extra dose is given within 4 hours afterward.
- Meningococcal vaccination at least 2 weeks before the first dose, with boosters per ACIP
- Carry the Patient Safety Card during treatment and for 8 months after the last dose
- At least 1 hour of observation after each infusion
- Extra doses after plasma exchange, plasmapheresis or IVIG
Ultomiris carries a boxed warning for serious meningococcal infections. It raises the risk of life-threatening or fatal infections caused by Neisseria meningitidis, even in people who have been vaccinated. Meningococcal vaccines for serogroups A, C, W, Y and B must be completed or updated at least 2 weeks before the first dose, unless waiting would be riskier.
Ultomiris is available only through a restricted program called the ULTOMIRIS and SOLIRIS REMS, and patients carry a Patient Safety Card during treatment and for 8 months after the last dose[1].
In the 58-person NMOSD trial, which had no placebo group of its own, the most common side effects were COVID-19 (24%), headache (24%), back pain (12%), urinary tract infection (10%) and joint pain (10%). Fever, bladder infection and upper respiratory infection each occurred in 9%, and infusion reactions in 7%. Serious side effects were reported in 13.8% of patients[1].
The label also warns about other serious infections, including from Streptococcus pneumoniae, Haemophilus influenzae and gonorrhea, and about infusion reactions, including anaphylaxis reported after approval. Breastfeeding should stop during treatment and for 8 months after the last dose[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Ravulizumab
Ultomiris is given by IV infusion through a filter by a healthcare provider. For NMOSD, it is approved for adults who weigh at least 40 kg. A loading dose is followed 2 weeks later by the first maintenance dose, then a maintenance dose every 8 weeks[1].
Doses by body weight, loading then maintenance:
- 40 kg to under 60 kg: 2,400mg, then 3,000mg every 8 weeks
- 60 kg to under 100 kg: 2,700mg, then 3,300mg every 8 weeks
- 100 kg or more: 3,000mg, then 3,600mg every 8 weeks
The label's minimum infusion times for these doses range from 0.4 to 0.9 hours, and patients are watched for at least 1 hour afterward. A dose can occasionally move up to 7 days from the scheduled day, except the first maintenance dose. People switching from eculizumab get the loading dose when their next eculizumab dose would have been due. After plasma exchange, plasmapheresis or an IVIG course, an extra dose is given within 4 hours[1].
Availability and cost
Only available as the brand-name product.
Help paying for Ultomiris
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients may pay as little as $0 for ULTOMIRIS. Must enroll in OneSource. Not for Medicare, Medicaid or other government insurance.
For: private insurance · source - Insurance and case manager help
OneSource provides help navigating health insurance, treatment education, and a local Patient Education Manager.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: If you have Medicare, Medicaid or other government insurance, OneSource says it can connect you to third-party resources that may help. OneSource also offers vaccination support.
- From a charity · Good DaysNeuromyelitis Optica Spectrum Disorder fundOpen
Pays for: Copays for FDA-approved medications (plus travel for some funds), up to $2,100 per year. Requires health insurance (any kind).
The foundation says: “Program Status: open.” - From a charity · NORD RareCareNMOSD Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting Applications” - From a charity · NORD RareCareNMOSD Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting Applications” - From a charity · The Assistance FundNeuromyelitis Optica Spectrum Disorder (NMOSD) fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
- From a charity · TotalAssist (formerly PAN Foundation)Neuromyelitis Optica Spectrum Disorder fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $8,000 per year. Requires health insurance (any kind).
Every program and charity fund for Neuromyelitis Optica Spectrum Disorder →
Access and eligibility
Approved for adults with NMOSD who test positive for anti-aquaporin-4 (AQP4) antibodies and weigh at least 40 kg. It is not approved for AQP4-negative NMOSD, and the label says safety and effectiveness in children with NMOSD have not been established. Ultomiris cannot be started during an unresolved serious meningococcal infection.
Source: Alexion OneSource, Ultomiris financial assistance
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
CHAMPION-NMOSD (NCT04201262) treated 58 adults with AQP4-positive NMOSD who had at least 1 relapse in the prior year. It had no placebo group of its own. Instead, results were compared with the placebo group of the earlier Soliris trial, PREVENT. AstraZeneca says a new placebo group was ruled out for ethical reasons[1][4][3].
No patient on Ultomiris had a confirmed relapse during the primary treatment period, a median of 73.5 weeks. Against the borrowed placebo group, that was a 98.6% lower risk of relapse (hazard ratio 0.014). The 2 groups were not identical: 48% of the Ultomiris group took other immune treatment against 72% of the placebo group, and the placebo group had more past relapses. Results were similar with or without other treatment[1].
Development history
Alexion Pharmaceuticals developed ravulizumab as a longer-acting successor to eculizumab, first approved for paroxysmal nocturnal hemoglobinuria in December 2018. AstraZeneca acquired Alexion in 2021. The FDA approved Ultomiris for AQP4-positive NMOSD in adults on March 22, 2024[2], and AstraZeneca announced it on March 25, 2024 as the first long-acting C5 inhibitor for the disease[3]. A study of Ultomiris in children and teens with NMOSD is listed on ClinicalTrials.gov as NCT05346354[5].
Explore Neuromyelitis Optica Spectrum Disorder trials
Other Neuromyelitis Optica Spectrum Disorder treatments
AQP4-positive NMOSD has 4 FDA-approved drugs. Eculizumab (Soliris, plus biosimilars Bkemv and Epysqli) and ravulizumab (Ultomiris) block complement C5. Inebilizumab (Uplizna) removes CD19-positive B cells that make the antibodies. Satralizumab (Enspryng) blocks the interleukin-6 receptor. Rituximab, azathioprine and mycophenolate are used off label.
Common questions about Ravulizumab
▸What is Ravulizumab (Ultomiris)?
A long-acting complement C5 inhibitor approved on March 22, 2024 for adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. After a weight-based loading dose, it is an IV infusion every 8 weeks. In its main trial, no one on Ultomiris had a confirmed relapse over a median of about 73 weeks, compared with a placebo group from an earlier trial.
▸How does Ravulizumab work?
In AQP4-positive NMOSD, antibodies against aquaporin-4, a water channel protein in the optic nerve, spinal cord and brain, switch on the complement system. Complement then damages those cells and causes relapses.
Ravulizumab is a lab-made antibody that binds complement protein C5 and stops it from being split, blocking the last steps of that attack. The label says the exact way it works in NMOSD is unknown but is presumed to involve blocking the complement damage that AQP4 antibodies trigger[1]. It acts on the same target as eculizumab (Soliris) but lasts longer in the body, which is why maintenance doses are 8 weeks apart instead of 2.
▸What are the side effects of Ravulizumab?
Ultomiris carries a boxed warning for serious meningococcal infections. It raises the risk of life-threatening or fatal infections caused by Neisseria meningitidis, even in people who have been vaccinated. Meningococcal vaccines for serogroups A, C, W, Y and B must be completed or updated at least 2 weeks before the first dose, unless waiting would be riskier. Ultomiris is available only through a restricted program called the ULTOMIRIS and SOLIRIS REMS, and patients carry a Patient Safety Card during treatment and for 8 months after the last dose[1].
In the 58-person NMOSD trial, which had no placebo group of its own, the most common side effects were COVID-19 (24%), headache (24%), back pain (12%), urinary tract infection (10%) and joint pain (10%). Fever, bladder infection and upper respiratory infection each occurred in 9%, and infusion reactions in 7%. Serious side effects were reported in 13.8% of patients[1].
The label also warns about other serious infections, including from Streptococcus pneumoniae, Haemophilus influenzae and gonorrhea, and about infusion reactions, including anaphylaxis reported after approval. Breastfeeding should stop during treatment and for 8 months after the last dose[1].
▸How is Ravulizumab taken?
Ultomiris is given by IV infusion through a filter by a healthcare provider. For NMOSD, it is approved for adults who weigh at least 40 kg. A loading dose is followed 2 weeks later by the first maintenance dose, then a maintenance dose every 8 weeks[1].
Doses by body weight, loading then maintenance:
- 40 kg to under 60 kg: 2,400mg, then 3,000mg every 8 weeks
- 60 kg to under 100 kg: 2,700mg, then 3,300mg every 8 weeks
- 100 kg or more: 3,000mg, then 3,600mg every 8 weeks
The label's minimum infusion times for these doses range from 0.4 to 0.9 hours, and patients are watched for at least 1 hour afterward. A dose can occasionally move up to 7 days from the scheduled day, except the first maintenance dose. People switching from eculizumab get the loading dose when their next eculizumab dose would have been due. After plasma exchange, plasmapheresis or an IVIG course, an extra dose is given within 4 hours[1].
▸Is Ravulizumab FDA approved?
Yes, Ravulizumab (Ultomiris) is FDA approved (2024) for the treatment of Neuromyelitis Optica Spectrum Disorder.
▸How often is Ultomiris given for NMOSD?
Every 8 weeks, after a loading dose and a first maintenance dose 2 weeks later.
Dose: Based on weight, from 3,000mg to 3,600mg for maintenance in adults 40 kg and over.
Time in the chair: The label's minimum infusion times are 0.4 to 0.9 hours, plus at least 1 hour of observation.
Source: FDA label for Ultomiris, DailyMed, effective October 2025
▸Did anyone relapse on Ultomiris in the NMOSD trial?
No. None of the 58 patients had a confirmed relapse during the primary treatment period, a median of 73.5 weeks.
Comparison: Against the placebo group borrowed from the earlier Soliris trial, that was a 98.6% lower risk of relapse.
Caveat: The trial had no placebo group of its own, and the 2 groups differed in other treatment and past relapses.
Source: FDA label for Ultomiris, DailyMed; AstraZeneca, March 25, 2024
▸Can I switch from Soliris to Ultomiris for NMOSD?
Yes, the label gives a switching plan.
Timing: The Ultomiris loading dose is given when your next Soliris dose would have been due, and maintenance starts 2 weeks later.
What changes: Infusions go from every 2 weeks to every 8 weeks, and the safety card period after the last dose goes from 3 months to 8 months.
Source: FDA label for Ultomiris, DailyMed, effective October 2025
▸Can teenagers with NMOSD get Ultomiris?
Not under the current label.
What the label says: The NMOSD approval covers adults, and safety and effectiveness in children with NMOSD have not been established.
Being studied: A study in children and teens is listed on ClinicalTrials.gov as NCT05346354.
Source: FDA label for Ultomiris, DailyMed; ClinicalTrials.gov NCT05346354
▸What vaccines do I need before Ultomiris?
Meningococcal vaccines for serogroups A, C, W, Y and B, completed or updated at least 2 weeks before the first dose.
If treatment is urgent: Antibiotics are given and the vaccines follow as soon as possible.
Still at risk: Vaccines lower but do not remove the risk. Get emergency care for fever, headache with a stiff neck, a rash, confusion or eyes sensitive to light.
Safety card: Carry the Patient Safety Card during treatment and for 8 months after the last dose.
Source: FDA label for Ultomiris, DailyMed, effective October 2025
▸What are the side effects of Ultomiris for NMOSD?
The most common in the NMOSD trial were COVID-19, headache, back pain, urinary tract infection and joint pain.
Rates: COVID-19 24%, headache 24%, back pain 12%, urinary tract infection 10%, joint pain 10%.
Serious: Serious side effects were reported in 13.8% of patients.
Boxed warning: Serious meningococcal infections, which can be fatal even after vaccination.
Source: FDA label for Ultomiris, DailyMed, effective October 2025
▸Is there copay help for Ultomiris?
Yes, for people with commercial insurance.
Copay program: Alexion says eligible commercially insured patients enrolled in OneSource may pay as little as $0.
Not eligible: Medicare, Medicaid and other federal or state plans. OneSource says it can point those patients to third-party resources.
Contact: Alexion OneSource at 1-888-765-4747.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2025-10-09. ULTOMIRIS (ravulizumab-cwvz) injection, for intravenous use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a9a590d9-0217-43c7-908d-e62a71279791
- U.S. Food and Drug Administration. Drugs@FDA: ULTOMIRIS, BLA 761108, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761108
- AstraZeneca · 2024-03-25. Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD). https://www.astrazeneca.com/media-centre/press-releases/2024/ultomiris-approved-in-the-us-for-nmosd.html
- ClinicalTrials.gov. An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD. https://clinicaltrials.gov/study/NCT04201262
- ClinicalTrials.gov. Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD. https://clinicaltrials.gov/study/NCT05346354
- Alexion, AstraZeneca Rare Disease. Alexion OneSource: Ultomiris financial assistance. https://alexiononesource.com/ultomiris/financial-assistance