Your first 90 days
Your first 90 days on Ultomiris for PNH
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Ultomiris has no box to refill, because a healthcare provider gives every dose into a vein. After a starting infusion and a second one 2 weeks later, infusions come every 8 weeks at 20kg or more. Before the first one, the label requires meningitis vaccines at least 2 weeks ahead, and its boxed warning explains why. This page lays out those first 3 months from the FDA label, the FDA's REMS page, Alexion's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Ultomiris is given under a REMS, so the first infusion waits on meningococcal vaccines, a certified prescriber, a certified infusion site and an insurance approval. These are the 9 things in the way, in order.
A PNH diagnosis, at any age from 1 month
The label approves Ultomiris for adults and children 1 month of age and older with PNH.
- Its dosing table starts at a body weight of 5kg (about 11 pounds).
- The Medication Guide says it is not known if Ultomiris is safe and effective in children younger than 1 month.FDA label
Meningococcal vaccines, at least 2 weeks before the first dose
Ultomiris blocks a complement protein called C5, and the label says this raises the risk of serious meningococcal infection.
- The label requires vaccines against Neisseria meningitidis serogroups A, C, W, Y and B at least 2 weeks before the first dose.
- In plain terms, those are the MenACWY and MenB shots.
- The schedule follows ACIP advice for people on a complement inhibitor, which differs from the usual one.
- Shots you had in the past may not be enough, and your hematologist decides what you need.FDA label
Or antibiotics, if treatment cannot wait
If Ultomiris has to start before your vaccines are up to date, the label says to give antibiotics and the vaccines as soon as possible.
- The REMS requires the prescriber to write that antibiotic prescription.
- The Medication Guide says the antibiotics continue for as long as your healthcare provider tells you.FDA label
For children, pneumonia and Hib vaccines too
The label says children treated with Ultomiris may be at higher risk of serious infections from Streptococcus pneumoniae and Haemophilus influenzae type b (Hib).
- It says to give vaccines against both according to ACIP advice.
- The Medication Guide tells parents that a child treated with Ultomiris should receive these vaccines.FDA label
No serious meningococcal infection at the start
The label says Ultomiris must not be started in anyone with a serious meningococcal infection that has not cleared.
- The Medication Guide also asks you to tell your healthcare provider if you have an infection or fever.FDA label
A certified prescriber, and the counseling the REMS requires
Your hematologist must be enrolled in the ULTOMIRIS and SOLIRIS REMS, the same program Soliris uses.
- The REMS requires counseling on meningococcal infection, written materials, a check of your vaccines and a Patient Safety Card.
- The label lists the REMS line as 1-888-765-4747, the same number as OneSource.FDA label
A certified place to get the infusion
Only healthcare settings and pharmacies certified in the REMS may dispense Ultomiris.
- Before the first dose, the site must confirm that your prescriber is certified and record your meningococcal vaccine status.
- A clinic outside the program cannot give it, so the office books a site that is enrolled.FDA REMS page
Your other treatments and health history
The Medication Guide asks you to tell your healthcare provider about every medicine and vaccine, any infection or fever, and any pregnancy or breastfeeding plans.
- If you take Soliris now, the label times the first Ultomiris dose to your next scheduled Soliris dose.
- The label also says Ultomiris treatment should not change how blood thinners are managed.FDA label
OneSource enrollment, which you sign too
You or your hematologist's office can enroll you in Alexion OneSource online, by email or by fax at 1-800-420-5150.
- The online form is for a patient or a legal representative, such as a parent, and signing it lets OneSource share required health information.
- You do not have to enroll just to ask questions, and interpreters are available.OneSource enrollment
The days that matter
Counted from the first infusion, with the vaccine deadline 2 weeks before, the second infusion on day 15 and then one every 8 weeks, or every 4 weeks under 20kg. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.OneSource enrollment and the insurance check
Your hematologist's office or you send the signed OneSource enrollment form, and the office asks your plan for approval.
- No public source sets how long the insurance review usually takes.
Vaccines done, or scheduled
The MenACWY and MenB shots need at least 2 weeks before day 1 to count.
- Ask your hematologist which doses are due now and which, if any, come later.
Last day for the vaccines to count
Shots given after this point fall inside the 2-week window.
- If treatment cannot wait, the label says antibiotics are added and the vaccines are given as soon as possible.
Approval, then booking a certified site
Once the plan approves, the office books the first 2 infusions, 2 weeks apart, at a site certified in the REMS.
- The site checks your prescriber's certification and your vaccine record before the first dose.
First infusion, the starting dose
The starting dose runs from 600mg to 3,000mg, depending on body weight.
- The label's shortest allowed infusion time for it runs from about 24 to 84 minutes by weight.
- Staff watch for a reaction for at least 1 hour after it ends.
- For anyone switching from Soliris, the label places this dose when the next Soliris dose was due.
- Put the Patient Safety Card in your wallet the same day.
Second infusion, the first regular dose
Two weeks after the starting dose comes the first maintenance dose, from 300mg to 3,600mg by weight.
- The label says this one should not move, while later infusions may occasionally shift by up to 7 days.
Under 20kg, an infusion every 4 weeks
For children weighing 5kg to under 20kg (about 11 to 44 pounds), the label sets a maintenance infusion every 4 weeks.
- These are counted from day 15.
- The label's dosing tables use body weight at the time of treatment, so the dose and schedule can change as a child grows.
Under 20kg, number 2
At 20kg or more, an infusion every 8 weeks
For anyone weighing 20kg (about 44 pounds) or more, each maintenance infusion comes 8 weeks after the one before, counted from day 15.
- If one is missed, the Medication Guide says to call your healthcare provider right away.
If Ultomiris is stopped
Close monitoring for at least 16 weeks
The label says stopping Ultomiris can bring back red blood cell breakdown from PNH.
- It calls for close monitoring for at least 16 weeks after stopping.
- The label lists a rise in LDH with a sudden drop in hemoglobin or PNH clone size, or symptoms coming back, as the signs.
- Any decision about stopping belongs to your hematologist.
Three months in
In the label's trial of 246 adults new to this type of medicine, 73.6% on Ultomiris avoided a transfusion over 26 weeks.
- The figure for eculizumab (Soliris) was 66.1%.
- LDH, a blood marker of red blood cell breakdown, returned to normal in 53.6% on Ultomiris and 49.4% on eculizumab.
- The trial was built to show Ultomiris was not worse than eculizumab, and it did.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Ultomiris label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated October 29, 2026, read from the FDA's label database today. FDA label
- October 2026
The label added IgA nephropathy as a fifth use. Its list of recent changes names only that use and the dosing section that now includes it.FDA label
- June 2026
The REMS added checkboxes to the enrollment form for infusion sites and pharmacies and updated its website. The FDA's summary lists no change to what patients must do.FDA REMS page
- June 2024
The FDA approved removing the under-the-skin route, given with an on-body delivery system, from the prescribing information and Medication Guide on June 28, 2024.FDA letter, June 2024
- March 2024
The Ultomiris REMS and the Soliris REMS were merged into a single program on March 22, 2024, now called the ULTOMIRIS and SOLIRIS REMS.FDA REMS page
- July 2022
The FDA approved an under-the-skin form of Ultomiris, with an on-body delivery system, for adults with PNH and aHUS on July 22, 2022. The October 2026 label describes only infusion into a vein.FDA letter, July 2022
- June 2021
The FDA extended the PNH approval to children on June 7, 2021. The current label sets the youngest age at 1 month.FDA letter, children
- December 2018
The FDA first approved Ultomiris on December 21, 2018, for adults with PNH, and approved its REMS the same day.FDA approval letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Given by a healthcare provider, into a vein
The Medication Guide says a healthcare provider gives Ultomiris through a needle placed in a vein.
- The current label says Ultomiris is intended only for infusion into a vein.
- Each infusion runs through a filter, and the label calls for watching for a reaction for at least 1 hour afterward.FDA label
- The dose follows weight, at 40kg or more
From 40kg to under 60kg (88 to 132 pounds), the doses are 2,400mg, then 3,000mg every 8 weeks.
- From 60kg to under 100kg (132 to 220 pounds), they are 2,700mg, then 3,300mg every 8 weeks.
- At 100kg (220 pounds) or more, they are 3,000mg, then 3,600mg every 8 weeks.FDA label
- The dose follows weight, under 40kg
From 5kg to under 10kg (11 to 22 pounds), the doses are 600mg, then 300mg every 4 weeks.
- From 10kg to under 20kg (22 to 44 pounds), they are 600mg, then 600mg every 4 weeks.
- From 20kg to under 30kg (44 to 66 pounds), they are 900mg, then 2,100mg every 8 weeks.
- From 30kg to under 40kg (66 to 88 pounds), they are 1,200mg, then 2,700mg every 8 weeks.FDA label
- How long each infusion takes
The label sets a shortest allowed infusion time for each dose and weight group.
- For starting doses, that runs from about 24 minutes in the heaviest group to about 84 minutes in the lightest.
- For regular doses, it runs from about 30 minutes to about 78 minutes.
- The hour of watching afterward comes on top of that.FDA label
- If you miss an infusion
The Medication Guide says to call your healthcare provider right away.
- The label lets the schedule occasionally vary within 7 days of the planned day, except the first regular dose.
- After a shifted infusion, later doses go back to the original schedule.FDA label
- If you are switching from Soliris
The label says the Ultomiris starting dose is given at the time of your next scheduled Soliris (eculizumab) dose.
- The first regular Ultomiris dose follows 2 weeks later.
- The label's switching trial enrolled 195 adults who had been stable on eculizumab for at least 6 months.
- Over 26 weeks, 87.6% of those who switched avoided a transfusion, against 82.7% of those who stayed on eculizumab.FDA label
- Fever is a call, not a wait
The Medication Guide lists fever, fever with a high heart rate, headache with fever, confusion and flu-like muscle aches as warning signs.
- Fever with a rash, headache with nausea or vomiting, headache with a stiff neck or back, and eyes sensitive to light are listed too.
- It says to call your provider or get emergency care right away.FDA label
- The card outlasts the drug
The label requires carrying the Patient Safety Card at all times during treatment and for 8 months after the last dose.
- The Medication Guide says the infection risk may continue for several months after stopping.
- Show the card to any healthcare provider who treats you, so they can act quickly.FDA label
- Stopping has its own watch period
The Medication Guide says anyone with PNH who stops Ultomiris is monitored closely for at least 16 weeks.
- It lists a drop in red blood cell count, tiredness, blood in the urine, stomach-area pain, shortness of breath, blood clots, trouble swallowing and erectile dysfunction as signs.
- If signs of red blood cell breakdown appear, the label tells the prescriber to consider restarting Ultomiris.
- Any change to treatment is a decision for your hematologist.FDA label
- Boosters
The label says to revaccinate according to ACIP advice, considering how long treatment lasts.
- Vaccines lower the risk but do not remove it, and the label says serious infections have occurred in vaccinated patients too.FDA label
- Blood thinners
The label says the effect of stopping blood thinners during Ultomiris treatment has not been established.
- For that reason, it says Ultomiris treatment should not change how blood thinners are managed.
- Your hematologist decides what is right for you.FDA label
- Plasma exchange, IVIG and FcRn blockers
Plasma exchange, plasmapheresis and IVIG lower Ultomiris levels, and the label calls for an extra dose within 4 hours after each session or IVIG cycle.
- Its table of extra doses covers people weighing 40kg (about 88 pounds) or more.
- Drugs called FcRn blockers, such as efgartigimod, may make Ultomiris work less well.
- Tell your hematologist about any of these before they start.FDA label
- How long treatment lasts
The Medication Guide says your healthcare provider will decide how long you need to receive Ultomiris.
- The label sets no end date for PNH treatment.
- The Safety Card stays with you for 8 months after the last dose.FDA label
- Pregnancy and breastfeeding
The label says there are no data on Ultomiris in pregnant women, and it is not known whether it harms an unborn baby.
- It also says PNH itself carries risks for the mother and baby during pregnancy.
- A pregnancy registry for Ultomiris takes calls at 1-833-793-0563 for anyone who becomes pregnant.
- The Medication Guide says not to breastfeed during treatment and for 8 months after the final dose.FDA label
- Gonorrhea risk
The Medication Guide says certain people on Ultomiris may be at risk of serious gonorrhea infections.
- It suggests talking with your healthcare provider about your risk, prevention and regular testing.FDA label
- Driving
The label and Medication Guide carry no caution about driving or using machines.
- Dizziness was reported in 5% of the 222 adults who got Ultomiris in the PNH trials.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs the label ties to meningococcal infection
Fever, fever with a high heart rate, headache and fever, confusion, or flu-like muscle aches.
- Fever and a rash, headache with nausea or vomiting, headache with a stiff neck or back, or eyes sensitive to light count too.
- The Medication Guide says these infections may quickly become life-threatening or cause death if not treated early.
- Call your provider or get emergency care right away, card in hand.FDA label
A reaction during the infusion
Lower back or stomach pain, muscle spasms, changes in blood pressure, tiredness, feeling faint, shaking chills, discomfort in the arms or legs, or a bad taste.
- Chest pain, trouble breathing, a swollen face, tongue or throat, or passing out are more serious.
- The Medication Guide says the infusion stops and your provider is told right away.FDA label
Signs of red blood cell breakdown after stopping
A drop in red blood cell count, tiredness, blood in the urine, stomach-area pain, shortness of breath, blood clots, trouble swallowing or erectile dysfunction.
- The Medication Guide ties these to stopping Ultomiris, and the label calls for close monitoring for at least 16 weeks.
- Tell your hematologist about any of them.FDA label
Common side effects in the adult PNH trials
Among 222 adults on Ultomiris, upper respiratory tract infection was reported in 39%, the same rate as on eculizumab.
- Headache was reported in 32%, against 26% on eculizumab.
- Diarrhea and nausea were each reported in 9%, and fever in 7%.
- Serious side effects were reported in 6.8%, and the label records 1 death from sepsis.
- Infusion reactions were reported in 1%.FDA label
Side effects in the children's trial
The label's PNH trial in children treated 13 patients aged 9 to 17.
- Upper respiratory tract infection was reported in 7 of them (54%).
- Anemia, stomach-area pain and headache were each reported in 3 (23%).
- The label says safety in children appeared similar to safety in adults.FDA label
Other infections
The label says Ultomiris may also raise the risk of infections from Streptococcus pneumoniae, Haemophilus influenzae and, to a lesser extent, gonorrhea bacteria.
- It asks patients to report any new sign of infection to their care team.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- Prior authorization pending or deniedThe FEP policy below asks for age 1 month or older and a baseline LDH value on record. It also asks that no other PNH drug on its prior authorization list is used at the same time. That list names Soliris, Fabhalta, Empaveli and Ultomiris. Your hematologist's office sends the records that show each of these points.FEP Blue policy
- Your vaccine dates are missingThe REMS requires the infusion site or pharmacy to check and record your meningococcal vaccine status before the first dose. The fix is the office sending the vaccine dates, or the antibiotic prescription if treatment cannot wait.FDA REMS page
- The infusion site is not certifiedOnly healthcare settings and pharmacies certified in the ULTOMIRIS and SOLIRIS REMS may dispense it. The office moves the booking to a certified site, which makes it a routing problem and not a denial.FDA REMS page
- The prescriber is not enrolled in the REMSBefore each dispense, the site must contact the REMS to confirm the prescriber is certified. A prescriber enrolls by completing the Prescriber Enrollment Form and sending it to the REMS.FDA REMS page
- The plan says no after reviewAlexion Access Navigator posts a PNH sample letter of medical necessity and a PNH sample appeal letter for your hematologist's office. It also posts a guide to peer-to-peer reviews, which it describes as a step before a formal appeal.Alexion Access Navigator
- A copay you cannot payWith commercial insurance, the OneSource CoPay Program can bring the cost as low as $0 for eligible patients. Medicare, Medicaid and other government plans are excluded, and OneSource says it can connect those patients with third-party resources.OneSource
- You live in Massachusetts or Rhode IslandThe CoPay terms say residents of these 2 states can get help with medicine costs but not with infusion costs. OneSource answers questions about the terms at 1-888-765-4747.CoPay terms
- The renewal after 6 monthsThe FEP policy approves 6 months at first, then 12 months at a time. Renewal asks for a serum LDH that has fallen from the level before treatment, and no unacceptable toxicity. Ask the office when the renewal is due.FEP Blue policy
Blue Cross Blue Shield Federal Employee Program prior authorization policy, July 1, 2026
- Paroxysmal nocturnal hemoglobinuria, age 1 month or older
- A documented baseline value for serum lactate dehydrogenase (LDH)
- No dual therapy with another prior authorization medication for PNH; the policy's list names Soliris, Fabhalta, Empaveli and Ultomiris
- Vaccinated against Neisseria meningitidis at least 2 weeks before starting, unless treatment cannot be delayed
- The prescriber is enrolled in the REMS program
Approval length. Six months at first, then 12 months at a time on renewal. Renewal asks for a decrease in serum LDH from the pretreatment baseline, no unacceptable toxicity and continued REMS enrollment.
This policy was approved on June 11, 2026 and cites the September 2025 label. It predates the October 2026 label, which added IgA nephropathy as a use. The PNH use it describes matches the current label. It still uses the old program name, Ultomiris REMS, from before March 2024. It is here as an example of what a plan asks for, not as a rule. FEP Blue policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- The Alexion OneSource CoPay Program for commercial insurance, as little as $0 for Ultomiris for eligible patients
- The CoPay Program covers eligible out-of-pocket medicine and infusion costs, and annual maximums may apply CoPay terms
- CoPay help is not open to Medicare, Medicaid or other federal- or state-funded plans, and OneSource can point those patients to third-party resources
- Residents of Massachusetts and Rhode Island can get help with medicine costs but not infusion costs, under the CoPay terms CoPay terms
- Vaccination support for enrolled patients, including help locating a vaccination site and information on resources that may cover vaccine costs OneSource vaccination support
- Help understanding insurance coverage, and information on infusion centers or other treatment locations nearby About OneSource
- Enrollment online, by email to OneSource@Alexion.com or by fax at 1-800-420-5150, with interpreters available OneSource enrollment
- Questions answered by phone without enrolling OneSource enrollment
- For the hematologist's office, a Field Reimbursement Manager plus PNH sample letters for medical necessity and appeals Alexion Access Navigator
Details as the drugmaker publishes them. OneSource
Five questions for the pharmacist or the support line
- Is my infusion site certified in the ULTOMIRIS and SOLIRIS REMS, and does it have my vaccine dates?
- Which MenACWY and MenB doses do I still need, and when is my next booster due?
- Does my child also need a pneumonia shot or a Hib shot before starting?
- Which weight group sets the dose, and when is weight checked again for a growing child?
- How long should I plan to stay, counting the infusion and the hour of watching afterward?
- Has my copay program been applied to both the medicine and the infusion fee?
- Who books my infusions, and who do I call if one has to move?
- If I am switching from Soliris, which date is my first Ultomiris infusion?
Questions people ask in the first weeks
How long does it take to start Ultomiris after it is prescribed?
The vaccines set the floor, at least 2 weeks between the meningococcal shots and the first infusion, unless the hematologist starts antibiotics too. Insurance approval and booking a certified infusion site run alongside. No public source sets a typical number of days for the whole process.
Which vaccines do I need before Ultomiris?
By the label, vaccines against Neisseria meningitidis serogroups A, C, W, Y and B, at least 2 weeks before the first dose. In plain terms, that is the MenACWY shot and the MenB shot. Earlier shots may not count, because the schedule for complement inhibitors differs from the usual one. The label also calls for pneumococcal and Hib vaccines for children, following ACIP advice.
How often is Ultomiris given for PNH?
After a starting dose, the second infusion comes 2 weeks later. From there, the label sets an infusion every 8 weeks for anyone weighing 20kg (about 44 pounds) or more. Children from 5kg to under 20kg (about 11 to 44 pounds) get one every 4 weeks.
Can children get Ultomiris for PNH?
Yes. The label covers children with PNH from 1 month of age, with doses set by weight from 5kg (about 11 pounds). Its trial in children treated 13 patients aged 9 to 17. The label says use in children under 9 and under 30kg rests on drug-level, efficacy and safety data carried over from aHUS and PNH studies.
What if I miss an Ultomiris infusion?
The Medication Guide says to call your healthcare provider right away. The label allows the schedule to occasionally vary within 7 days of the planned day, except the first regular dose on day 15.
What is the Patient Safety Card?
A card from your prescriber about the risk of serious meningococcal infection, to show any healthcare provider who treats you. The label requires carrying it at all times during treatment and for 8 months after the last dose.
Can I switch from Soliris to Ultomiris?
The label gives a plan for it, and your hematologist decides whether it fits you. The Ultomiris starting dose is given when your next Soliris dose would have been due. The first regular dose follows 2 weeks later. In the label's trial of 195 adults stable on eculizumab, none of those who switched had breakthrough hemolysis over 26 weeks, against 5.1% of those who stayed.
What happens if Ultomiris is stopped?
The label says red blood cell breakdown from PNH can return. It calls for close monitoring for at least 16 weeks after stopping. The Patient Safety Card stays with you for 8 months after the last dose. Whether to stop, pause or restart is a decision for your hematologist.
Does Ultomiris need regular blood tests for PNH?
The label sets no fixed schedule of blood tests during PNH treatment. It names LDH, hemoglobin and PNH clone size as the measures to watch for at least 16 weeks after stopping. Your hematologist decides which tests you need and how often.
Is Ultomiris given as a shot under the skin?
Not under the current label. The October 2026 label says Ultomiris is intended only for infusion into a vein, given by a healthcare provider. The FDA approved an under-the-skin version for adults in July 2022 and approved its removal from the label in June 2024.
Is Ultomiris used for other conditions?
Yes. The label also covers atypical hemolytic uremic syndrome, generalized myasthenia gravis, NMOSD and IgA nephropathy. This page covers only the PNH use of Ultomiris.
Free email alert
Hear when the Ultomiris label changes
One email the day the FDA revises the Ultomiris label, with what changed in plain words. No trial alerts, no newsletter.
Label changes for Ultomiris only, usually a few a year and some years none. Stop anytime. We never share your email. Privacy policy
Want the whole condition instead? Follow Paroxysmal nocturnal hemoglobinuria (PNH) for new trials, FDA decisions and label changes for every treatment.
Sources
- ULTOMIRIS (ravulizumab-cwvz) injection, for intravenous use: prescribing information and Medication Guide, revised 10/2026, SPL version 20, effective October 29, 2026 (openFDA record for DailyMed set ID a9a590d9-0217-43c7-908d-e62a71279791), Alexion Pharmaceuticals, via FDA openFDA, October 29, 2026.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Ultomiris and Soliris, BLA 125166 and BLA 761108, REMS last update 06/01/2026, FDA, June 1, 2026.
- Alexion OneSource™ | ULTOMIRIS | Financial Assistance, Alexion Pharmaceuticals, November 13, 2026.
- Alexion OneSource™ | ULTOMIRIS | Fill Out a Start Form, Alexion Pharmaceuticals, November 13, 2026.
- Alexion OneSource™ | ULTOMIRIS | Vaccination-Support, Alexion Pharmaceuticals, November 13, 2026.
- Alexion OneSource™ | ULTOMIRIS | About OneSource™, Alexion Pharmaceuticals, November 13, 2026.
- Alexion OneSource™ CoPay Program Terms and Conditions, US/ALL/1223 V1 12/2024, Alexion Pharmaceuticals, November 13, 2026.
- Alexion Access Navigator | Ultomiris PNH, Alexion Pharmaceuticals, November 13, 2026.
- 5.85.033 Ultomiris (ravulizumab-cwvz), Blue Cross Blue Shield Federal Employee Program, July 1, 2026.
- BLA 761108 BLA approval letter, ULTOMIRIS (ravulizumab-cwvz) for adult patients with paroxysmal nocturnal hemoglobinuria, and its REMS, FDA, December 21, 2018.
- BLA 761108/S-012 supplement approval letter, treatment of pediatric patients with paroxysmal nocturnal hemoglobinuria, FDA, June 7, 2021.
- BLA 761108/S-021 corrected supplement approval letter, subcutaneous route of administration and on-body delivery system for adults with PNH and aHUS, FDA, July 22, 2022.
- BLA 761108/S-036 supplement approval letter, removing the subcutaneous route of administration using the on-body delivery system from the Prescribing Information and Medication Guide, FDA, June 28, 2024.
- ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) (NCT02946463, Study ALXN1210-PNH-301), ClinicalTrials.gov, November 13, 2026.
- ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab (NCT03056040, Study ALXN1210-PNH-302), ClinicalTrials.gov, November 13, 2026.
- A Study of Ravulizumab (ALXN1210) in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (NCT03406507, Study ALXN1210-PNH-304), ClinicalTrials.gov, November 13, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing hematologist. Found an error? Use the report link in the footer and it will be checked against the source.