Your first 90 days
Your first 90 days on Ultomiris for IgA nephropathy
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 bottle to refill, because a healthcare provider gives every dose into a vein. After 2 starting infusions 2 weeks apart, the next one comes every 8 weeks, at an infusion center, an office or, for some people, at home. 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 REMS, 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 6 things in the way, in order.
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 nephrologist 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
Pneumonia and Hib vaccines, a question to ask
The label says Ultomiris may also raise the risk of other infections, including Streptococcus pneumoniae and Haemophilus influenzae.
- It says children may be at higher risk from these bacteria, and to give pneumococcal and Hib vaccines according to ACIP advice.
- The Medication Guide mentions these vaccines only for children, so ask your nephrologist whether either applies to you.FDA label
A certified prescriber, and the counseling the REMS requires
Your nephrologist 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, and they must confirm that your prescriber is certified.
- A clinic outside the program cannot give it, so the office books a site that is enrolled.FDA label
OneSource enrollment, which you sign too
You or your nephrologist's office can enroll you in Alexion OneSource online, by email or by fax at 1-800-420-5150.
- Signing the form lets OneSource share the health information it needs to help you.
- 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 it, the second infusion on day 15 and one infusion every 8 weeks after that. 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 nephrologist's office or you send the signed OneSource enrollment form.
- OneSource explains what your plan covers and can tell you about infusion centers near you.
- 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 nephrologist 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.
- Alexion lists infusion centers, doctors' offices and home infusion for those who are eligible.
First infusion, the starting dose
The starting dose is 2,400mg, 2,700mg or 3,000mg depending on your weight.
- The label's shortest allowed infusion time runs from about 24 to 48 minutes by weight.
- Staff watch you for at least 1 hour after it ends.
- 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 of 3,000mg, 3,300mg or 3,600mg by weight.
- The label says this one should not move, while later infusions may shift by up to 7 days.
An infusion every 8 weeks from here
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.
Three months in
AstraZeneca reported on October 21, 2026 that, in an interim analysis of the I CAN trial, urine protein fell 46.6% by week 34.
- On placebo it fell 5.6%, and the drop on Ultomiris was already seen by week 10.
- Your nephrologist keeps measuring urine protein to see how you respond.
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.
Label dated October 21, 2026, read on DailyMed. FDA label
- October 2026
Accelerated approval for IgA nephropathy, to reduce protein in the urine in adults at risk of progression. The label's dosing table added IgAN for adults weighing 40kg (about 88 pounds) or more. The REMS brochure, Patient Guide and website were updated the same day.FDA letter
- June 2026
The REMS added checkboxes to the enrollment form for infusion sites and pharmacies and updated its website. The FDA letter lists no change to what patients must do.FDA letter
- March 2024
NMOSD was added as a use, and the Ultomiris REMS was combined with the Soliris REMS into the ULTOMIRIS and SOLIRIS REMS. Its materials were also updated to match a February 2024 safety labeling change.FDA letter
- December 2018
The FDA first approved the Ultomiris REMS on December 21, 2018. The Soliris REMS, which Ultomiris later joined, dates back to June 4, 2010.FDA 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
Alexion says Ultomiris is given through an IV infusion once every 8 weeks, with doses based on weight.
- A healthcare provider gives it at an infusion center or doctor's office, or at home for those who are eligible.Ultomiris IgAN site
- The dose follows your weight
For IgA nephropathy the label covers adults weighing 40kg (about 88 pounds) or more.
- From 40kg to under 60kg (88 to 132 pounds), the doses are 2,400mg, then 3,000mg.
- From 60kg to under 100kg (132 to 220 pounds), they are 2,700mg, then 3,300mg.
- At 100kg (220 pounds) or more, they are 3,000mg, then 3,600mg.FDA label
- If you miss an infusion
The Medication Guide says to call your healthcare provider right away.
- The label lets an infusion move up to 7 days from its planned day, except the first regular dose.
- After a shifted infusion, later doses go back to the original schedule.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 on the list 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
- 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
- Other treatments that change the dose
Plasma exchange, plasmapheresis and IVIG lower Ultomiris levels, and the label calls for an extra dose after each.
- Drugs called FcRn blockers, such as efgartigimod, may make Ultomiris work less well.
- Tell your nephrologist about any of these before they start.FDA label
- Pregnancy and breastfeeding
The label says there are no data on Ultomiris in pregnancy, and that untreated IgA nephropathy carries its own risks in 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 some 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.Medication Guide
- Storage, if you get it at home
The label says the vials stay in the refrigerator at 36 to 46 degrees Fahrenheit, in their carton to protect them from light, and are never frozen or shaken.
- The vials come as 300mg and 1,100mg, one per carton.openFDA 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 signs may quickly become life-threatening or cause death.
- 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 or a swollen face, tongue or throat are more serious.
- The Medication Guide says the infusion stops and your provider is told right away.Medication Guide
Common side effects in the IgAN trial
In the I CAN trial, upper respiratory infections occurred in 11% on Ultomiris against 10% on placebo.
- Infusion reactions were 8% against 5%, and headache 7% against 5%.
- Serious side effects were reported in 4.6% on Ultomiris and 9.0% on placebo.FDA label
Other infections
The label says Ultomiris also raises 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.
- Your vaccine dates are missingThe prescriber must check your meningococcal vaccines before the first dose, and certified sites collect vaccination status for the REMS. The fix is the office sending the vaccine dates, or the antibiotic prescription if treatment cannot wait.FDA letter
- 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 rather than a denial.FDA label
- Your plan's policy does not list IgA nephropathy yetThe FEP policy below was written before the October 2026 approval and says Ultomiris may be considered investigational for all other indications. Alexion Access Navigator posts an IgAN letter of medical necessity and a sample appeal letter for your nephrologist's office.Alexion Access Navigator
- A copay you cannot payWith commercial insurance, the OneSource CoPay Program can bring the cost as low as $0, and annual maximums may apply. 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. The infusion site can tell you its fee before the first visit.CoPay terms
- The vaccines themselves cost moneyOneSource says it can help you find a vaccination site and share resources that may cover vaccine costs. You need to be enrolled and have the vaccines prescribed.OneSource vaccines
Blue Cross Blue Shield Federal Employee Program prior authorization policy, July 1, 2026
- Covered uses listed are PNH, aHUS, generalized myasthenia gravis and NMOSD; IgA nephropathy is not listed
- Ultomiris may be considered investigational for all other indications, in the policy's words
- 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.
This policy was approved on June 11, 2026 and cites the September 2025 label, so it predates the October 2026 approval for IgA nephropathy. Under it, an IgAN request falls under other uses until a newer version adds it. 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.
- A support specialist who explains your insurance coverage, helps with gaps in coverage and points you to infusion centers nearby
- Vaccination support for enrolled patients, including help finding a vaccination site and resources that may cover vaccine costs
- The Alexion OneSource CoPay Program for commercial insurance, as little as $0 for Ultomiris and eligible infusion costs, and annual maximums may apply
- 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
- Enrollment online, by email to OneSource@Alexion.com or by fax at 1-800-420-5150, with interpreters available
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?
- Do I also need a pneumonia shot or a Hib shot?
- 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 every 8 weeks, and who do I call if one has to move?
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 nephrologist starts antibiotics instead. 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 says to give pneumococcal and Hib vaccines per ACIP advice, and the Medication Guide mentions them only for children, so ask your nephrologist.
How often is Ultomiris given for IgA nephropathy?
After a starting dose, the second infusion comes 2 weeks later, then one every 8 weeks. Each dose depends on your weight, and the IgAN dosing covers adults weighing at least 40kg (about 88 pounds).
What if I miss an Ultomiris infusion?
The Medication Guide says to call your healthcare provider right away. The label allows an infusion to move up to 7 days from its 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.
Does Ultomiris slow kidney damage in IgA nephropathy?
That has not been established yet, according to the label. The FDA granted accelerated approval on October 21, 2026, based on lower protein in the urine. AstraZeneca says the I CAN trial continues and will measure kidney function (eGFR) at week 106.
Why was Ultomiris denied by my insurance?
Some plan policies, such as the FEP policy on this page, were written before the October 2026 approval and do not list IgA nephropathy yet. That policy says Ultomiris may be considered investigational for all other indications. Your nephrologist's office can ask for an exception or appeal, and Alexion posts sample letters for that.
Does Ultomiris need regular blood tests?
The label sets no scheduled blood test for IgA nephropathy. Your nephrologist keeps tracking protein in the urine and kidney function to see whether it is working.
Can I get Ultomiris at home?
Alexion says home infusion is an option for those who are eligible, along with infusion centers and doctors' offices. A healthcare provider still gives every dose, and the site must be certified in the REMS.
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Sources
- ULTOMIRIS (ravulizumab-cwvz) injection, for intravenous use, prescribing information and Medication Guide, revised October 2026 (BLA 761108/S-046), Alexion Pharmaceuticals, via FDA, October 21, 2026.
- MEDICATION GUIDE, ULTOMIRIS (ravulizumab-cwvz) injection, for intravenous use, revised 10/2026, Alexion Pharmaceuticals, October 21, 2026.
- ULTOMIRIS (ravulizumab-cwvz) label, SPL version 19, section 16 How Supplied/Storage and Handling, Alexion Pharmaceuticals, via openFDA, October 9, 2025.
- IgAN Treatment Patient Website | ULTOMIRIS® (ravulizumab-cwvz), Alexion Pharmaceuticals, November 9, 2026.
- IgA Nephropathy Treatment | ULTOMIRIS® (ravulizumab-cwvz), Alexion Pharmaceuticals, November 9, 2026.
- Alexion OneSource™ | ULTOMIRIS | Financial Assistance, Alexion Pharmaceuticals, November 9, 2026.
- Alexion OneSource™ | ULTOMIRIS | About OneSource™, Alexion Pharmaceuticals, November 9, 2026.
- Alexion OneSource™ | ULTOMIRIS | Fill Out a Start Form, Alexion Pharmaceuticals, November 9, 2026.
- Alexion OneSource™ | ULTOMIRIS | Vaccination-Support, Alexion Pharmaceuticals, November 9, 2026.
- Alexion OneSource™ CoPay Program Terms and Conditions, US/ALL/1223 V1 12/2024, Alexion Pharmaceuticals, November 9, 2026.
- Alexion Access Navigator | Ultomiris IgAN, Alexion Pharmaceuticals, November 9, 2026.
- 5.85.033 Ultomiris (ravulizumab-cwvz), Blue Cross Blue Shield Federal Employee Program, July 1, 2026.
- Ultomiris received accelerated approval in the US as first and only C5 complement inhibitor to reduce proteinuria in adults with primary immunoglobulin A nephropathy, AstraZeneca, October 21, 2026.
- BLA 761108/S-046 and BLA 125166/S-455 accelerated approval letter, IgA nephropathy and REMS modification, FDA, October 21, 2026.
- BLA 761108/S-045 and BLA 125166/S-453 supplement approval letter, REMS modification, FDA, June 1, 2026.
- BLA 761108/S-026 and S-031 supplement approval letter, NMOSD and the combined Ultomiris and Soliris REMS, FDA, March 22, 2024.
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 nephrologist. Found an error? Use the report link in the footer and it will be checked against the source.