Your first 90 days
Your first 90 days on Ultomiris for generalized myasthenia gravis
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 2 starting infusions 2 weeks apart, the next one comes every 8 weeks. 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 8 things in the way, in order.
A blood test showing AChR antibodies
The label approves Ultomiris for generalized myasthenia gravis only in adults who are anti-acetylcholine receptor (AChR) antibody positive.
- The Medication Guide says it is not known if Ultomiris is safe and effective for gMG in children.
- The FEP policy shown further down this page asks for a positive AChR antibody test as well.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 neurologist 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
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 neurologist 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.
- The label says plasma exchange and IVIG lower Ultomiris levels, and that FcRn blockers such as efgartigimod may make it work less well.
- Your neurologist needs to know about those too.FDA label
OneSource enrollment, which you sign too
You or your neurologist'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, the second infusion on day 15 and one every 8 weeks after. 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 neurologist'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 neurologist 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 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's 7-day scheduling allowance does not cover this infusion, though it does cover later ones.
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.
After plasma exchange or IVIG
An extra dose within 4 hours
The label says plasma exchange, plasmapheresis and IVIG lower Ultomiris levels in the blood.
- It calls for an extra dose within 4 hours after each plasma exchange session, or after an IVIG cycle ends.
Three months in
The label's gMG trial measured its results at week 26, about 3 months past this point.
- Scores on a daily activities scale called MG-ADL improved by 3.1 points on Ultomiris and 1.4 points on placebo.
- The trial included 175 adults, who were allowed to keep taking their other myasthenia gravis medicines.
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
- March 2024
The Ultomiris REMS and the Soliris REMS merged into a single program on March 22, 2024, now called the ULTOMIRIS and SOLIRIS REMS.FDA REMS page
- April 2022
The FDA approved Ultomiris for adults with generalized myasthenia gravis who are AChR antibody positive on April 27, 2022. The same letter updated the REMS safety brochure for this use and required a study in ages 12 to 17.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 REMS page
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 label says each infusion runs through a filter, and staff watch you for at least 1 hour afterward.FDA label
- The dose follows your weight
For gMG 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
- How long each infusion takes
The label sets a shortest allowed infusion time for each dose and weight group.
- For starting doses that is about 48, 36 or 24 minutes, from the lightest weight group to the heaviest.
- For regular doses it is about 54, 42 or 30 minutes.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, then one every 8 weeks.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
- Boosters
The label says to revaccinate according to ACIP advice, considering how long treatment lasts.
- Vaccines do not remove the risk, and the label says serious infections have occurred in vaccinated patients too.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.
- Drugs called FcRn blockers, such as efgartigimod, may make Ultomiris work less well.
- Tell your neurologist about any of these before they start.FDA label
- Your other myasthenia gravis medicines
The label's trial let patients keep taking the gMG medicines they were already on.
- At the start, over 80% took an acetylcholinesterase inhibitor, 70% took corticosteroids and 68% took another immune-suppressing medicine.
- Your neurologist decides what you keep taking alongside Ultomiris.FDA label
- How long treatment lasts
The Medication Guide says your healthcare provider will decide how long you need to receive Ultomiris.
- The label's rules for monitoring after stopping are written for 2 blood conditions, PNH and aHUS, and none is written for gMG.
- The Safety Card still 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.
- 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 9% of adults on Ultomiris in the gMG trial and 3% on placebo.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
Common side effects in the gMG trial
Among 86 adults on Ultomiris in the gMG trial, diarrhea was reported in 15% and upper respiratory tract infection in 14%.
- On placebo, those figures were 12% and 8%.
- Dizziness (9%), back pain (8%), stomach pain (6%) and urinary tract infection (6%) were also more common than on placebo.FDA label
Serious side effects in the gMG trial
Serious side effects were reported in 23% of adults on Ultomiris and 16% on placebo.
- Infections were the most frequent, in at least 9% on Ultomiris and 4% on placebo.
- One patient on Ultomiris died of COVID-19 pneumonia, and one infection led a patient to stop treatment.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
Pneumonia and Hib vaccines, a question to ask
The label says to give pneumococcal and Hib vaccines according to ACIP advice, and that children may be at higher risk.
- The Medication Guide mentions these vaccines only for children, so ask your neurologist whether either applies to you.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 18 or older, a positive AChR antibody test and MGFA class II to IV. It also asks for a baseline MG-ADL score of 6 or more, or a QMG score above 9. Your neurologist's office sends the records that show each of these points.FEP Blue policy
- The plan asks what you tried firstThe FEP policy asks for an inadequate response, intolerance or contraindication to 1 listed medicine. The list is an acetylcholinesterase inhibitor, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate and cyclophosphamide. The office documents which one applies to you and why.FEP Blue policy
- Another C5 inhibitor is on your recordThe FEP policy does not approve Ultomiris together with another C5 complement inhibitor for gMG, and its list names Soliris and Zilbrysq. Your neurologist's office sends the plan your current medicine list.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 gMG sample letter of medical necessity and a sample appeal letter for your neurologist's office. It also posts a guide to peer-to-peer reviews, a step some offices use 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 drop of at least 2 points in the MG-ADL or QMG score from baseline. Alexion Access Navigator posts a reauthorization guide for offices, so ask the office when the renewal is due.FEP Blue policy
Blue Cross Blue Shield Federal Employee Program prior authorization policy, July 1, 2026
- Age 18 or older
- Generalized myasthenia gravis with a positive serologic test for anti-AChR antibodies
- Myasthenia Gravis Foundation of America (MGFA) clinical classification class II to IV
- A documented baseline MG-ADL total score of 6 or more, or a QMG total score above 9
- Inadequate response, intolerance or contraindication to 1 of these: an acetylcholinesterase inhibitor, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate or cyclophosphamide
- No dual therapy with another prior authorization C5 complement inhibitor for gMG; the policy's list names Soliris, Ultomiris and Zilbrysq
- 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 of at least 2 points in the MG-ADL or QMG total score from 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 gMG 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
- 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 neurologist's office, a Field Reimbursement Manager plus gMG 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?
- 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?
- If I need plasma exchange or IVIG, who arranges the extra Ultomiris dose within 4 hours?
- Is my baseline MG-ADL or QMG score on file for the insurance renewal?
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 neurologist 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. Your neurologist decides which doses you still need before starting.
How often is Ultomiris given for myasthenia gravis?
After a starting dose, the second infusion comes 2 weeks later, then one every 8 weeks. Each dose depends on your weight, and the gMG 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 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 neurologist 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, then one every 8 weeks.
What happens if I need plasma exchange or IVIG?
The label says both lower Ultomiris levels in the blood and calls for an extra dose. That dose is given within 4 hours after each plasma exchange session, or after an IVIG cycle is complete.
Is Ultomiris approved if I do not have AChR antibodies?
No. The gMG approval covers adults who are anti-acetylcholine receptor (AChR) antibody positive. The label's trial enrolled only adults with a positive AChR antibody test.
What did the trial in the label show for myasthenia gravis?
In a 26-week trial of 175 adults, MG-ADL scores improved by 3.1 points on Ultomiris and 1.4 points on placebo. At least a 3-point improvement was seen in 56.7% on Ultomiris and 34.1% on placebo.
Does Ultomiris need regular blood tests for myasthenia gravis?
The label sets no scheduled blood test for gMG. It asks the care team to watch for signs of infection at all times and for reactions during and after each infusion.
Is Ultomiris used for other conditions?
Yes. The label also covers 2 blood conditions called PNH and aHUS, neuromyelitis optica spectrum disorder (NMOSD) and IgA nephropathy. This page covers only the generalized myasthenia gravis use of Ultomiris.
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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™ CoPay Program Terms and Conditions, US/ALL/1223 V1 12/2024, Alexion Pharmaceuticals, November 13, 2026.
- Alexion Access Navigator | Ultomiris gMG, Alexion Pharmaceuticals, November 13, 2026.
- 5.85.033 Ultomiris (ravulizumab-cwvz), Blue Cross Blue Shield Federal Employee Program, July 1, 2026.
- BLA 761108/S-23 supplement approval letter, generalized myasthenia gravis and Ultomiris REMS modification, FDA, April 27, 2022.
- Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis (NCT03920293, Study ALXN1210-MG-306), 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 neurologist. Found an error? Use the report link in the footer and it will be checked against the source.