Your first 90 days
Your first 90 days on Soliris for NMOSD
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.
Soliris has no bottle to refill, because a healthcare provider gives every dose into a vein. The first 5 infusions come a week apart, and after that there is one every 2 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 REMS, Alexion's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Soliris 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 AQP4 antibodies
The label approves Soliris for NMOSD only in adults who are anti-aquaporin-4 (AQP4) antibody positive.
- The Medication Guide says it is not known if Soliris is safe and effective in children with NMOSD.
- The Aetna policy shown further down this page asks for a positive AQP4 antibody result as well.FDA label
Meningococcal vaccines, at least 2 weeks before the first dose
Soliris 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 Soliris 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 has one contraindication, which means a situation where the drug must not be started.
- Soliris is not started in anyone with an unresolved serious Neisseria meningitidis infection.
- The REMS also has the prescriber check for this before the first dose.FDA label
Pneumonia and Hib vaccines, a question to ask
The label says Soliris 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 neurologist whether either applies to you.FDA label
A certified prescriber, and the counseling the REMS requires
Your neurologist must be enrolled in the ULTOMIRIS and SOLIRIS REMS, a safety program the FDA requires for both drugs.
- 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 Soliris.
- Before each prescription is dispensed, they contact the REMS to confirm that your prescriber is certified.
- A clinic outside the program cannot give it, so the office books a site that is enrolled.FDA REMS page
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 it, 5 weekly infusions through day 29, then one every 2 weeks. 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.
- OneSource says its specialists help you make sense of your health insurance coverage.
- 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 5 infusions, each a week apart.
- The site must be certified in the REMS, and it checks your vaccine status before the first dose.
First infusion, 900mg
The first dose for adults with NMOSD is 900mg, given into a vein over 35 minutes.
- Staff watch you for at least 1 hour after it ends.
- Put the Patient Safety Card in your wallet the same day.
Second weekly infusion, 900mg
The label gives 900mg once a week for the first 4 weeks.
- This is the second of those 4 weekly doses.
Third weekly infusion, 900mg
This is the third of the 4 weekly 900mg doses.
- If you miss an infusion, the Medication Guide says to call your healthcare provider right away.
Fourth weekly infusion, 900mg
This is the last of the 4 weekly 900mg doses.
- The next infusion, one week later, is a larger dose.
Fifth infusion, the first 1,200mg dose
One week after the fourth dose, the label moves the dose up to 1,200mg.
- From here the infusions come every 2 weeks instead of every week.
An infusion every 2 weeks from here
Each 1,200mg infusion comes 2 weeks after the one before, for as long as your neurologist prescribes it.
- Staff still watch you for at least 1 hour after every infusion.
An infusion every 2 weeks from here, number 2
An infusion every 2 weeks from here, number 3
An infusion every 2 weeks from here, number 4
Three months in
By now the label's schedule adds up to 9 infusions, with the tenth due on day 99.
- In the label's main NMOSD trial of 143 adults, the risk of a relapse was 94% lower on Soliris than on placebo.
- The label sets no scheduled blood test for NMOSD, so your neurologist decides how to follow you.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Soliris 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 July 8, 2026, read from the FDA's label database today. FDA label
- October 2026
The FDA approved changes to the REMS brochure, Patient Guide and website on October 21, 2026. The changes add a new use for Ultomiris, the other drug in the program. The FDA's REMS page still listed June 1, 2026 as its last update on November 13, 2026.FDA letter
- June 2026
A label supplement approved on June 30, 2026 made editorial changes only. It added commas to large numbers, moved the storage instructions for diluted Soliris and renamed the diluent to match its official title.FDA letter
- February 2025
The FDA added generalized myasthenia gravis in children 6 years and older to the label. The NMOSD use, for adults only, did not change.FDA letter
- March 2024
The Soliris REMS was combined with the Ultomiris REMS into one program, the ULTOMIRIS and SOLIRIS REMS, on March 22, 2024.FDA letter
- June 2019
The FDA approved Soliris for NMOSD in adults who are anti-aquaporin-4 (AQP4) antibody positive on June 27, 2019.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
The Medication Guide says your healthcare provider gives Soliris through an IV line, usually over 35 minutes in adults.
- If a reaction happens, the label lets the provider slow or stop the infusion.
- A slowed infusion should not run longer than 2 hours in total for an adult.FDA label
- The dose is the same for every adult
For adults with NMOSD the label gives 900mg weekly for the first 4 weeks and 1,200mg for the fifth dose a week later.
- After that the dose is 1,200mg every 2 weeks.
- The adult dose does not depend on weight.FDA label
- If you miss an infusion
The Medication Guide says to call your healthcare provider right away.
- The label allows doses within 2 days of the planned day in its sections on another condition and on children.
- Its paragraph on adult NMOSD dosing does not repeat that line, so ask your neurologist how much a visit can move.FDA label
- Fever is a call, not a wait
The Medication Guide lists fever, fever with a high heart rate, headache and fever, confusion and muscle aches with flu-like symptoms as warning signs.
- Also listed are fever and a rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, and eyes sensitive to light.
- It says to call your healthcare provider or get emergency medical 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 3 months after the last dose.
- The Medication Guide says the risk of meningococcal infection may continue for several weeks after the last dose.
- 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
- Plasma exchange changes the dose
Plasma exchange and plasmapheresis lower the amount of Soliris in the blood.
- For adults with NMOSD the label calls for an extra dose within 60 minutes after each session, 600mg for someone on the usual doses.
- Fresh frozen plasma calls for an extra 300mg dose 60 minutes before each infusion of plasma.FDA label
- IVIG and FcRn blockers, tell your neurologist first
The label's extra-dose table for IVIG is written for people with myasthenia gravis, and it gives no IVIG rule for NMOSD.
- Drugs called neonatal Fc receptor (FcRn) blockers may lower Soliris levels and make it work less well.
- Tell your neurologist about either of these before they start.
- The Medication Guide also says to keep a list of your medicines and vaccines to show your healthcare provider.FDA label
- What the label says about stopping
The label sets monitoring periods after stopping only for 2 other conditions, PNH and aHUS, and none for NMOSD.
- It does say the higher risk of meningococcal infection lasts for several weeks after the last dose.
- Whether and when to stop is a decision for you and your neurologist, and the card stays with you for 3 months.FDA label
- Pregnancy and breastfeeding
The Medication Guide says it is not known if Soliris will harm an unborn baby or if it passes into breast milk.
- The label says limited data from pregnancies on Soliris have not identified a concern for specific harms, though they cannot rule out risk.
- Tell your neurologist if you are pregnant, plan to become pregnant, or are breastfeeding or plan to.FDA label
- Gonorrhea risk
The Medication Guide says certain people on Soliris may be at risk of serious infections with gonorrhea.
- It suggests talking with your healthcare provider about your risk, prevention and regular testing.FDA label
- Driving and machinery
The label and Medication Guide carry no warning about driving or using machines.
- Dizziness was reported in 15% of people on Soliris in the NMOSD trial and 13% on placebo.
- The Medication Guide says to tell your healthcare provider about any side effect that bothers you.FDA label
- Biosimilars of Soliris: Bkemv
Bkemv (eculizumab-aeeb) is a biosimilar of Soliris, and its label has listed NMOSD in adults who are AQP4 antibody positive since June 2026.
- It carries the same boxed warning and runs its own program, the BKEMV REMS.
- Your neurologist decides which eculizumab product you get.Bkemv label
- Biosimilars of Soliris: Epysqli
Epysqli (eculizumab-aagh) is a second biosimilar, and its label has also listed NMOSD in AQP4 antibody positive adults since June 2026.
- It carries the same boxed warning and runs its own program, the EPYSQLI REMS.
- Both biosimilar labels give the same NMOSD doses as Soliris.Epysqli label
- How the vials are kept
The label says Soliris vials stay in the refrigerator at 36 to 46 degrees Fahrenheit, in their carton to protect them from light.
- The label also says the vials are never frozen or shaken.
- Each carton holds one 300mg vial, so a 900mg dose uses 3 vials and a 1,200mg dose uses 4.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 muscle aches with flu-like symptoms.
- Fever and a rash, headache with nausea or vomiting, headache with a stiff neck or stiff 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 healthcare provider or get emergency medical care right away, card in hand.FDA label
A reaction during the infusion
Chest pain, trouble breathing or shortness of breath, swelling of your face, tongue or throat, or feeling faint or passing out.
- The Medication Guide says to tell your healthcare provider or nurse right away if any of these happen during an infusion.
- Your provider may then give Soliris more slowly or stop the infusion.FDA label
Common side effects in the NMOSD trial
In the label's NMOSD trial, colds and other upper respiratory infections occurred in 29% on Soliris against 13% on placebo.
- Nose and throat swelling was 21% against 19%, diarrhea 16% against 15%, and back pain and dizziness each 15% against 13%.
- Flu was 11% against 4%, joint pain 11% in both groups, sore throat 10% against 6% and bruising 10% against 4%.FDA label
Other infections
The label says Soliris also raises the risk of infections from Streptococcus pneumoniae, Haemophilus influenzae and, to a lesser extent, gonorrhea bacteria.
- The Medication Guide adds that certain fungal infections, called aspergillus, may happen in people with a weak immune system or low white blood cells.
- Tell your healthcare provider if you have an infection or a fever.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 REMS has certified sites 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 rather than a denial.FDA REMS page
- The AQP4 antibody result or the specialist is missingThe Aetna policy below asks for a positive AQP4 antibody test. It also asks for at least one core clinical feature of NMOSD, such as optic neuritis or acute myelitis. It also asks that a neurologist prescribe Soliris or be consulted. Your neurologist's office sends the lab report and clinic notes.Aetna policy
- Another NMOSD biologic is on your recordThe Aetna policy says Soliris will not be given at the same time as other biologics for NMOSD. Your neurologist's office lists your current NMOSD treatments in the request it sends.Aetna policy
- Your plan prefers a different eculizumab productThe Aetna policy covers Soliris, Bkemv and Epysqli. It says Aetna commercial plans may require a trial of a lower-cost preferred drug before a higher-cost one in the same class.Aetna policy
- A denial your neurologist wants to appealAlexion Access Navigator posts an NMOSD sample letter of medical necessity and a sample appeal letter for doctors' offices. It also posts a guide to peer-to-peer review, 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 and may help with some infusion costs. Medicare, Medicaid and other government plans are excluded, and OneSource says it can connect those patients with third-party resources.OneSource
- The vaccines themselves cost moneyOneSource says it may 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
Aetna prior authorization policy, November 10, 2026
- Anti-aquaporin-4 (AQP4) antibody positive
- At least one core clinical feature of NMOSD: optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy or acute diencephalic syndrome with typical MRI lesions, or symptomatic cerebral syndrome with typical brain lesions
- Not given at the same time as other biologics for the treatment of NMOSD
- Prescribed by, or in consultation with, a neurologist
- To continue: no unacceptable toxicity or disease progression, and a positive response such as fewer relapses
Approval length. The bulletin does not state how long an approval lasts; it lists separate criteria for a first approval and for continuing treatment.
This is Aetna Clinical Policy Bulletin 0807 for commercial medical plans, last reviewed on November 10, 2026, after the current Soliris label. It covers Soliris, Bkemv and Epysqli, requires precertification and applies a site of care policy. Its background text still says the 2 biosimilars lack the NMOSD use, which their June 2026 labels now include. It is here as an example of what a plan asks for, not as a rule. Aetna 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.
- Specialists who help you make sense of your health insurance coverage, answer questions about treatment with Soliris and connect you to community resources OneSource overview
- Vaccination support for enrolled patients, including help finding a vaccination site and information on resources that may cover vaccine costs OneSource vaccines
- The Alexion OneSource CoPay Program for commercial insurance, as little as $0 for Soliris, which may also help with some infusion costs
- 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, and annual maximums may apply, 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
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?
- If I need plasma exchange for an attack, who arranges the extra Soliris dose afterward?
- Has my copay program been applied to both the medicine and the infusion fee?
- Who books my infusions every 2 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 Soliris 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 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 Soliris?
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. The Medication Guide mentions those 2 vaccines only for children, so ask your neurologist.
How often is Soliris given for NMOSD?
Once a week for the first 5 infusions, then once every 2 weeks. The first 4 doses are 900mg each, and every dose from the fifth one on is 1,200mg. By day 90 that adds up to 9 infusions.
How long does a Soliris infusion take?
The Medication Guide says the infusion usually takes 35 minutes in adults. Staff then watch you for at least 1 hour for signs of an infusion reaction. If the infusion is slowed because of a reaction, the label says it should not run past 2 hours in total.
What if I miss a Soliris infusion?
The Medication Guide says to call your healthcare provider right away. The label's paragraph on adult NMOSD dosing does not state how many days a dose may move, so your neurologist decides.
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 3 months after the last dose.
What happens to Soliris if I need plasma exchange for an attack?
Plasma exchange lowers Soliris levels in the blood, so the label calls for an extra dose within 60 minutes after each session. For an adult on the usual NMOSD doses, that extra dose is 600mg. The label gives the same rule for plasmapheresis, a similar procedure.
Does Soliris need regular blood tests?
The label sets no scheduled blood test for NMOSD. Your neurologist decides which checks you need and how often.
Are there biosimilars of Soliris for NMOSD?
Yes, there are 2: Bkemv (eculizumab-aeeb) and Epysqli (eculizumab-aagh) list NMOSD in adults who are AQP4 antibody positive on labels updated in June 2026. Both carry the same boxed warning, and each has its own REMS and Patient Safety Card.
Can I get Soliris at home?
The Medication Guide says a healthcare provider gives every dose, and the REMS allows only certified healthcare settings and pharmacies to dispense it. Alexion posts a guide on home infusion access for doctors' offices. Ask your neurologist and your plan whether home infusion is an option for you.
Free email alert
Hear when the Soliris label changes
One email the day the FDA revises the Soliris label, with what changed in plain words. No trial alerts, no newsletter.
Label changes for Soliris 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 Neuromyelitis optica spectrum disorder (NMOSD) for new trials, FDA decisions and label changes for every treatment.
Sources
- SOLIRIS (eculizumab) injection, for intravenous use, prescribing information and Medication Guide, SPL version 44, label revised 06/2026, Medication Guide revised 02/2025, Alexion Pharmaceuticals, via openFDA, July 8, 2026.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Ultomiris and Soliris (eculizumab), BLA 125166 and BLA 761108, REMS last update 06/01/2026, FDA, June 1, 2026.
- Alexion OneSource™ | SOLIRIS | Financial Assistance, Alexion Pharmaceuticals, November 12, 2026.
- Alexion OneSource™ CoPay Program Terms and Conditions, US/ALL/1223 V1 12/2024, Alexion Pharmaceuticals, November 12, 2026.
- Alexion OneSource™ | SOLIRIS | About OneSource™, Alexion Pharmaceuticals, November 12, 2026.
- Alexion OneSource™ | SOLIRIS | Fill Out a Start Form, Alexion Pharmaceuticals, November 12, 2026.
- Alexion OneSource™ | SOLIRIS | Vaccination Support, Alexion Pharmaceuticals, November 12, 2026.
- Alexion Access Navigator | Soliris NMOSD, Alexion Pharmaceuticals, November 12, 2026.
- Eculizumab - Medical Clinical Policy Bulletins | Aetna, Number 0807, Aetna, November 10, 2026.
- BKEMV (eculizumab-aeeb) label, SPL version 8, Indications and Usage (1.4) changed 06/2026, Amgen, via openFDA, July 2, 2026.
- EPYSQLI (eculizumab-aagh) label, SPL version 5, Indications and Usage (1.4) changed 06/2026, Teva Pharmaceuticals USA, via openFDA, July 6, 2026.
- BLA 761108/S-046 and BLA 125166/S-455 accelerated approval letter, Ultomiris IgA nephropathy and REMS modification, FDA, October 21, 2026.
- BLA 125166/S-454 supplement approval letter, Soliris labeling, FDA, June 30, 2026.
- BLA 125166/S-448 and BLA 761108/S-038 supplement approval letter, Soliris pediatric gMG and REMS modification, FDA, February 28, 2025.
- BLA 125166/S-443 supplement approval letter, combined REMS with Ultomiris, FDA, March 22, 2024.
- BLA 125166/S-431 supplement approval letter, Soliris for NMOSD, FDA, June 27, 2019.
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.