Your first 90 days
Your first 90 days on Soliris 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.
Soliris has no bottle to refill, because a healthcare provider gives every dose into a vein. For adults, 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 9 things in the way, in order.
A blood test showing AChR antibodies
The label approves Soliris for generalized myasthenia gravis only in people who are anti-acetylcholine receptor (AChR) antibody positive.
- It covers adults and children 6 years and older.
- The Medication Guide says it is not known if Soliris is safe and effective in children with gMG below 6 years of age.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
For children, pneumonia and Hib vaccines too
The label says children on Soliris may be at higher risk of serious infections from Streptococcus pneumoniae and Haemophilus influenzae type b (Hib).
- It says to give pneumococcal and Hib vaccines according to ACIP advice.
- The Medication Guide says a child treated with Soliris should receive both vaccines.
- Adults can ask their neurologist whether either one applies to them.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
A current weight, for children
The label sets the dose for children 6 years and older with gMG by body weight.
- A child who weighs 40kg (88 pounds) or more gets the adult doses.
- Children who weigh less get smaller doses on a slightly different schedule, which the neurologist works out.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 on the adult schedule, 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 for adults
The first dose for adults with gMG is 900mg, given into a vein over 35 minutes.
- Staff watch you for at least 1 hour after it ends.
- The label says to carry the Patient Safety Card at all times from here on.
Second weekly infusion, 900mg
The label gives adults 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 adult 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 adult schedule adds up to 9 infusions, with the tenth due on day 99.
- The label says available data suggest a clinical response is usually reached by 12 weeks of treatment.
- The label sets no scheduled blood test for gMG, 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 changed wording and layout 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 who are AChR antibody positive on February 28, 2025. The REMS materials were updated to match.FDA letter
- March 2024
The Soliris REMS and the Ultomiris REMS were merged into a single program, the ULTOMIRIS and SOLIRIS REMS, on March 22, 2024.FDA REMS page
- October 2017
The FDA approved Soliris for adults with generalized myasthenia gravis who are AChR antibody positive on October 23, 2017.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.
- In children it usually takes 1 to 4 hours.
- 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 adult dose is the same for every adult
For adults with gMG 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
- Children 6 and older, dosed by weight
At 40kg (88 pounds) or more, the label gives children the adult doses.
- From 30kg to under 40kg (about 66 to 88 pounds), it gives 600mg in each of the first 2 weeks.
- The dose is then 900mg at week 3 and 900mg every 2 weeks.
- From 20kg to under 30kg (about 44 to 66 pounds), every dose is 600mg on that same timing.
- From 10kg to under 20kg (about 22 to 44 pounds), it is 600mg once, then 300mg at week 2 and every 2 weeks.FDA label
- If you miss an infusion
The Medication Guide says to call your healthcare provider right away.
- For children, the label says to give doses at the planned times or within 2 days of them.
- Its paragraph on adult gMG 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.
- It says to show the card to any healthcare provider who treats you, so they can diagnose and treat you 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 gMG the label calls for an extra dose within 60 minutes after each session.
- That extra dose is 600mg when the most recent dose was 600mg or more, and 300mg when it was 300mg.
- Fresh frozen plasma calls for an extra 300mg dose 60 minutes before each infusion of plasma.FDA label
- IVIG changes the dose too
For people with gMG, the label requires an extra Soliris dose when IVIG is given regularly.
- The extra dose is 600mg per IVIG cycle when the most recent Soliris dose was 900mg or more, and 300mg when it was 600mg or less.
- With IVIG every 4 weeks or more often, it is given along with a scheduled Soliris dose.
- With IVIG less often than that, it is given at the next scheduled Soliris dose after the cycle.
- IVIG used as acute rescue therapy needs no extra dose.FDA label
- FcRn blockers, tell your neurologist first
Drugs called neonatal Fc receptor (FcRn) blockers may lower Soliris levels and make it work less well, the label says.
- The Aetna policy on this page names Vyvgart, Vyvgart Hytrulo, Rystiggo and Imaavy as drugs of this kind.
- The Medication Guide also says to keep a list of your medicines and vaccines to show your healthcare provider.FDA label
- Your other myasthenia medicines
In the label's gMG trial, over 95% of people in each group were receiving acetylcholinesterase inhibitors, and 98% were receiving immunosuppressant therapies.
- The label gives no instruction about changing those medicines.
- Any change to them is your neurologist's decision.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 gMG.
- 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.
- The Medication Guide says to tell your healthcare provider 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.
- The Medication Guide says to tell your healthcare provider about any side effect that bothers you or does not go away.FDA label
- Biosimilars of Soliris: Bkemv
Bkemv (eculizumab-aeeb) is a biosimilar of Soliris, and its label lists gMG in adults who are AChR antibody positive.
- It does not list gMG in children.
- 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 also lists gMG in AChR antibody positive adults only.
- It carries the same boxed warning and runs its own program, the EPYSQLI REMS.
- Both biosimilar labels give the same adult gMG 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.
- It says to call your healthcare provider or get emergency medical care right away.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 gMG trial
The Medication Guide names muscle and joint pain as the most common side effect in people with gMG.
- In the label's 26-week trial it occurred in 15% on Soliris against 8% on placebo.
- Stomach-area pain and swelling of the legs or feet were each 8% against 5%.
- Herpes simplex infections were 8% against 2%, bruising 8% against 3% and fever 7% against 3%.FDA label
Side effects seen with longer treatment
In the trial's long-term extension, the label lists headache in 26% and pain or swelling of the nose or throat in 24%.
- Diarrhea was reported in 15%, joint pain in 12%, colds and other upper respiratory infections in 11% and nausea in 10%.FDA label
Side effects in children
The label describes a 26-week study of 11 children with gMG aged 12 to 17 years.
- Side effects in that study were consistent with those seen in adults with gMG.
- For children 6 to under 12 years, the label says safety is expected to be similar.FDA label
Other infections
The label says people on Soliris may be more open to 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.
- It says to 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 AChR antibody result, the scores or the specialist are missingThe Aetna policy below asks for a positive AChR antibody test and an MGFA class of II to IV. It also asks for an MG-ADL score of 5 or more, and for a neurologist to prescribe Soliris or be consulted. Your neurologist's office sends the lab report and clinic notes.Aetna policy
- Earlier treatments are not documentedThe Aetna policy asks for an inadequate response or intolerable side effect with at least 2 immunosuppressive therapies over at least 12 months. One immunosuppressive therapy plus IVIG over at least 12 months also counts, as does a documented clinical reason to avoid both. Your neurologist's office sends the treatment history.Aetna policy
- Another myasthenia biologic is on your recordThe Aetna policy says Soliris will not be used with another complement inhibitor such as Ultomiris or Zilbrysq. The same goes for an FcRn blocker such as Vyvgart, Rystiggo or Imaavy, and for Uplizna. Your neurologist's office lists your current 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. The Bkemv and Epysqli labels list gMG for adults only, which matters when the patient is a child.Aetna policy
- A denial your neurologist wants to appealAlexion Access Navigator posts a gMG sample letter of medical necessity and a gMG 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
- 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 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-acetylcholine receptor (AChR) antibody positive
- Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV
- MG activities of daily living (MG-ADL) total score of 5 or more
- An inadequate response or intolerable adverse event to at least 2 immunosuppressive therapies over at least 12 months, or to at least 1 immunosuppressive therapy and IVIG over at least 12 months, or a documented clinical reason to avoid immunosuppressive agents and IVIG
- Not used in combination with another complement inhibitor (such as Ultomiris or Zilbrysq), a neonatal Fc receptor blocker (such as Imaavy, Vyvgart, Vyvgart Hytrulo or Rystiggo) or Uplizna
- Prescribed by, or in consultation with, a neurologist
- To continue: no unacceptable toxicity or disease progression, and a positive response such as a better MG-ADL score
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 gMG criteria state no age limit, and its text notes that the 2 biosimilars do not carry the gMG use in children. Its MG-ADL threshold of 5 is lower than the score of 6 used to enter the label's trial. 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, 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?
- Does my child 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 get IVIG or plasma exchange, who arranges the extra Soliris dose?
- 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. For children, the Medication Guide adds vaccines against Streptococcus pneumoniae and Hib.
How often is Soliris given for myasthenia gravis?
For adults, 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. Children under 40kg (88 pounds) follow a weight-based schedule in the label.
How long does a Soliris infusion take?
The Medication Guide says the infusion usually takes 35 minutes in adults and 1 to 4 hours in children. Staff then watch you for at least 1 hour for signs of an infusion reaction. If an adult's infusion is slowed because of a reaction, the label says it should not run past 2 hours in total.
How soon does Soliris work for myasthenia gravis?
The label says available data suggest a clinical response is usually reached by 12 weeks of treatment. In its 26-week trial of 125 adults, the MG-ADL daily activity score improved by 4.2 points on Soliris and 2.3 points on placebo.
Can children get Soliris for myasthenia gravis?
Yes, the label covers children 6 years and older with gMG who are AChR antibody positive, with the dose set by body weight. The FDA added this use on February 28, 2025. The Bkemv and Epysqli biosimilar labels list gMG for adults only.
What if I miss a Soliris infusion?
The Medication Guide says to call your healthcare provider right away. For children, the label allows doses within 2 days of the planned day. Its paragraph on adult gMG 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 IVIG or plasma exchange?
Both lower Soliris levels in the blood, so the label adds extra doses. After each plasma exchange session, the extra dose is given within 60 minutes, 600mg for someone on the usual adult doses. With regular IVIG, an adult on the usual doses gets an extra 600mg per IVIG cycle. IVIG given as acute rescue therapy needs no extra dose.
Does Soliris need regular blood tests?
The label sets no scheduled blood test for gMG. Your neurologist decides which checks you need and how often.
Are there biosimilars of Soliris for myasthenia gravis?
Yes, there are 2 for adults: Bkemv (eculizumab-aeeb) and Epysqli (eculizumab-aagh) both list gMG in adults who are AChR antibody positive. Neither label lists gMG in children. 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.
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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 13, 2026.
- Alexion OneSource™ CoPay Program Terms and Conditions, US/ALL/1223 V1 12/2024, Alexion Pharmaceuticals, November 13, 2026.
- Alexion OneSource™ | SOLIRIS | About OneSource™, Alexion Pharmaceuticals, November 13, 2026.
- Alexion OneSource™ | SOLIRIS | Fill Out a Start Form, Alexion Pharmaceuticals, November 13, 2026.
- Alexion OneSource™ | SOLIRIS | Vaccination Support, Alexion Pharmaceuticals, November 13, 2026.
- Alexion Access Navigator | Soliris gMG, Alexion Pharmaceuticals, November 13, 2026.
- Eculizumab - Medical Clinical Policy Bulletins | Aetna, Number 0807, Aetna, November 10, 2026.
- BKEMV (eculizumab-aeeb) label, SPL version 8, Indications and Usage (1.3), gMG in adult patients who are anti-AChR antibody positive, Amgen, via openFDA, July 2, 2026.
- EPYSQLI (eculizumab-aagh) label, SPL version 5, Indications and Usage (1.3), gMG in adult patients who are anti-AChR antibody positive, 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-422 supplement approval letter, Soliris for adults with gMG and REMS modification, FDA, October 23, 2017.
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.