Your first 90 days
Your first 90 days on Soliris for PNH
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
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 9 things in the way, in order.
A PNH diagnosis, in an adult
The label approves Soliris for people with PNH to reduce hemolysis, and it gives the PNH dose for ages 18 and older.
- The Medication Guide says it is not known if Soliris is safe and effective in children with PNH.
- The Aetna policy shown further down this page asks for a flow cytometry test confirming the diagnosis.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 hematologist 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 hematologist whether either applies to you.FDA label
A certified prescriber, and the counseling the REMS requires
Your hematologist 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
Blood thinners stay as they are
In the label's main PNH trial, about half of the patients were taking a blood thinner, also called an anticoagulant.
- The label says treatment with Soliris should not alter anticoagulant management.
- It explains that the effect of stopping a blood thinner during Soliris treatment has not been established.FDA label
OneSource enrollment, which you sign too
You or your hematologist's office can enroll you in Alexion OneSource online, by email or by fax at 1-800-420-5150.
- 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 hematologist'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 hematologist which doses are due now and which, if any, come later.
Last day for the vaccines to count
Shots given after this point fall inside the 2-week window.
- If treatment cannot wait, the label says antibiotics are added and the vaccines are given as soon as possible.
Approval, then booking a certified site
Once the plan approves, the office books the first 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, 600mg
The first dose for adults with PNH is 600mg, 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, 600mg
The label gives 600mg once a week for the first 4 weeks.
- In its main PNH trial, average LDH, a blood marker of red cell breakdown, fell from 2,200U/L to 700U/L by week one.
Third weekly infusion, 600mg
This is the third of the 4 weekly 600mg doses.
- If you miss an infusion, the Medication Guide says to call your healthcare provider right away.
Fourth weekly infusion, 600mg
This is the last of the 4 weekly 600mg doses.
- The next infusion, one week later, is a larger dose.
Fifth infusion, the first 900mg dose
One week after the fourth dose, the label moves the dose up to 900mg.
- From here the infusions come every 2 weeks instead of every week.
An infusion every 2 weeks from here
Each 900mg infusion comes 2 weeks after the one before, for as long as your hematologist prescribes it.
- The label says to give each dose on its planned day or within 2 days of it.
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 PNH trial, 51% of people on Soliris needed no transfusion over 26 weeks, against 0% on placebo.
- The label sets no scheduled blood test during treatment, so your hematologist 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
- June 2026
The FDA approved a labeling supplement for Soliris on June 30, 2026. The approval letter lists layout changes, such as moving the storage text for diluted Soliris to the end of section 2.6.FDA letter
- February 2025
The REMS materials were changed on February 28, 2025 to match a new Soliris use, generalized myasthenia gravis in children 6 years and older.FDA REMS page
- March 2024
The Soliris REMS and the Ultomiris REMS were merged into a single program on March 22, 2024.FDA REMS page
- March 2007
The FDA first approved Soliris on March 16, 2007.Drugs@FDA
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 PNH dose is the same for every adult
For adults with PNH the label gives 600mg weekly for the first 4 weeks and 900mg for the fifth dose a week later.
- After that the dose is 900mg every 2 weeks.
- The adult dose does not depend on weight, and it is lower than the adult dose the label gives for its other uses.FDA label
- On schedule, or within 2 days of it
For PNH the label says to give Soliris at the planned time points or within 2 days of them.
- It ties that line to its warning about hemolysis after Soliris is stopped.
- If you miss an infusion, the Medication Guide says to call your healthcare provider right away.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.
- The label says vaccination does not eliminate the risk, and serious infections have occurred in vaccinated patients too.FDA label
- What the label says about stopping
The Medication Guide says stopping Soliris may cause breakdown of your red blood cells due to PNH.
- The label calls for monitoring for at least 8 weeks after the last dose to detect hemolysis.
- Whether and when to stop is a decision for you and your hematologist, and the card stays with you for 3 months.FDA label
- Blood thinners
The label says treatment with Soliris should not alter anticoagulant management.
- In its long-term PNH study, most patients were also taking anticoagulants, and stopping them during Soliris treatment was not studied.
- Any change to a blood thinner is a decision for your prescriber.FDA label
- Plasma exchange and fresh frozen plasma
The label says plasma exchange, plasmapheresis and fresh frozen plasma can lower the amount of Soliris in the blood.
- Its extra-dose table is written for 3 other conditions, aHUS, gMG and NMOSD, and does not name PNH.
- Your hematologist decides what that means for your dose.FDA label
- FcRn blockers and other medicines
Drugs called neonatal Fc receptor (FcRn) blockers may lower Soliris levels and make it work less well, according to the label.
- The Medication Guide says to tell your healthcare provider about all the medicines you take.
- It also says to keep a list of your medicines and vaccines to show your healthcare provider and pharmacist.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.
- It also says untreated PNH in pregnancy carries risks for the mother and the baby.
- Tell your hematologist 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.
- Headache was reported in 44% of people on Soliris in the PNH trial and 27% 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 lists PNH with the same dose and schedule.
- It carries the same boxed warning and runs its own program, the BKEMV REMS.
- Your hematologist decides which eculizumab product you get.Bkemv label
- Biosimilars of Soliris: Epysqli
Epysqli (eculizumab-aagh) is a second biosimilar, and its label also lists PNH with the same dose and schedule.
- It carries the same boxed warning and runs its own program, the EPYSQLI REMS.
- Both biosimilar labels call for the same 8 weeks of monitoring after stopping.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 600mg dose uses 2 vials and a 900mg dose uses 3.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
Red cell breakdown after stopping
The Medication Guide lists problems that can happen when red blood cells break down after Soliris is stopped.
- They are a drop in your red blood cell count, a drop in your platelet count, kidney problems and blood clots.
- Confusion, difficulty breathing and chest pain are on the same list.
- Your healthcare provider will need to monitor you closely for at least 8 weeks after stopping.FDA label
Common side effects in the PNH trial
In the label's placebo-controlled PNH trial, headache occurred in 44% on Soliris against 27% on placebo.
- Nose and throat swelling was 23% against 18%, back pain 19% against 9% and nausea 16% against 11%.
- Tiredness was 12% against 2%, and cough was 12% against 9%.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.
- 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 flow cytometry report or the specialist is missingThe Aetna policy below asks for flow cytometry showing a deficiency of GPI-anchored proteins, the test that confirms PNH. It also asks for clinical signs of the disease, such as LDH above 1.5 times the upper limit of normal or a blood clot. It also asks that a hematologist prescribe Soliris or be consulted. Your hematologist's office sends the lab reports and clinic notes.Aetna policy
- Another complement inhibitor is on your recordThe Aetna policy says Soliris will not be used together with another complement inhibitor for PNH, such as Empaveli, Fabhalta, PiaSky or Ultomiris. The same policy allows Voydeya to be used at the same time as Soliris. Your hematologist's office lists your current PNH 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 hematologist wants to appealAlexion Access Navigator posts a PNH sample letter of medical necessity and a PNH appeal letter for doctors' offices. It also posts a prior authorization checklist for PNH and 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. The clinic's infusion fee may then fall on you.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
- PNH confirmed by a deficiency of GPI-anchored proteins, for example at least 5% PNH cells, at least 51% of GPI-anchored protein deficient polymorphonuclear cells
- Flow cytometry used to show that deficiency
- Clinical signs of the disease, for example LDH above 1.5 times the upper limit of normal, thrombosis, renal dysfunction, pulmonary hypertension or dysphagia
- Not used with another complement inhibitor for PNH, such as Empaveli, Fabhalta, PiaSky or Ultomiris; use with Voydeya is allowed
- Prescribed by, or in consultation with, a hematologist
- To continue: no unacceptable toxicity or disease progression, and a positive response such as better hemoglobin or normalized LDH
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 PNH criteria do not mention the meningococcal vaccines, which the label and the REMS require. 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
- CoPay help with infusion costs is not open to residents of Massachusetts or Rhode Island, who can still get help with medicine costs 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?
- Which blood tests will you use to follow my PNH, and how often?
- 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 treatment is urgent. In that case the label says antibiotics are given and the vaccines follow as soon as possible. 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 hematologist.
How often is Soliris given for PNH?
Once a week for the first 5 infusions, then once every 2 weeks. The first 4 doses are 600mg each, and every dose from the fifth one on is 900mg. 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. For PNH the label says each dose is given at its planned time point or within 2 days of it.
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 if Soliris is stopped?
The Medication Guide says stopping may cause breakdown of your red blood cells due to PNH. The label calls for monitoring for at least 8 weeks after the last dose to detect hemolysis. The decision to stop belongs to you and your hematologist.
Does Soliris need regular blood tests?
The label sets no scheduled blood test during treatment for PNH. Its trials tracked hemolysis mainly through LDH, a blood marker of red cell breakdown. Your hematologist decides which checks you need and how often.
Are there biosimilars of Soliris for PNH?
Yes, there are 2: Bkemv (eculizumab-aeeb) and Epysqli (eculizumab-aagh), and both labels list PNH at the same dose as Soliris. 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 hematologist 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, 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 PNH, 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 (1.1) and Dosage and Administration (2.2) for PNH, Amgen, via openFDA, July 2, 2026.
- EPYSQLI (eculizumab-aagh) label, SPL version 5, Indications and Usage (1.1) and Dosage and Administration (2.2) for PNH, Teva Pharmaceuticals USA, via openFDA, July 6, 2026.
- BLA 125166/S-454 Supplement Approval letter, Soliris (eculizumab) injection, FDA, June 30, 2026.
- Drugs@FDA: FDA-Approved Drugs, Biologic License Application (BLA): 125166, SOLIRIS, FDA, November 13, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing hematologist. Found an error? Use the report link in the footer and it will be checked against the source.