Prescribing guide
Soliris (eculizumab)Meningococcal vaccine requirements, REMS, adult and pediatric dosing, plasma exchange and IVIg supplements and prior authorization for generalized myasthenia gravisFor prescribers and their offices treating generalized myasthenia gravis: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
REMS-certified prescriber, MenACWY and MenB vaccination completed or updated at least 2 weeks before day 1 or antibacterial prophylaxis with vaccines as soon as possible, counseling with the Patient Safety Card and Patient Guide, and a REMS-certified healthcare setting or pharmacy that verifies prescriber certification before each dispense.
Example PA threshold
Label: gMG in adult and pediatric patients 6 years and older who are anti-AChR antibody positive. Aetna CPB 0807 example, November 2026: AChR positive, MGFA II to IV, MG-ADL 5 or more, 2 immunosuppressants over 12 months or 1 plus IVIG, neurologist. Label trial: MGFA II to IV, MG-ADL 6 or more, failed 2 or more ISTs over 1 year or 1 IST with chronic PE or IVIg.
Monitoring
Meningococcal infection at any time, at least 1 hour of observation after each infusion, revaccination per ACIP for the duration of therapy, supplemental doses with plasma exchange and maintenance IVIg; no scheduled laboratory test is written into the label for gMG.
Support line
Alexion OneSource, 1-888-765-4747, Monday to Friday 8:30 AM to 8 PM ET, insurance navigation, vaccination support, CoPay Program as little as $0 for commercial plans (annual maximums may apply; Massachusetts and Rhode Island residents get medication but not infusion cost help), enrollment fax 1-800-420-5150; the label lists the same number for the REMS.
Give your patient their plan
A one-page handout for starting Soliris, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/soliris-myastheniaBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Confirm the indication | gMG in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive. Safety and effectiveness in pediatric patients with gMG below 6 years have not been established. | FDA label |
| Certify in the ULTOMIRIS and SOLIRIS REMS | Review the Prescribing Information, Healthcare Provider Safety Brochure, Patient Safety Card and Patient Guide, then submit the Prescriber Enrollment Form. Counsel with the card and guide and give the patient copies. REMS line 1-888-765-4747, www.UltSolREMS.com per the label. | FDA REMS page |
| Vaccinate | Complete or update vaccination against Neisseria meningitidis serogroups A, C, W, Y and B at least 2 weeks before the first dose, per current ACIP recommendations for complement inhibitor recipients. ACIP's schedule for these patients differs from the vaccine prescribing information, so prior standard vaccination may not meet it. | FDA label |
| Or prophylaxis | If urgent therapy is indicated in a patient not up to date, give antibacterial drug prophylaxis and the vaccines as soon as possible; the REMS requires the prescriber to write the prophylaxis prescription. The label says optimal regimens and durations have not been studied. | FDA label |
| Contraindication | Do not initiate in a patient with unresolved serious Neisseria meningitidis infection. The REMS lists this assessment before treatment initiation. | FDA REMS page |
| Pneumococcal and Hib | Section 5.3: children treated with Soliris may be at increased risk of serious S. pneumoniae and Hib infection; vaccinate against both per ACIP. Section 8.4 repeats this for pediatric use, and section 17 and the Medication Guide direct it to parents and caregivers. Not a REMS element. | FDA label |
| Weight, for pediatric patients | Table 1 dosing for gMG at 6 years and older is by body weight band: 40kg and over, 30 to under 40kg, 20 to under 30kg, 10 to under 20kg, 5 to under 10kg. | FDA label |
| Book a certified site | Certified healthcare settings and pharmacies contact the REMS to verify prescriber certification before dispensing each prescription. They assess and document meningococcal vaccination status, including prophylaxis if needed, before the first dose, and for up to 6 months after it in patients not initially up to date. | FDA REMS page |
| OneSource enrollment | Online, or by email to OneSource@Alexion.com or fax to 1-800-420-5150, with the signed form. Patient and prescriber forms are separate. | OneSource enrollment |
| Biosimilars | Bkemv (eculizumab-aeeb) and Epysqli (eculizumab-aagh) labels list gMG in adult patients who are anti-AChR antibody positive at the same adult dosage; neither lists pediatric gMG. Each has its own REMS, the BKEMV REMS and the EPYSQLI REMS; certification in the ULTOMIRIS and SOLIRIS REMS is separate. | Bkemv label |
Prior authorization criteria and what to document
One public policy as the example: Aetna, November 10, 2026. Approval 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| AChR serostatus | Anti-acetylcholine receptor (AChR) antibody positive | Antibody report with date | Aetna policy |
| Severity | MGFA clinical classification II to IV, and MG-ADL total score greater than or equal to 5 | Clinic note with MGFA class and dated MG-ADL score | Aetna policy |
| Prior therapy | Inadequate response or intolerable adverse event to at least two immunosuppressive therapies over at least 12 months (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, tacrolimus); or to at least one immunosuppressive therapy and IVIG over at least 12 months; or a documented clinical reason to avoid immunosuppressive agents and IVIG | Medication history with dates, doses and outcomes | Aetna policy |
| Concomitant therapy | Not used in combination with another complement inhibitor (e.g., Ultomiris, Zilbrysq), neonatal Fc receptor blocker (e.g., Imaavy, Vyvgart, Vyvgart Hytrulo, Rystiggo), or Uplizna | Current gMG medication list | Aetna policy |
| Prescriber | Prescribed by or in consultation with a neurologist | Specialty on the request | Aetna policy |
| Continuation | No evidence of unacceptable toxicity or disease progression; positive response, for example improvement in MG-ADL score, MG Manual Muscle Test or MG Composite; same exclusion of combination therapy | Baseline and on-treatment scores | Aetna policy |
| Product and site | CPB 0807 covers Soliris, Bkemv and Epysqli, requires precertification, applies the Site of Care policy for specialty drug infusions, and says commercial plans may require a lower-cost preferred drug first. No approval duration and no age criterion are stated for gMG. | Check the plan's preferred product list before submitting | Aetna policy |
| Pediatric patients and biosimilars | The bulletin states that Bkemv and Epysqli carry Soliris's indications except NMOSD and pediatrics with gMG; the current biosimilar labels confirm gMG in adults only | Patient age on the request if the plan steers to a biosimilar | Epysqli label |
| Appeal tools | Alexion Access Navigator posts gMG common prior authorization criteria, a gMG sample letter of medical necessity, a gMG sample appeal letter, a peer-to-peer review guide, a gMG coding and billing guide, a reauthorization guide and home infusion access considerations | Payer submission packet | Alexion Access Navigator |
Soliris dosing and titration
| When | Label | Source |
|---|---|---|
| Adults, days 1, 8, 15, 22 | 900mg IV weekly for the first 4 weeks. | FDA label |
| Adults, day 29 | 1,200mg for the fifth dose, 1 week after the fourth. | FDA label |
| Adults, every 2 weeks | 1,200mg every 2 weeks thereafter. The sentence allowing doses within 2 days of the scheduled time points appears in 2.2 (PNH) and after Table 1 in 2.4 (pediatric aHUS and gMG); 2.3 does not repeat it for adult gMG. | FDA label |
| Pediatric, 40kg and over | 900mg weekly for the first 4 weeks; 1,200mg at week 5; then 1,200mg every 2 weeks (Table 1). | FDA label |
| Pediatric, 30 to under 40kg | 600mg for the first 2 weeks; 900mg at week 3; then 900mg every 2 weeks (Table 1). | FDA label |
| Pediatric, 20 to under 30kg | 600mg for the first 2 weeks; 600mg at week 3; then 600mg every 2 weeks (Table 1). | FDA label |
| Pediatric, 10 to under 20kg | 600mg single dose at week 1; 300mg at week 2; then 300mg every 2 weeks (Table 1). The 5 to under 10kg band is 300mg at week 1, 300mg at week 2, then 300mg every 3 weeks. | FDA label |
| Pediatric timing | Administer at the recommended time points or within two days of them (2.4). | FDA label |
| Preparation | Dilute to 5mg/mL with an equal volume of 0.9% or 0.45% sodium chloride, 5% dextrose or Ringer's injection: 60mL final volume for 300mg, 120mL for 600mg, 180mL for 900mg, 240mL for 1,200mg. Diluted solution keeps up to 24 hours at 2 to 8°C or room temperature; allow to reach room temperature before use. | FDA label |
| Administration | IV infusion only, never push or bolus, over 35 minutes in adults and 1 to 4 hours in pediatric patients by gravity feed, syringe-type pump or infusion pump. May be slowed or stopped for an adverse reaction; total infusion time should not exceed 2 hours in adults. | FDA label |
| Plasmapheresis or plasma exchange | Most recent dose 600mg or more: 600mg per session. Most recent dose 300mg: 300mg per session. Within 60 minutes after each session (Table 2). | FDA label |
| Fresh frozen plasma | Most recent dose 300mg or more: 300mg per infusion of fresh frozen plasma, 60 minutes prior to each infusion (Table 2). | FDA label |
| IVIg every 4 weeks or more often | Most recent Soliris dose 900mg or more: 600mg per IVIg cycle. 600mg or less: 300mg per IVIg cycle. Given at the same time as the scheduled Soliris dose (Table 3). | FDA label |
| IVIg less often than every 4 weeks | Same supplemental amounts, given at the next scheduled Soliris dose after the last IVIg cycle (Table 3). | FDA label |
| IVIg as acute rescue | No supplemental Soliris dose needed (Table 3). | FDA label |
| Missed dose | The Medication Guide tells the patient to call the healthcare provider right away. | FDA label |
| Vials | 300mg/30mL (10mg/mL) single-dose vial, one per carton, NDC 25682-001-01: 3 vials for 900mg, 4 for 1,200mg. Refrigerate at 2 to 8°C in the carton; one single period up to 3 days at room temperature not above 25°C is allowed. Do not freeze or shake. | FDA label |
Monitoring the Soliris label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Before day 1 | Meningococcal vaccination status against the ACIP complement inhibitor schedule; unresolved meningococcal infection | Required by the label and the REMS; prophylaxis prescription if urgent | FDA REMS page |
| Each infusion | Infusion-related reactions, including anaphylaxis or other hypersensitivity reactions | Observe at least 1 hour after completion; interrupt and give supportive measures for cardiovascular instability or respiratory compromise | FDA label |
| Any time | Meningococcal infection: fever, fever and a rash, fever with high heart rate, headache with nausea or vomiting, headache and a fever, headache with a stiff neck or stiff back, confusion, muscle aches with flu-like symptoms, eyes sensitive to light | Evaluate immediately; consider interrupting Soliris during treatment of serious meningococcal infection, weighing the risk of interruption in gMG | FDA label |
| Per ACIP | Meningococcal revaccination | Revaccinate considering the duration of therapy; vaccination does not eliminate risk | FDA label |
| Ongoing | Other Neisseria and encapsulated bacterial infections, including disseminated gonococcal infection; Aspergillus in immunocompromised and neutropenic patients | Use caution with any other systemic infection; counsel on gonorrhea prevention and regular testing for patients at risk | FDA label |
| Response | MG-ADL change at week 26 in Study ECU-MG-301: -4.2 on Soliris against -2.3 on placebo (p=0.006); QMG -4.6 against -1.6 (p=0.001) | The label says available data suggest clinical response is usually achieved by 12 weeks; it sets no stopping rule | FDA label |
| gMG trial safety | Musculoskeletal pain 15% against 8%, abdominal pain 8% against 5%, peripheral edema 8% against 5%, herpes simplex virus infections 8% against 2%, contusion 8% against 3%, pyrexia 7% against 3% | 62 on Soliris and 63 on placebo over 26 weeks; ages 19 to 79, 66% female. Extension study: headache 26%, nasopharyngitis 24%, diarrhea 15%, arthralgia 12%, upper respiratory tract infection 11%, nausea 10% | FDA label |
| Pediatric safety | Study ECU-MG-303, 26-week single arm, 11 patients 12 to 17 years: adverse reactions consistent with adults | Use at 6 to under 12 years rests on pharmacokinetic and safety data from other pediatric populations | FDA label |
| Adverse event reporting | Adverse events suggestive of meningococcal infection, with clinical outcomes | The REMS requires reporting to Alexion; the label lists 1-844-259-6783 | FDA REMS page |
| After stopping | Patient Safety Card carried for 3 months after the last dose; increased meningococcal risk persists for several weeks | Section 5.4 discontinuation monitoring is written for PNH (8 weeks) and aHUS (12 weeks), not gMG | FDA label |
Soliris drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Supplemental dose | Plasma exchange, plasmapheresis, fresh frozen plasma infusion and, in patients with gMG, concomitant IVIg reduce serum eculizumab and require a supplemental dose | FDA label |
| Monitor | Neonatal Fc receptor (FcRn) blockers may lower systemic exposure and reduce effectiveness; closely monitor for reduced effectiveness | FDA label |
| Anticoagulants | Treatment should not alter anticoagulant management | FDA label |
| Trial background therapy | Over 95% of patients in each group of Study ECU-MG-301 were receiving acetylcholinesterase inhibitors and 98% immunosuppressant therapies; about 50% had previously received at least 3 ISTs | FDA label |
| Pregnancy and lactation | Limited data from more than 300 pregnancies with live births have not suggested safety concerns but cannot exclude risk; data are insufficient on effects on the breastfed infant. The label lists no pregnancy registry. | FDA label |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Alexion OneSource
- 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
Questions prescribers' offices ask about Soliris
What is the Soliris dose for generalized myasthenia gravis?
900mg IV weekly for the first 4 weeks, 1,200mg for the fifth dose 1 week later, then 1,200mg every 2 weeks in adults, per section 2.3 of the label revised June 2026. Pediatric patients 6 years and older are dosed by weight under Table 1 in section 2.4, with 40kg and over on the adult regimen. Infuse over 35 minutes in adults and 1 to 4 hours in pediatric patients, and observe for at least 1 hour after completion.
Which vaccines are required before Soliris?
Meningococcal vaccines against serogroups A, C, W, Y and B, completed or updated at least 2 weeks before the first dose, per the boxed warning and section 2.1 of the label revised June 2026, on the ACIP schedule for complement inhibitor recipients. Section 5.3 notes higher pediatric risk and says to vaccinate against Streptococcus pneumoniae and Hib per ACIP, and section 17 and the Medication Guide direct those vaccines to children; the REMS covers meningococcal status only.
What supplemental Soliris dose goes with IVIg in gMG?
600mg per IVIg cycle when the most recent Soliris dose was 900mg or more, and 300mg when it was 600mg or less, per Table 3 of the label revised June 2026. With IVIg every 4 weeks or more often it is given at the same time as a scheduled Soliris dose; with IVIg less often than every 4 weeks it is given at the next scheduled dose after the last IVIg cycle. Acute rescue IVIg needs no supplemental dose.
What supplemental Soliris dose follows plasma exchange in gMG?
600mg within 60 minutes after each plasmapheresis or plasma exchange session when the most recent dose was 600mg or more, and 300mg when it was 300mg, per Table 2 of the label revised June 2026. Fresh frozen plasma takes 300mg given 60 minutes before each infusion. Table 2 applies to adult and pediatric patients with gMG.
What do insurers ask for to approve Soliris for gMG?
One example, Aetna CPB 0807, last reviewed November 10, 2026, asks for AChR antibody positivity, MGFA class II to IV, an MG-ADL total score of 5 or more, and a neurologist prescribing or consulted. It also asks for failure of at least 2 immunosuppressive therapies over 12 months, or 1 plus IVIG, or a documented reason to avoid them, and no concurrent complement inhibitor, FcRn blocker or Uplizna. The bulletin states no approval duration and covers Soliris, Bkemv and Epysqli.
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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, 2026-07-08.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Ultomiris and Soliris (eculizumab), BLA 125166 and BLA 761108, REMS last update 06/01/2026, FDA, 2026-06-01.
- Alexion OneSource™ | SOLIRIS | Financial Assistance, Alexion Pharmaceuticals, 2026-11-13.
- Alexion OneSource™ CoPay Program Terms and Conditions, US/ALL/1223 V1 12/2024, Alexion Pharmaceuticals, 2026-11-13.
- Alexion OneSource™ | SOLIRIS | About OneSource™, Alexion Pharmaceuticals, 2026-11-13.
- Alexion OneSource™ | SOLIRIS | Fill Out a Start Form, Alexion Pharmaceuticals, 2026-11-13.
- Alexion OneSource™ | SOLIRIS | Vaccination Support, Alexion Pharmaceuticals, 2026-11-13.
- Alexion Access Navigator | Soliris gMG, Alexion Pharmaceuticals, 2026-11-13.
- Eculizumab - Medical Clinical Policy Bulletins | Aetna, Number 0807, Aetna, 2026-11-10.
- 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, 2026-07-02.
- 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, 2026-07-06.
- BLA 761108/S-046 and BLA 125166/S-455 accelerated approval letter, Ultomiris IgA nephropathy and REMS modification, FDA, 2026-10-21.
- BLA 125166/S-454 supplement approval letter, Soliris labeling, FDA, 2026-06-30.
- BLA 125166/S-448 and BLA 761108/S-038 supplement approval letter, Soliris pediatric gMG and REMS modification, FDA, 2025-02-28.
- BLA 125166/S-422 supplement approval letter, Soliris for adults with gMG and REMS modification, FDA, 2017-10-23.
A reference drawn from the July 8, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 13, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.