Prescribing guide
Soliris (eculizumab)Meningococcal vaccine requirements, REMS, loading and maintenance dosing, monitoring after discontinuation and prior authorization for PNHFor prescribers and their offices treating paroxysmal nocturnal hemoglobinuria (PNH): 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: patients with PNH, to reduce hemolysis; PNH dosing for 18 and older. Aetna CPB 0807 example, November 2026: GPI-AP deficiency by flow cytometry, clinical manifestations, no other complement inhibitor for PNH, hematologist. Label trial (PNH Study 1): at least 4 transfusions in the prior 12 months, at least 10% PNH cells, platelets at least 100,000/microliter.
Monitoring
Meningococcal infection at any time, at least 1 hour of observation after each infusion, revaccination per ACIP for the duration of therapy, and at least 8 weeks of monitoring for hemolysis after discontinuation; no scheduled on-treatment laboratory test is written into the label.
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 with no infusion-cost help for Massachusetts or Rhode Island residents, 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-paroxysmalBefore 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 | Treatment of patients with PNH to reduce hemolysis. Section 2.2 gives the dosage for patients 18 years of age and older; safety and effectiveness in pediatric patients with PNH 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 notes increased susceptibility to S. pneumoniae and H. influenzae, higher risk in children, and says to vaccinate against S. pneumoniae and Hib per ACIP; the sentence states no age limit, but it directly follows one about children, and section 17 and the Medication Guide address these vaccines for children. Not a REMS element. | 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 PNH (Indications 1.1) at the same dosage (2.2) with the same 8-week discontinuation monitoring (5.4). 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 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Diagnosis | PNH confirmed by detecting a deficiency of glycosylphosphatidylinositol-anchored proteins (GPI-APs), for example at least 5% PNH cells, at least 51% of GPI-AP deficient polymorphonuclear cells | Flow cytometry report with clone sizes and date | Aetna policy |
| Method | Flow cytometry is used to demonstrate GPI-AP deficiency | Laboratory method on the report | Aetna policy |
| Clinical manifestations | Member has and exhibits clinical manifestations of disease, for example LDH greater than 1.5 times ULN, thrombosis, renal dysfunction, pulmonary hypertension, dysphagia | LDH with reference range and date; clinic note | Aetna policy |
| Concomitant therapy | Not used in combination with another complement inhibitor for PNH (for example Empaveli, Fabhalta, PiaSky, Ultomiris); concomitant use with Voydeya is allowed | Current PNH medication list, with stop dates on a switch | Aetna policy |
| Prescriber | Prescribed by or in consultation with a hematologist | Specialty on the request | Aetna policy |
| Continuation | No evidence of unacceptable toxicity or disease progression; positive response, for example improvement in hemoglobin levels or normalization of LDH; still no other complement inhibitor for PNH | Hemoglobin and LDH before and on treatment | 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 is stated. | Check the plan's preferred product list before submitting | Aetna policy |
| Biosimilar labels | The Epysqli and Bkemv labels carry the PNH indication and the 600mg and 900mg PNH regimen | Current biosimilar label if the plan steers to one | Epysqli label |
| Appeal tools | Alexion Access Navigator posts a PNH sample letter of medical necessity, a PNH appeal letter, a prior authorization checklist for PNH, a peer-to-peer review guide, a PNH 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 |
|---|---|---|
| Days 1, 8, 15, 22 | 600mg IV weekly for the first 4 weeks. | FDA label |
| Day 29 | 900mg for the fifth dose, 1 week after the fourth. | FDA label |
| Every 2 weeks | 900mg every 2 weeks thereafter. Administer at the recommended dosage regimen time points, or within two days of these time points (2.2, cross-referenced to 5.4). | 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: 120mL final volume for 600mg, 180mL for 900mg. 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 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, plasma exchange, fresh frozen plasma | Section 7.1 says concomitant plasma exchange, plasmapheresis or fresh frozen plasma infusion can reduce serum eculizumab and requires a supplemental dose. The supplemental dosing table (2.5, Table 2) is written for aHUS, gMG and adult NMOSD; it does not name PNH. | FDA label |
| IVIg | Table 3 supplemental dosing is specified for patients with gMG. The label states no IVIg supplement for PNH. | 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: 2 vials for 600mg, 3 for 900mg. 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 PNH | 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 |
| Hemolysis markers | The label sets no on-treatment laboratory schedule. In the PNH trials hemolysis was monitored mainly by serum LDH; in PNH Study 1 mean LDH fell from 2,200U/L at baseline to 700U/L by week one and 327U/L at week 26 | Median LDH at end of study 239U/L on Soliris against 2,167U/L on placebo | FDA label |
| PNH Study 1 efficacy | Hemoglobin stabilization 49% against 0%, transfusion avoidance 51% against 0%, median packed RBC units transfused 0 against 10, over 26 weeks | 43 on Soliris and 44 on placebo; at least 4 transfusions in the prior 12 months, at least 10% PNH cells | FDA label |
| PNH trial safety | Headache 44% against 27%, nasopharyngitis 23% against 18%, back pain 19% against 9%, nausea 16% against 11%, fatigue 12% against 2%, cough 12% against 9%; serious adverse reactions 9% against 21% | 2 patients in PNH clinical studies had meningococcal sepsis; both had been vaccinated | 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 | Monitor for at least 8 weeks to detect hemolysis (5.4). Patient Safety Card carried for 3 months after the last dose; increased meningococcal risk persists for several weeks | Section 17: inform patients with PNH that serious hemolysis may develop when Soliris is discontinued | FDA label |
Soliris drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Plasma procedures | Plasma exchange, plasmapheresis and fresh frozen plasma infusion reduce serum eculizumab; the supplemental dosing table covers aHUS, gMG and adult NMOSD | FDA label |
| Monitor | Neonatal Fc receptor (FcRn) blockers may lower systemic exposure and reduce effectiveness; closely monitor for reduced effectiveness | FDA label |
| Anticoagulants | The effect of withdrawing anticoagulant therapy during treatment has not been established; treatment should not alter anticoagulant management. In PNH Study 2, 63% of patients were on anti-thrombotic agents | FDA label |
| Trial background therapy | In PNH Study 1, patients on anticoagulants and systemic corticosteroids at baseline continued them; 56% of the Soliris arm were on anticoagulants and 33% on steroids or immunosuppressants | FDA label |
| Pregnancy and lactation | Limited data from more than 300 pregnancies with live births have not suggested safety concerns but cannot exclude risk; untreated PNH in pregnancy carries maternal and fetal risks. 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 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.
- 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.
- 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.
- 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.
- 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. The clinic's infusion fee may then fall on you.
- 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
- 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
Questions prescribers' offices ask about Soliris
What is the Soliris dose for PNH?
Section 2.2 of the label effective July 8, 2026 gives 600mg IV weekly for the first 4 weeks, 900mg for the fifth dose 1 week later, then 900mg every 2 weeks. The dose is for patients 18 and older and is fixed, not weight-based. Give it at the recommended time points or within 2 days of them, infuse over 35 minutes, do not exceed 2 hours if slowed, 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 effective July 8, 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, a sentence that states no age limit but directly follows one about children, and section 17 and the Medication Guide address these vaccines for children; the REMS covers meningococcal status only.
Can Soliris start before the vaccines have had 2 weeks?
Yes, if urgent therapy is indicated and the patient is not up to date 2 weeks before the first dose, the label effective July 8, 2026 says to give antibacterial drug prophylaxis and meningococcal vaccines as soon as possible. The REMS requires the prescriber to write that prescription, and the label notes that optimal prophylaxis regimens and durations have not been studied.
How long are PNH patients monitored after stopping Soliris?
At least 8 weeks after discontinuation, to detect hemolysis, per section 5.4 of the label effective July 8, 2026. The Medication Guide lists a drop in red blood cell count, a drop in platelet count, kidney problems, blood clots, confusion, difficulty breathing and chest pain. The Patient Safety Card stays with the patient for 3 months after the last dose.
What do insurers ask for to approve Soliris for PNH?
One example, Aetna CPB 0807, last reviewed November 10, 2026, asks for 4 things: PNH confirmed by GPI-anchored protein deficiency, flow cytometry demonstrating it, clinical manifestations such as LDH above 1.5 times ULN or thrombosis, and no other complement inhibitor for PNH, with Voydeya allowed. A hematologist prescribes or is consulted. Continuation needs no unacceptable toxicity or progression and a positive response such as improved hemoglobin or normalized LDH. 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, 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 PNH, 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 (1.1) and Dosage and Administration (2.2) for PNH, Amgen, via openFDA, 2026-07-02.
- 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, 2026-07-06.
- BLA 125166/S-454 Supplement Approval letter, Soliris (eculizumab) injection, FDA, 2026-06-30.
- Drugs@FDA: FDA-Approved Drugs, Biologic License Application (BLA): 125166, SOLIRIS, FDA, 2026-11-13.
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.