Eculizumab Injection
Eculizumab injection is a complement inhibitor used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Eculizumab (Soliris) carries a serious boxed warning about life-threatening meningococcal infections. Because this drug blocks a key part of your immune defense, it significantly raises your risk of infection by Neisseria meningitidis — bacteria that can cause fatal blood poisoning (sepsis) or meningitis (infection around the brain). These infections can turn deadly within hours. This risk exists even in patients who have been vaccinated. You must receive meningococcal vaccines covering serogroups A, C, W, Y, and B at least 2 weeks before your first dose, unless starting treatment urgently. If urgent treatment is needed before vaccination is complete, your doctor will prescribe preventive antibiotics. Watch for warning signs — sudden fever, severe headache, stiff neck, sensitivity to light, or confusion — and seek emergency care immediately if they occur. Because of this risk, Soliris is only dispensed through a special safety program called the ULTOMIRIS and SOLIRIS REMS.
📖 Eculizumab Injection: Patient Information Guide
A plain-language walkthrough of Eculizumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Eculizumab injection is approved to treat four serious conditions involving an overactive complement immune system.
- Paroxysmal nocturnal hemoglobinuria (PNH): Soliris reduces the destruction of red blood cells inside blood vessels (intravascular hemolysis) in patients of all ages. Safety and effectiveness in pediatric PNH patients have not been established.
- Atypical hemolytic uremic syndrome (aHUS): Soliris stops complement-driven damage to small blood vessels (thrombotic microangiopathy) in adults and children as young as 2 months. It is NOT approved for hemolytic uremic syndrome caused by Shiga toxin-producing E. coli (STEC-HUS).
- Generalized myasthenia gravis (gMG): Soliris is approved for adults and children 6 years and older who test positive for anti-acetylcholine receptor (AChR) antibodies. It is not established for gMG in children under 6.
- Neuromyelitis optica spectrum disorder (NMOSD): Soliris is approved for adults who test positive for anti-aquaporin-4 (AQP4) antibodies. Safety and effectiveness in pediatric NMOSD patients have not been established.
⚙️How it works▾
Eculizumab is a monoclonal antibody that precisely targets and binds to complement protein C5 — a key trigger in your immune system's complement cascade. By blocking C5, it stops the production of a destructive protein complex called C5b-9 (also known as the membrane attack complex). In PNH, this prevents the immune system from punching holes in red blood cells and destroying them. In aHUS, it prevents the cascade from triggering dangerous micro-clots in blood vessels. In gMG and NMOSD, the exact pathway is not fully known, but it is believed to reduce immune-driven damage at the neuromuscular junction and in the central nervous system, respectively.
💊How it's taken▾
Eculizumab injection is given exclusively as an intravenous (IV) infusion at a clinic or infusion center — it cannot be self-administered at home. The general pattern starts with weekly infusions to build up levels, followed by maintenance infusions every two weeks. In adults, each infusion takes about 35 minutes; in children, infusions run 1 to 4 hours depending on body weight.
- Adult dosing schedules differ slightly depending on whether you are being treated for PNH versus aHUS, gMG, or NMOSD — your prescriber will set your exact plan.
- Pediatric dosing for aHUS and gMG is based on body weight.
- Extra doses are required if you also undergo plasma exchange, plasmapheresis, fresh frozen plasma infusion, or — for myasthenia gravis — IVIg treatment.
- Do not miss or delay doses without talking to your doctor first, as this can allow the underlying condition to return quickly.
🤒Side effects — in detail▾
The most common side effects vary somewhat by condition but generally include:
- Headache
- Nasopharyngitis (cold-like symptoms)
- Back pain
- Nausea and/or diarrhea
- Upper respiratory infections
- Fatigue
- Peripheral edema (swelling in the legs or feet)
- Musculoskeletal (muscle and joint) pain
Serious reactions to watch for include signs of meningococcal infection (sudden fever, severe headache, stiff neck, light sensitivity, confusion), signs of an infusion reaction (chest tightness, trouble breathing, dizziness), and signs that your underlying condition is worsening after a missed dose or after stopping treatment. Seek medical care immediately for any of these.
⚠️Warnings & precautions▾
- Meningococcal infection (most critical): Eculizumab disables a key immune defense, making life-threatening bacterial infections — especially meningococcal meningitis and sepsis — a real risk. This can happen even in vaccinated patients. Vaccination before starting is required, and you must carry a Patient Safety Card at all times during and for 3 months after treatment. Eculizumab is only dispensed through the ULTOMIRIS and SOLIRIS REMS restricted program because of this risk.
- Other serious infections: The drug also raises susceptibility to infections from Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae. Children are especially vulnerable to pneumococcal and Hib infections and should receive appropriate vaccines.
- Stopping treatment: Stopping eculizumab suddenly without medical supervision can cause the underlying disease to rebound rapidly — including red blood cell destruction in PNH and dangerous clotting in aHUS. Monitoring for at least 8 weeks (PNH) or 12 weeks (aHUS) after stopping is recommended.
- Infusion reactions: Allergic reactions, including anaphylaxis, can occur during infusion. You will be monitored for at least one hour after each infusion.
🔀What it interacts with▾
A few treatments can interact with eculizumab by reducing the amount of drug in your bloodstream:
- Plasma exchange or plasmapheresis: These procedures physically remove eculizumab from the blood, requiring supplemental doses immediately after each session.
- Fresh frozen plasma infusion: Also reduces eculizumab levels; a supplemental dose is given before each infusion.
- Intravenous immunoglobulin (IVIg): Used in myasthenia gravis management, IVIg can lower eculizumab levels; supplemental doses may be needed depending on the IVIg frequency and your current eculizumab dose.
- Neonatal Fc receptor (FcRn) blockers: This newer drug class may lower eculizumab levels and reduce its effectiveness — your doctor will monitor you carefully if both are used together.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active meningococcal infection: Eculizumab cannot be started if you currently have an unresolved serious Neisseria meningitidis infection.
- Vaccination requirement: You must be up to date with meningococcal vaccines (serogroups A, C, W, Y, and B) at least 2 weeks before your first dose. If treatment is urgent, preventive antibiotics are prescribed in the meantime.
- Other infections: Tell your doctor about any active infections before starting; use caution with any systemic illness during treatment.
- Pregnancy: Limited human data have not identified specific risks, but untreated PNH and aHUS in pregnancy carry serious risks for both mother and baby. Discuss benefits and risks with your doctor.
- Breastfeeding: It is not known whether eculizumab passes into breast milk in meaningful amounts. Discuss the risks and benefits with your doctor before breastfeeding.
- Children: Approved for aHUS (ages 2 months and older) and gMG (ages 6 and older). Not established for PNH or NMOSD in pediatric patients. Not approved for gMG in children under 6.
- Older adults (65+): Can use eculizumab, but clinical experience is limited — your doctor will monitor you closely.
- Kidney impairment: Kidney function does not significantly affect how eculizumab behaves in the body; no dose adjustment is needed based on renal function alone.
📡Pharmacodynamics — effects in the body▾
Eculizumab works by achieving complete blockade of the terminal complement system. In studies, blood levels of free complement protein C5 below 0.5 mcg/mL were associated with full suppression of this immune activity. In PNH, treatment rapidly reduced a marker of red blood cell destruction (LDH — lactate dehydrogenase) from very high levels down toward the normal range within the first week, with the effect maintained through at least a year of therapy.
🔬Pharmacokinetics — how your body processes it▾
Eculizumab is given intravenously, so it enters the bloodstream directly. Steady-state blood levels — where the amount going in equals the amount cleared — are typically reached within about 4 weeks of starting treatment. The drug has a long half-life ranging from roughly 6 to 37 days, meaning it stays in the body for an extended period. Plasma exchange or plasmapheresis clears eculizumab from the body about six times faster than normal, which is why supplemental doses are required after those procedures. Age, sex, race, and kidney function do not meaningfully affect how the body handles eculizumab.
📦How to store it▾
Store SOLIRIS vials refrigerated at 2°-8° C (36°-46° F) in the original carton to protect from light until time of use. stored in the original carton at controlled room temperature (not more than 25° C/77° F) for only a single period up to 3 days. of diluted solutions of SOLIRIS.
📄 Written from Eculizumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Eculizumab Injection
53 supplements and herbal products have documented interactions with Eculizumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 52
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Eculizumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I need to get vaccinated before starting this medication? ▾
What should I do if I miss an infusion appointment? ▾
Is it safe to take this medication while pregnant? ▾
What are the most common side effects I should expect? ▾
I'm also receiving plasma exchange for my condition. Does that affect how this medication works? ▾
Can my child receive this medication? ▾
Is Eculizumab Injection available over the counter? ▾
When was Eculizumab Injection first available? ▾
Who makes Eculizumab Injection? ▾
💬 Answers drafted from Eculizumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Eculizumab Injection comes
Eculizumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Soliris is used intravenously to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce red blood cell destruction (hemolysis)
- Soliris is used intravenously to treat atypical hemolytic uremic syndrome (aHUS) in adults and children, to stop complement-driven blood vessel damage
- Soliris is used intravenously to treat generalized myasthenia gravis (gMG) in adults and children 6 years and older who are AChR antibody positive
- Soliris is used intravenously to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are AQP4 antibody positive
- Soliris is given only as an intravenous infusion — never as a push or bolus injection — by a trained healthcare professional
- Soliris infusions are administered over approximately 35 minutes in adults and over 1 to 4 hours in pediatric patients
- Soliris is typically given weekly at the start of treatment, then every 2 weeks for maintenance; pediatric dosing is weight-based
- Soliris requires supplemental doses if you also receive plasma exchange, plasmapheresis, fresh frozen plasma infusion, or IVIg (for gMG)
📊 Eculizumab Injection across the U.S. market
How Eculizumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Eculizumab Injection is used
A general measure of how commonly Eculizumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Eculizumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Eculizumab Injection prescribed? Of the 1,596 medications we measure, Eculizumab Injection ranks #1,210 by Medicaid prescriptions — more than 24% of them.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Eculizumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 5 listed Eculizumab Injection NDCs with Medicaid activity.
🔍 Compare Eculizumab Injection products
A representative set of FDA-listed product records for Eculizumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 300 mg/30 mL | Intravenous | Alexion Pharmaceuticals Inc. × 3 listings | BLA | View NDC → |
| 300 mg/30 mL | — | Patheon Italia S.p.A | DRUG FOR FURTHER PROCESSING | View NDC → |
| 10 mg | — | Samsung BioLogics Co. LTD | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Eculizumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Eculizumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Eculizumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Eculizumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 591781 1 dose form · 3 strengths
-
Dose form (SCDF) Injection RxCUI 1655947In current FDA listingsClinical drug / strength (SCD) 30 ML eculizumab 10 MG/MLRxCUI 70038430 ML eculizumab-aagh 10 MG/MLRxCUI 270633830 ML eculizumab-aeeb 10 MG/MLRxCUI 2706351
Look up RxCUI 591781 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Eculizumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Eculizumab Injection belongs to the Complement Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Alexion Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.