Soliris (eculizumab)
An approved treatment for Paroxysmal Nocturnal Hemoglobinuria.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Eculizumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Eculizumab
- Brand name
- Soliris
- Development code
- h5G1.1
- Drug class
- Complement C5 inhibitor
- Manufacturer
- Alexion, AstraZeneca Rare Disease
- How it's taken
- IV infusion every 2 weeks after 5 weekly starting doses, about 35 minutes in adults.
The first drug the FDA approved for paroxysmal nocturnal hemoglobinuria (PNH), on March 16, 2007. Soliris blocks complement protein C5 to reduce the destruction of red blood cells inside blood vessels. It is given as an IV infusion every 2 weeks after 5 weekly starting doses, and the label gives PNH dosing for adults only. The biosimilars Bkemv and Epysqli carry the same PNH approval and dose.
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Where Eculizumab fits
The original C5 inhibitor for PNH, given every 2 weeks. Ravulizumab (Ultomiris), from the same company, blocks the same target and is given every 8 weeks for most adults. By Trial Friend's count from the 2 labels' schedules, an adult starting Soliris gets 28 infusions in the first year and about 26 a year after that, while an adult 20 kg or heavier starting Ultomiris gets 8 in the first year. No trial shows that one controls PNH better; the Ultomiris trials were designed to show it was not worse than Soliris.
How Eculizumab works
In PNH, red blood cells are missing protective proteins on their surface. The complement system, part of the immune defenses, then attacks them. The last step of that attack needs a protein called C5 to be split in 2, which builds a pore called the membrane attack complex that bursts red cells inside blood vessels (intravascular hemolysis)[1].
Eculizumab is a lab-made antibody that grabs C5 and stops it from being split, so the pore cannot form[1]. This protects red cells inside blood vessels. It does not block earlier steps of the complement cascade, so some red cells can still be coated with complement fragments and cleared by the spleen and liver (extravascular hemolysis). For people with that problem on Soliris, the FDA has approved danicopan (Voydeya) as an add-on pill[8].
Side effects and safety
- Other serious infections. Higher risk of infections from Streptococcus pneumoniae, Haemophilus influenzae and other Neisseria species, including gonorrhea. Aspergillus infections have occurred in people with very weak immune systems.
- Hemolysis after stopping. Monitoring for at least 8 weeks after the last dose to catch the return of red cell destruction.
- Blood clots. The effect of stopping blood thinners during Soliris has not been studied, so the label says anticoagulant care should not change.
- Infusion reactions. Allergic reactions, including anaphylaxis, can happen. The infusion can be slowed or stopped, and patients are watched for at least 1 hour afterward.
- Meningococcal vaccination at least 2 weeks before the first dose, with boosters per ACIP
- Carry the Patient Safety Card during treatment and for 3 months after the last dose
- Doses given on schedule or within 2 days of it
- Watch for hemolysis for at least 8 weeks after stopping
Soliris carries a boxed warning for serious meningococcal infections. It raises the risk of life-threatening or fatal infections caused by Neisseria meningitidis, a cause of meningitis and bloodstream infection, and these can happen even in people who have been vaccinated. Meningococcal vaccines for serogroups A, C, W, Y and B must be completed or updated at least 2 weeks before the first dose, unless waiting would be riskier than starting.
Soliris is available only through a restricted program called the ULTOMIRIS and SOLIRIS REMS, and patients carry a Patient Safety Card during treatment and for 3 months after the last dose[1].
In the main PNH trial, side effects more common on Soliris than placebo included headache (44% vs 27%), common cold symptoms called nasopharyngitis (23% vs 18%), back pain (19% vs 9%), nausea (16% vs 11%) and tiredness (12% vs 2%). Serious side effects happened in 9% of people on Soliris and 21% on placebo. In PNH studies, 2 patients had meningococcal sepsis even though both had been vaccinated[1].
The label also warns about other serious infections from bacteria such as Streptococcus pneumoniae and Haemophilus influenzae, and about infusion reactions, including allergic reactions. Stopping Soliris can bring hemolysis back, so the label calls for monitoring for at least 8 weeks after the last dose. It also says Soliris should not change how blood thinners are managed[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Eculizumab
Soliris is given by IV infusion in a clinic, hospital or home infusion setting. For PNH in adults 18 and older, the dose is 600mg once a week for the first 4 weeks, 900mg 1 week later for the fifth dose, then 900mg every 2 weeks. Each dose should be given on schedule or within 2 days of it[1].
In adults the infusion runs over 35 minutes. If it is slowed for a reaction, it should not go past 2 hours. Patients are watched for at least 1 hour after each infusion[1].
The biosimilars Bkemv and Epysqli use the same PNH dose and schedule, with their own REMS programs called BKEMV REMS and EPYSQLI REMS[3][4].
Availability and cost
Approved biosimilars: Bkemv, Epysqli
Help paying for Soliris
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients enrolled in OneSource may pay as little as $0 for SOLIRIS; Alexion says the program may help with some infusion costs. Not for Medicare, Medicaid or other federal or state plans.
For: private insurance · source - Insurance and case manager help
OneSource provides help navigating health insurance, treatment education, and a local Patient Education Manager.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: If you have Medicare, Medicaid or other government insurance, OneSource says it can connect you to third-party resources that may help. OneSource also offers vaccination support. The biosimilars Bkemv and Epysqli have their own makers' programs, not covered here.
- From a charity · NORD RareCarePNH Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting new applications and re-enrollments for next year” - From a charity · NORD RareCarePNH Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting new applications and re-enrollments for next year” - From a charity · NORD RareCareParoxysmal Nocturnal Hemoglobinuria (PNH) Emergency Relief fundOpen
Pays for: Emergency relief.
The foundation says: “Accepting Applications” - From a charity · The Assistance FundParoxysmal Nocturnal Hemoglobinuria (PNH) fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
- From a charity · TotalAssist (formerly PAN Foundation)Paroxysmal Nocturnal Hemoglobinuria fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $9,500 per year. Requires health insurance (any kind).
- From a charity · Aplastic Anemia & MDS International FoundationPNH Patient Travel Assistance Fund fundApply directly
Pays for: Travel to a PNH specialist or second opinion (patient plus one companion), up to $800 per year.
The foundation says: “Status not shown on page”
Every program and charity fund for Paroxysmal Nocturnal Hemoglobinuria →
Access and eligibility
The PNH approval covers patients with PNH, and the label gives PNH dosing for adults 18 and older. The label says safety and effectiveness in children with PNH have not been established. Soliris cannot be started during an unresolved serious meningococcal infection.
Source: Alexion OneSource, Soliris financial assistance
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
PNH Study 1 (NCT00122330) was a 26-week, double-blind trial that randomly assigned 87 adults who needed frequent transfusions to Soliris (43) or placebo (44). At the end, 49% on Soliris kept their hemoglobin stable with no transfusions against 0% on placebo, and 51% avoided transfusion entirely against 0%. The median number of red blood cell units transfused was 0 on Soliris and 10 on placebo. LDH, a blood marker of red cell destruction, fell to a median of 239U/L on Soliris and stayed at 2,167U/L on placebo[1].
A second, 52-week single-arm study (PNH Study 2) treated 97 patients, and an extension study followed 187 patients for 10 to 54 months. The label says the drop in red cell destruction held over that time[1].
Development history
Alexion Pharmaceuticals developed eculizumab, and the FDA approved Soliris for PNH on March 16, 2007, its first approval[2]. Later approvals added atypical hemolytic uremic syndrome, generalized myasthenia gravis and, on June 27, 2019, anti-AQP4 antibody positive neuromyelitis optica spectrum disorder[2]. AstraZeneca acquired Alexion in 2021.
The FDA approved 2 eculizumab biosimilars that include PNH: Bkemv (eculizumab-aeeb, Amgen) on May 28, 2024 and Epysqli (eculizumab-aagh) on July 19, 2024[5][6]. Alexion's longer-acting C5 inhibitor, ravulizumab (Ultomiris), was approved for PNH in December 2018[7].
Explore Paroxysmal Nocturnal Hemoglobinuria trials
Other Paroxysmal Nocturnal Hemoglobinuria treatments
PNH is treated with complement inhibitors. The C5 inhibitors eculizumab (Soliris and its biosimilars Bkemv and Epysqli), ravulizumab (Ultomiris) and crovalimab (Piasky) block red cell destruction inside blood vessels. Pegcetacoplan (Empaveli), which binds C3, and iptacopan (Fabhalta), a factor B inhibitor pill, act earlier in the complement cascade. Danicopan (Voydeya) is an add-on pill for extravascular hemolysis in people who stay on eculizumab or ravulizumab.
Common questions about Eculizumab
▸What is Eculizumab (Soliris)?
The first drug the FDA approved for paroxysmal nocturnal hemoglobinuria (PNH), on March 16, 2007. Soliris blocks complement protein C5 to reduce the destruction of red blood cells inside blood vessels. It is given as an IV infusion every 2 weeks after 5 weekly starting doses, and the label gives PNH dosing for adults only. The biosimilars Bkemv and Epysqli carry the same PNH approval and dose.
▸How does Eculizumab work?
In PNH, red blood cells are missing protective proteins on their surface. The complement system, part of the immune defenses, then attacks them. The last step of that attack needs a protein called C5 to be split in 2, which builds a pore called the membrane attack complex that bursts red cells inside blood vessels (intravascular hemolysis)[1].
Eculizumab is a lab-made antibody that grabs C5 and stops it from being split, so the pore cannot form[1]. This protects red cells inside blood vessels. It does not block earlier steps of the complement cascade, so some red cells can still be coated with complement fragments and cleared by the spleen and liver (extravascular hemolysis). For people with that problem on Soliris, the FDA has approved danicopan (Voydeya) as an add-on pill[8].
▸What are the side effects of Eculizumab?
Soliris carries a boxed warning for serious meningococcal infections. It raises the risk of life-threatening or fatal infections caused by Neisseria meningitidis, a cause of meningitis and bloodstream infection, and these can happen even in people who have been vaccinated. Meningococcal vaccines for serogroups A, C, W, Y and B must be completed or updated at least 2 weeks before the first dose, unless waiting would be riskier than starting. Soliris is available only through a restricted program called the ULTOMIRIS and SOLIRIS REMS, and patients carry a Patient Safety Card during treatment and for 3 months after the last dose[1].
In the main PNH trial, side effects more common on Soliris than placebo included headache (44% vs 27%), common cold symptoms called nasopharyngitis (23% vs 18%), back pain (19% vs 9%), nausea (16% vs 11%) and tiredness (12% vs 2%). Serious side effects happened in 9% of people on Soliris and 21% on placebo. In PNH studies, 2 patients had meningococcal sepsis even though both had been vaccinated[1].
The label also warns about other serious infections from bacteria such as Streptococcus pneumoniae and Haemophilus influenzae, and about infusion reactions, including allergic reactions. Stopping Soliris can bring hemolysis back, so the label calls for monitoring for at least 8 weeks after the last dose. It also says Soliris should not change how blood thinners are managed[1].
▸How is Eculizumab taken?
Soliris is given by IV infusion in a clinic, hospital or home infusion setting. For PNH in adults 18 and older, the dose is 600mg once a week for the first 4 weeks, 900mg 1 week later for the fifth dose, then 900mg every 2 weeks. Each dose should be given on schedule or within 2 days of it[1].
In adults the infusion runs over 35 minutes. If it is slowed for a reaction, it should not go past 2 hours. Patients are watched for at least 1 hour after each infusion[1].
The biosimilars Bkemv and Epysqli use the same PNH dose and schedule, with their own REMS programs called BKEMV REMS and EPYSQLI REMS[3][4].
▸Is Eculizumab FDA approved?
Yes, Eculizumab (Soliris) is FDA approved (2007) for the treatment of Paroxysmal Nocturnal Hemoglobinuria.
▸How often do you get Soliris infusions for PNH?
Every 2 weeks, after 5 weekly starting doses.
Starting doses: Adults get 600mg once a week for 4 weeks, then 900mg at week 5.
Ongoing doses: The dose is 900mg every 2 weeks, given on schedule or within 2 days of it.
Infusion time: About 35 minutes in adults, then at least 1 hour of observation.
Source: FDA label for Soliris, DailyMed, effective July 2026
▸Does Soliris stop the need for blood transfusions in PNH?
It did for about half the people in its main trial.
Trial result: Over 26 weeks, 51% of people on Soliris needed no transfusion against 0% on placebo, and the median number of units transfused fell from 10 to 0.
Who was studied: The trial enrolled 87 adults who had needed at least 4 transfusions in the year before.
What it does not cover: Some people on a C5 inhibitor still have anemia from red cells cleared in the spleen and liver, which Soliris does not block.
Source: FDA label for Soliris, DailyMed, effective July 2026
▸Why do I need a meningitis vaccine before Soliris?
Blocking C5 weakens the body's defense against meningococcal bacteria, and the label carries a boxed warning for that risk.
Timing: Meningococcal vaccines for serogroups A, C, W, Y and B are completed or updated at least 2 weeks before the first dose, unless waiting would be riskier.
If treatment is urgent: Antibiotics are given and the vaccines follow as soon as possible.
Still at risk: Vaccines lower but do not remove the risk. Get emergency care for fever, headache with a stiff neck, a rash, confusion or eyes sensitive to light.
Safety card: Carry the Patient Safety Card during treatment and for 3 months after the last dose.
Source: FDA label for Soliris, DailyMed, effective July 2026
▸What are Bkemv and Epysqli?
They are FDA-approved biosimilars of Soliris, made by other companies, with the same PNH approval and dose.
Bkemv: Eculizumab-aeeb from Amgen, approved May 28, 2024.
Epysqli: Eculizumab-aagh, approved July 19, 2024 and distributed in the U.S. by Teva, according to its label.
What is the same: The PNH dose of 600mg weekly for 4 weeks, 900mg at week 5, then 900mg every 2 weeks, and the meningococcal boxed warning.
What differs: Each has its own REMS program, called BKEMV REMS and EPYSQLI REMS. Whether you get Soliris or a biosimilar usually depends on your insurer and pharmacy.
Source: Bkemv label, DailyMed; Epysqli label, DailyMed; Drugs@FDA
▸Can children with PNH take Soliris?
The label does not cover children with PNH.
What the label says: Safety and effectiveness of Soliris in children with PNH have not been established, and PNH dosing is given for ages 18 and older.
Approved options for children: Ultomiris is approved for PNH from 1 month of age, and Piasky from age 13 at 40 kg or more.
Source: FDA label for Soliris, DailyMed, effective July 2026; FDA label for Ultomiris, DailyMed
▸What happens if I stop Soliris?
Red cell destruction from PNH can come back, so stopping needs a plan with your hematologist.
Monitoring: The label calls for watching for hemolysis for at least 8 weeks after the last dose.
Warning signs: A drop in red blood cell or platelet counts, kidney problems, blood clots, confusion, trouble breathing or chest pain.
Switching: People moving to Ultomiris get its loading dose when the next Soliris dose would have been due.
Source: FDA label for Soliris, DailyMed; FDA label for Ultomiris, DailyMed
▸Is there copay help for Soliris?
Yes, for people with commercial insurance.
Copay program: Alexion says eligible commercially insured patients enrolled in OneSource may pay as little as $0, and the program may help with some infusion costs.
Not eligible: Medicare, Medicaid and other federal or state plans. OneSource says it can point those patients to third-party resources.
Contact: Alexion OneSource at 1-888-765-4747.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-07-08. SOLIRIS (eculizumab) injection, for intravenous use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722
- U.S. Food and Drug Administration. Drugs@FDA: SOLIRIS, BLA 125166, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125166
- U.S. National Library of Medicine, DailyMed · 2026-07-02. BKEMV (eculizumab-aeeb) injection, for intravenous use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=002f9748-b0e8-4b6e-a38b-56930a839491
- U.S. National Library of Medicine, DailyMed · 2026-07-06. EPYSQLI (eculizumab-aagh) injection, for intravenous use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1fa1aa80-1c59-44d4-9841-b6c52882651b
- U.S. Food and Drug Administration. Drugs@FDA: BKEMV, BLA 761333, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761333
- U.S. Food and Drug Administration. Drugs@FDA: EPYSQLI, BLA 761340, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761340
- U.S. Food and Drug Administration. Drugs@FDA: ULTOMIRIS, BLA 761108, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761108
- U.S. National Library of Medicine, DailyMed. VOYDEYA (danicopan) tablets, for oral use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab8d1cbd-a28b-4d49-82ab-5c7460719ac7
- ClinicalTrials.gov. Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients. https://clinicaltrials.gov/study/NCT00122330
- Alexion, AstraZeneca Rare Disease. Alexion OneSource: Soliris financial assistance. https://alexiononesource.com/soliris/financial-assistance