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Eculizumab

Soliris · ATC code L04AA25

Key facts
Active substance
Eculizumab
Drug class
Immunosuppressive drug
ATC code
L04AA25
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Soliris 300 mg concentrate for solution for infusion
Marketing authorisation holder
Alexion Europe SAS
Information as of
2026-10-27

Key facts

Eculizumab is a monoclonal antibody that inhibits complement protein C5, used for PNH, aHUS, refractory generalized myasthenia gravis and NMOSD.

What it is used for

  • Paroxysmal nocturnal haemoglobinuria (PNH) in adults and children
  • Atypical haemolytic uremic syndrome (aHUS) in adults and children
  • Refractory generalized myasthenia gravis in AChR antibody-positive patients aged 6 years and above
  • Neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody-positive adults with a relapsing course

Dosing

  • Intravenous infusion over 25 – 45 minutes by a healthcare professional; home infusion possible if well tolerated
  • PNH (adults): 600 mg weekly for 4 weeks, then 900 mg in week 5 and every 14 ± 2 days
  • aHUS, gMG, NMOSD (adults): 900 mg weekly for 4 weeks, then 1,200 mg in week 5 and every 14 ± 2 days
  • Children ≥ 40 kg: adult dosing; below 40 kg a weight-based schedule (see full text)
  • Plasma exchange, plasmapheresis, plasma infusion or IVIg require a supplemental dose
  • gMG: discontinuation considered if no benefit by 12 weeks

Contraindications

  • Hypersensitivity to eculizumab, murine proteins or any excipient
  • Unresolved Neisseria meningitidis infection
  • Not vaccinated against Neisseria meningitidis, unless given prophylactic antibiotics until 2 weeks after vaccination

Important warnings

  • Increased susceptibility to meningococcal infection of any serogroup; vaccination at least 2 weeks before treatment
  • Vaccination and revaccination per national guidelines; vaccination may transiently worsen the underlying disease
  • Not expected to affect the aplastic component of anaemia in PNH
  • Name and batch number recorded for traceability

Side effects

  • Most common: headache, mostly in the initial phase
  • Most serious: meningococcal infection

Interactions

  • May reduce the pharmacodynamic effects of rituximab
  • IVIg and FcRn blockers may reduce effectiveness of eculizumab; close monitoring

Pregnancy and breastfeeding

  • Contraception during and for at least 5 months after the last dose should be considered
  • Limited data indicate no increased risk of foetal malformation or foetal-neonatal toxicity

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • Bekemv · biosimilarAmgen Europe B.V. · EMEA/H/C/005652
  • Epysqli · biosimilarSamsung Bioepis NL B.V. · EMEA/H/C/006036
  • SolirisAlexion Europe SAS · EMEA/H/C/000791

Source: European Medicines Agency (EMA), product information

Turkey

  • BekemvAMGEN İLAÇ TİC. LTD. ŞTİ. · 1 register entry
  • ElizariaSALUTE HC İLAÇ PAZARLAMA A.Ş. · 1 register entry
  • SolirisALEXİON İLAÇ TİC. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Bekemv, Soliris
Liechtenstein
Soliris
Norway
Bekemv, Soliris

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Soliris – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L04AA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.