ravulizumab
Ultomiris · ATC code L04AA43
- Key facts
- Active substance
- ravulizumab
- Drug class
- Immunosuppressive drug
- ATC code
- L04AA43
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Ultomiris 300 mg/3 mL concentrate for solution for infusion / Ultomiris 1 100 mg/11 mL concentrate for solution for infusion
- Marketing authorisation holder
- Alexion Europe SAS
- Information as of
- 2026-10-28
Key facts
Ravulizumab (Ultomiris) is a long-acting monoclonal antibody against complement protein C5 used to treat PNH, aHUS, generalised myasthenia gravis and NMOSD.
What it is used for
- Paroxysmal nocturnal haemoglobinuria (PNH) in adults and children weighing 10 kg or above: haemolysis with high disease activity, or clinically stable after at least 6 months of eculizumab.
- Atypical haemolytic uremic syndrome (aHUS) in adults and children weighing 10 kg or above, complement-inhibitor-naïve or after at least 3 months of eculizumab with response.
- Add-on therapy in adults with anti-AChR antibody-positive generalised myasthenia gravis; adults with anti-AQP4 antibody-positive NMOSD.
Dosing
- Adults ≥ 40 kg (intravenous): loading dose, then maintenance every 8 weeks starting 2 weeks later – ≥ 40 to < 60 kg 2,400 mg/3,000 mg; ≥ 60 to < 100 kg 2,700 mg/3,300 mg; ≥ 100 kg 3,000 mg/3,600 mg.
- Switching from eculizumab: give the loading dose at the time of the next scheduled eculizumab dose.
- Children with PNH or aHUS from 10 to < 40 kg: weight-based doses and intervals (see the full text); ≥ 40 kg as adults.
- Schedule may occasionally vary by ± 7 days (not for the first maintenance dose); home infusion by a qualified professional may be considered after good tolerance.
- Supplemental doses are needed with plasma exchange, plasmapheresis or IVIg (see the full text).
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Unresolved Neisseria meningitidis infection at treatment initiation.
- Not currently vaccinated against Neisseria meningitidis, unless given prophylactic antibiotics until 2 weeks after vaccination.
Important warnings
- Increased susceptibility to meningococcal infection/sepsis of any serogroup; vaccinate at least two weeks before starting, with vaccines against A, C, Y, W135 and B recommended.
- Monitor for early signs of meningococcal infection and treat immediately.
- After discontinuation in PNH and aHUS, monitor for haemolysis or thrombotic microangiopathy (see the full text).
Side effects
- Most common: headache (30.6%), upper respiratory tract infection (21.6%), nasopharyngitis (20.4%), diarrhoea (18.7%), pyrexia (17.7%), nausea (15%), arthralgia (14.4%), back pain (13.6%), fatigue (13.3%), abdominal pain (12.3%), dizziness (10.7%) and urinary tract infection (10.7%).
- Most serious: meningococcal infection (0.7%) including sepsis and meningitis, and disseminated gonococcal infection (0.2%).
Interactions
- May reduce the pharmacodynamic effects of rituximab.
- Chronic IVIg treatment may decrease ravulizumab concentrations.
Pregnancy and breastfeeding
- Effective contraception during and for 8 months after treatment; IgG crosses the placenta, so terminal complement inhibition in the foetus is possible.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
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)
- UltomirisAlexion Europe SAS · EMEA/H/C/004954
Source: European Medicines Agency (EMA), product information
Turkey
- UltomirisALEXİON 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
- Ultomiris
- Liechtenstein
- Ultomiris
- Norway
- Ultomiris
EMA – Article 57 product data (EU/EEA), 2026-10-29
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
- European Medicines Agency. Ultomiris – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/ultomiris-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L04AA.
Editorial: Medelix editorial team · last updated 2026-10-28 · 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.