


healthcare professional
Its safety profile is also supported by over 4 years of post–marketing experience and real–world evidence across 3 additional indications.*1
* In generalised myasthenia gravis, paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS) and aquaporin–4 antibody–positive neuromyelitis optica spectrum disorder (AQP4 Ab+ NMOSD).1
† Dates of EMA approval across the different indications
- The most serious adverse reactions are meningococcal infection (0.7%), including meningococcal sepsis, encephalitis meningococcal, meningococcal infection and disseminated gonococcal infection (0.1%).1
- The most common adverse reactions with ravulizumab are headache (28.2%), upper respiratory tract infection (19.9%), nasopharyngitis (19.5%), diarrhoea (16.9%), pyrexia (16.4%), nausea (13.7%), arthralgia (13.2%), fatigue (13.1%), back pain (12.6%), abdominal pain (11.8%), and dizziness (10.1%).1
Please refer to the ULTOMIRIS® Summary of Product Characteristics for further safety information.

* In the ULTOMIRIS® group, excluding NMOSD relapses.2
† TEAEs and TESAEs were categorised as being related or unrelated to ravulizumab by treating physicians.2
‡ TEAEs reported as grade 1 were mapped to mild, grade 2 to moderate, and grades 3 to 5 to severe.2
§ Severe TEAEs were those that interrupted a patient’s usual daily activities and may have required systemic drug therapy or other treatment; severe events are usually incapacitating.2
The most common TEAEs (in > 10% of patients) were COVID-19 (24.1% of patients), headache (24.1%), back pain (12.1%), arthralgia (10.3%), and urinary tract infection (10.3%).2
Two patients developed meningococcal infections during treatment with ravulizumab, despite having received vaccination against Neisseria meningitidis serotypes A, C, W, Y, and B.2
Both patients were treated rapidly with antibiotics and intensive care, and both recovered fully with no sequelae. One patient withdrew from the study after recovering, whereas the other patient chose to continue receiving ravulizumab in the study.2Adverse Event Reporting
Please report any adverse reactions via your national reporting system. Adverse events should also be reported to Alexion pharmaceuticals by the following link: https://contactazmedical.astrazeneca.com