ULTOMIRIS® safety information

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The safety of ULTOMIRIS® has been studied in more than 650 patients across 7 global clinical trials.*1

Its safety profile is also supported by over 4 years of post–marketing experience and real–world evidence across 3 additional indications.*1

Please refer to the ULTOMIRIS® Summary of Product Characteristics (SmPC) for further safety information

* 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.

There were no unexpected patterns in the incidence of TEAEs and no deaths reported in the ULTOMIRIS® group, excluding NMOSD relapses.2
Adapted from Pittock SJ, et al. Ann Neurol. 2023 93: 1053-1068.

* 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.2
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Adverse 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

aHUS, atypical haemolytic uraemic syndrome; EMA, European Medicines Agency; gMG, generalised myasthenia gravis; NMOSD, neuromyelitis optics spectrum disorder; PNH, paroxysmal nocturnal haemoglobinuria; SD, standard deviation; TEAE, treatment emergent adverse event; TESAE, treatment emergent serious adverse event.
ULTOMIRIS® Summary of Product Characteristics available at https://www.ema.europa.eu/en/documents/product-information/ultomiris-eparproduct-information_en.pdf Last accessed: October 2023. Pittock SJ, et al. Ravulizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. Ann Neurol. 2023;93(6):1053–1068.