Its safety profile is also supported by over 4 years of post–marketing experience and real–world evidence across 4 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
*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
At the end of the 2 years extension, the most common AEs were headache (23/58 [40%]) and diarrhoea (20/58 [35%]) in C5 inhibitor-naïve adults; and pyrexia (13/24 [54%]), diarrhoea (8/24 [33%]) and vomiting (8/24 [33%]) in C5 inhibitor-naïve paediatric patients4
Please refer to the ULTOMIRIS® Summary of Product Characteristics for further safety information.
*Septic shock (n=2 events) and cerebral haemorrhage (n=1 event).4 These were deemed to be the result of non-treatment-related serious AEs of secondary causes,5 and none of these deaths occurred during the period between the initial 26 weeks and 2 years.4,5
Please refer to the ULTOMIRIS® Summary of Product Characteristics for further safety information.
*Septic shock (n=2 events) and cerebral haemorrhage (n=1 event).4 These were deemed to be the result of non-treatment-related serious AEs of secondary causes,5 and none of these deaths occurred during the period between the initial 26 weeks and 2 years.4,5
Adverse Event Reporting
Please report any adverse events via your national reporting system. Adverse events can also be reported to Alexion Pharmaceuticals by contacting: https://contactazmedical.astrazeneca.com/
AE, adverse event