Risk Minimisation Materials for eculizumab (Bekemv)
Materials include a Physician’s Guide, discussing risk of severe infection and sepsis, especially meningococcal infection, signs and symptoms of severe infection, how to minimise this risk (vaccination requirements; antibiotic prophylaxis) and other serious adverse reactions.
Source:
Amgen
SPS commentary:
This biosimilar to Soliris is licensed for use in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.