Notice Update to the notice relating to antibiotic prophylaxis and meningococcal vaccination of persons treated with eculizumab (Soliris® 300mg concentrate for solution for infusion)

Soliris (eculizumab) was granted a European Marketing authorisation (MA) in 2007 for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH), then, end 2011, this MA was granted an extension to its indicated use for the treatment of adults and children with atypical haemolytic uremic syndrome (aHUS). In patients treated with this molecule, measures to prevent invasive meningococcal infections (IMI) are needed. The French High Council of public health (HCSP) issued two notices in 2012 relating to the meningococcal ACWY conjugate vaccination and antibiotic prophylaxis of patients treated with Soliris®. The recent availability of the recombinant meningococcal B vaccine Bexsero® makes necessary an update to these notices.

The HCSP confirms the data in its notice of 12 July 2012 concerning the indicated uses of the quadrivalent ACYW135 meningococcal conjugate vaccine for persons treated with Soliris®. This vaccination must be given in accordance with the respective MAs of the two available tetravalent conjugate vaccines (from 1 year of age for Nimenrix®, 2 years for Menveo®).

It recommends that these patients are immunised with the (Bexsero®) vaccine from the age of 2 months in accordance with MA schedules, and that persons living in their close proximity also be vaccinated against ABCYW meningococci.

It considers, based on available data, that the value and rationale of the antibiotic options (penicillin V, macrolides in cases of allergy) are not called into question and that these antibiotics should continue to be recommended in adults and children. It recommends antibiotic prophylaxis for the duration of the Soliris® treatment, to be continued for sixty days after its end.

In any event, patients under Soliris® treatment must be informed of the benefits and risks of this treatment, of the signs and symptoms of meningococcal infection, as well as the procedures for obtaining immediate medical attention. In the event that an infection is suspected, appropriate antibiotic treatment must be implemented.