The Centers for Disease Control and Prevention (CDC) is warning that side effects of the immunosuppressant medication Soliris may increase the risk of meningococcal infections by up to 2,000% despite vaccination.
Soliris (eculizumab) is a medication that prevents activity of the immune system. It is most commonly used to treat atypical hemolytic uremic syndrome and paroxysmal noctornal hemoglobinuria.
The drug already carries a Boxed Warning about the risk of meningococcal infections, which is the strongest warning the FDA can require on a medication.
The same label recommends that doctors “immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection.”
Now, the CDC is warning that meningococcal infections due to Soliris may not be preventable with a meningitis vaccine.
In this week’s Morbidity and Mortality Weekly Report (MMWR), the CDC indicates that meningococcal infections can occur in Soliris patients despite vaccination. There were 16 cases of meningococcal meningitis in Soliris patients in the U.S. between 2008 and 2016 — and most of those cases occurred in patients who were vaccinated.
According to the MMWR report:
“The majority of cases were caused by nongroupable Neisseria meningitidis and occurred in patients who had documentation of receipt of at least 1 dose of meningococcal vaccine before disease onset.”
The CDC noted that a growing number of doctors and health agencies worldwide are recommending that Soliris patients also take antibiotics for the duration of treatment to reduce the risk of bacterial infections.
The CDC is also now recommending this treatment regimen, but cautions that “neither vaccination nor antimicrobial prophylaxis can be expected to prevent meningococcal disease in eculizumab recipients.”