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U.S. Department of Health and Human Services

Safety

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Soliris (eculizumab)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009

 

Summary View

 

WARNINGS AND PRECAUTIONS

Serious Meningococcal Infections
  • Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.
  • In clinical studies among non-PNH patients, meningococcal meningitis occurred in one patient, who was unvaccinated.

ADVERSE REACTIONS

Postmarketing Experience
  • Cases of serious or fatal meningococcal infections have been reported.

 

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