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Soliris

DrugSoliris  (Eculizumab)  300 mg Injection

March 2013

Therapeutic Area - Monoclonal Antibody; Monoclonal Antibody, complement Inhibitor

Approval criteria

  • Patient has been vaccinated with meningococcal vaccine at least 2 weeks prior to receiving the first dose of Soliris AND
  • Patent is being treated for Paroxysmal Nocturnal Hemoglobinuria (PNH) OR
  • Patient is being treated for atypical hemolytic uremic syndrome (aHUS)

Background information

Soliris is indicated for rare ‘ultra-orphan’ diseases: Paroxysmal Nocturnal Hemoglobinuria (PNH) and Atypical hemolytic uremic syndrome (aHUS).

Soliris increased the risk of meningococcal infections. Patient must be vaccinated with meningococcal vaccine at least 2 weeks prior to receiving the first dose of Soliris. Revaccinate according to current medical guidelines for vaccine use.  Monitor patient for early signs of meningococcal infections. Evaluate immediately if an infection is suspected, and treat with antibiotics if necessary.

Soliris should not be administered in patients with either unresolved, serious Neisseria meningitides infection or who are currently not vaccinated against Neisseria menigitidis.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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