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SOLIRIS® (eculizumab) is indicated in adult patients with generalized Myasthenia Gravis (gMG).

SOLIRIS® was studied in clinical trials in patients who were anti-acetylcholine receptor (AChR) antibody positive and refractory, defined as failure of treatment with two or more immunosuppressive therapies (ISTs) either in combination or as monotherapy, or failed at least one IST and required chronic plasmapheresis, plasma exchange (PE), or intravenous immunoglobulin (IVIg) to control symptoms. Patients continued to receive standard therapy throughout the pivotal clinical trial.

SOLIRIS® should be administered by a qualified healthcare professional.

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Cases of serious or fatal meningococcal infections have been reported in patients treated with SOLIRIS®. Meningococcal infections may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current National Advisory Committee on Immunization (NACI) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • All patients must be vaccinated with meningococcal vaccines prior to, or at the time of, initiating SOLIRIS®, unless the risks of delaying SOLIRIS® therapy outweigh the risks of developing a meningococcal infection; revaccinate according to current medical guidelines for vaccine use.
  • All patients must be monitored for early signs of meningococcal infections, evaluated immediately if infection is suspected, and treated with antibiotics, if necessary.

Vaccination may not prevent all meningococcal infections.

Contraindications

Do not initiate SOLIRIS® therapy in patients:

  • With unresolved Neisseria meningitidis infection.
  • Who are not currently vaccinated against Neisseria meningitidis (unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination).
1. Conti-Fine BM, Milani M, Kaminski HJ. Myasthenia gravis: past, present, and future. J Clin Invest. 2006;116(11):2843-2854.
2. SOLIRIS® Product Monograph. Alexion Pharmaceuticals Inc. March 25, 2021.
3. Nowak RJ, et al. Concomitant immunosuppressive therapy use in eculizumab-treated adults with generalized myasthenia gravis during the REGAIN open-label extension study. Front Neurol. 2020;11:556104.