See the possibility to realize the potential

Soliris is indicated for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive

In clinical trials, efficacy of Soliris was established in patients who had inadequate response to appropriate immunosuppressive treatments.1

Complement activity

Understand the role that complement activity plays in anti-AchR+ gMG.

Learn more

Early and sustained improvement in 2  assessments of gMG disease burden, MG-ADL, and QMG

MG-ADL
MG Activities of Daily Living
Primary endpoint

QMG
Quantitative MG (Disease Severity)
Key secondary endpoint

The efficacy of Soliris for treatment of gMG was established in gMG Study 1 (REGAIN).1,2

See the data

Clinical trial baseline characteristics

Learn more about REGAIN clinical trial patient characteristics at baseline.

Explore

Important Safety Information

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris.
Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • 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.
  • Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.

 

Indications and Usage

Generalized Myasthenia Gravis (gMG)

Soliris is indicated for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

 

Contraindications

Soliris is contraindicated in:

  • Patients with unresolved serious Neisseria meningitidis infection
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection

 

Warnings and Precautions

Other Infections

Soliris blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenza type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenza type b (Hib) infections according to ACIP guidelines. Use caution when administering Soliris to patients with any systemic infection.

 

Infusion Reactions

Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion reaction which required discontinuation of Soliris. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

 

Adverse Reactions

The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥10%) is: musculoskeletal pain.

 

Please see full prescribing information for Soliris, including boxed WARNING regarding serious meningococcal infection.

Abbreviations: anti-AchR+, acetylcholine receptor antibody positive; MG, myasthenia gravis; REGAIN, Eculizumab for Refractory Generalized Myasthenia Gravis.

References

  1. Soliris [prescribing information]. New Haven, CT: Alexion Pharmaceuticals Inc; 2017.
  2. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT01997229. Published November 18, 2013. Updated November 22, 2017. Accessed December 2, 2017.