In a safety analysis, fewer patients receiving Soliris experienced clinical deteriorationa and need for rescue therapy compared with placebo1

aCriteria for clinical deterioration: (1) patient experiencing an MG crisis, (2) patient experiencing exacerbations (defined as significant symptomatic worsening, ie, 2-point worsening or a score of 3 on any individual MG-ADL items other than double vision or eyelid droop), or (3) the treating physician believing the patient?s health is in jeopardy if rescue therapy is not administered.1

More than twice as many patients taking placebo experienced clinical deterioration or needed rescue therapy compared with those taking Soliris1

Fewer patients receiving Soliris experienced clinical deterioration and need for rescue therapy compared with placebo

No statistical testing of these data was conducted.
bBased on protocol criteria of clinical deterioration.1

Soliris responders had fewer exacerbations and less need for rescue therapy than nonresponders

cResponders were defined as patients who had at least a 3-point reduction in MG-ADL over 2 consecutive scheduled visits within 12 weeks of treatment with Soliris (note that for those who first responded at 12 weeks, the response was confirmed at 16 weeks).1
dDue to exacerbation. Rescue therapies received during REGAIN included high-dose corticosteroids, PLEX, and IVIg.1
eIn patients who require PLEX as rescue therapy, supplemental dosing of Soliris is required.2

In a safety analysis, fewer patients receiving Soliris experienced clinical deterioration and need for rescue compared with placebo.1

Learn how Soliris is dosed in adult patients with anti-AchR+ gMG.

See dosing

Explore the range of patient improvement in activities of daily living (MG-ADL) of patients in the REGAIN study.

See the data

INDICATION & IMPORTANT SAFETY INFORMATION FOR SOLIRIS® (eculizumab)

INDICATION

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.

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. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection)
  •  
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. 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.

 

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

 

Serious Meningococcal Infections

 

Risk and Prevention

 

See Boxed WARNING for additional information on serious meningococcal infections.

 

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis).

 

Vaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Revaccinate patients in accordance with ACIP recommendations, considering the duration of Soliris therapy.

 

Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If urgent Soliris therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide patients with 2 weeks of antibacterial drug prophylaxis.

 

The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving Soliris have not been established.

 

Vaccination reduces, but does not eliminate, the risk of meningococcal infections.

 

Closely monitor patients for early signs and symptoms of meningococcal infection, and evaluate patients immediately if an infection is suspected. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

 

REMS

Because of the risk of meningococcal infections, Soliris is available only through a restricted program under a REMS. Under the Soliris REMS, prescribers must enroll in the program.

 

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

 

Other Infections

Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.

 

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 influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae 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 that 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 infections.

Abbreviations: anti-AchR+, acetylcholine receptor antibody positive; IVIg, intravenous immunoglobulin; MG, myasthenia gravis; MG-ADL, myasthenia gravis activities of daily living; PLEX, plasma exchange; QMG, quantitative MG; REGAIN, Eculizumab for Refractory Generalized Myasthenia Gravis.

References

  1. Data on file. Alexion Pharmaceuticals, Inc.
  2. Soliris [prescribing information]. Boston, MA: Alexion Pharmaceuticals Inc; 2018.