Resources and tools for your practice

Download the tools below to learn more about anti-AchR+ gMG and Soliris

For Physicians

MG Instruments

MG Activities of Daily Living (MG-ADL)1-3

~10 minutes
A patient-reported, 8-item outcome measure that reflects ocular, bulbar, respiratory, and limb symptoms and their impact on function
 

Quantitative MG1,4

~30 minutes
A physician-reported, 13-item evaluation of ocular, facial, bulbar, gross motor, axial, and respiratory weakness
 

MG Composite1,5

<5 minutes
A physician- and patient-reported, 10-item weighted assessment of ocular, muscular, bulbar, and respiratory weakness
 

MG Quality of Life 15 revised (MG-QoL15r)6,7

~2 minutes
A patient-reported, 15-item assessment of patient well-being and independence
 

Assesment Tool Booklet

A collection of all 4 assessment instruments for your patients with Myasthenia Gravis (MG)

Download

Prescribing Resources

Soliris OneSource Brochure

A brochure outlining OneSource access and treatment support services for patients

Download

Prescribing Information for Soliris

Prescribing information interactive PDF

Download

For Your Patients

About Soliris

Soliris Patient Brochure

A brochure that can help your patients learn about anti-AchR+ gMG and how Soliris can work to treat it

Download

Soliris Patient Safety Information Card

The Patient Information Safety Card gives physicians and their patients important information they need to know before and during treatment with Soliris. A patient should keep this card with him/her at all times and show it to any doctor involved in his/her care.

Download

OneSource

Soliris OneSource Brochure

A brochure outlining OneSource access and treatment support services for patients

Download

OneSource Patient Authorization Form

A form patients need to fill out and complete in order to enroll in the OneSource program

Download

Formulario de Autorización del paciente OneSource

Un formulario que el paciente debe rellenar y completar para inscribirse en el programa OneSource

Descargue

Want to prescribe Soliris? Enroll in the Soliris REMS program.

Learn more

Questions about Soliris? Alexion Nurse Case Managers are here to help you and your patients.

Learn More

Greater improvements in activities of daily living (MG-ADL) were reported with Soliris vs placebo at 26 weeks.8

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; gMG, generalized myasthenia gravis; MG, myasthenia gravis; REMS, Risk Evaluation and Mitigation Strategy.

References

  1. Educational Materials. Myasthenia Gravis Foundation of America website. http://www.myasthenia.org/HealthProfessionals/EducationalMaterials.aspx. Accessed September 8, 2017.
  2. Muppidi S, Wolfe GI, Conaway M, Burns TM; MG Composite and MG-QOL15 Study Group. MG-ADL: still a relevant outcome measure. Muscle Nerve. 2011;44(5):727-731. doi:10.1002/mus.22140.
  3. Wolfe GI, Herbelin L, Nations SP, Foster B, Bryan WW, Barohn RJ. Myasthenia gravis activities of daily living profile. Neurology. 1999;52(7):1487-1489. doi:10.1212/WNL.52.7.1487.
  4. Howard JF Jr, Freimer M, O'Brien F, et al; for MG (Phase 2) Study Group. QMG and MG-ADL correlations: study of eculizumab treatment of myasthenia gravis. Muscle Nerve. 2017;56(2):328-330. doi:10.1002/mus.25529.
  5. Burns TM, Conaway MR, Sanders DB; for MG Composite and MG-QOL15 Study Group. The MG composite: a valid and reliable outcome measure for myasthenia gravis. Neurology. 2010;74(18):1434-1440. doi:10.1212/WNL.0b013e3181dc1b1e.
  6. Quality of Life. Myasthenia Gravis Foundation of America website. http://www.myasthenia.org/LivingwithMG/QualityofLife.aspx. Accessed September 21, 2017.
  7. Burns TM, Sadjadi R, Utsugisawa K, et al. International clinimetric evaluation of the MG-QOL15, resulting in slight revision and subsequent validation of the MG-QOL15r. Muscle Nerve. 2016;54(6):1015-1022. doi:10.1002/mus.25198.
  8. Soliris [prescribing information]. Boston, MA: Alexion Pharmaceuticals Inc; 2018.