Understanding the Impact of gMG

Anti-AChR antibody-positive gMG affects everyone differently1

Adult patients with anti-AChR antibody-positive generalized myasthenia gravis (gMG) may not always experience adequate symptom control. Listen to the following 5 stories and learn how these adult patients could be right for SOLIRIS.

Meet Mr. It Is What It Is.

Learn more about this patient and his journey with anti-AChR antibody-positive gMG, including some of the symptoms he experiences:

DIFFICULTY CHEWING

He avoids having meals with family and friends.

SLURRED SPEECH

He schedules his meetings in the morning because his speech becomes slurred in the afternoon.

Watch the video to find out if he could be right for SOLIRIS.

This is the Woman on the Sidelines.

Learn more about this patient and her journey with anti-AChR antibody-positive gMG, including some of the symptoms she experiences:

MUSCLE FATIGUE

She requires frequent rest throughout the day, which cuts into the amount of time she spends with her family.

She jam-packs her mornings with daily activities before her fatigue sets in.

Watch the video to find out if she could be right for SOLIRIS.

Do you recognize the Forgotten Friend?

Learn more about this patient and his journey with anti-AChR antibody-positive gMG, including some of the symptoms he experiences:

SLURRED SPEECH

He doesn’t make plans with friends or family because they may not understand him.

DIFFICULTY CHEWING

He eats lunch alone at work because he’s embarrassed for people to see him.

Watch the video to find out if he could be right for SOLIRIS.

The Marooned Matriarch may look familiar.

Learn more about this patient and her journey with anti-AChR antibody-positive gMG, including some of the symptoms she experiences:

MUSCLE FATIGUE

She requires frequent rest throughout the day, which reduces the time she spends with family.

She doesn’t have the strength to comb her hair or dress herself.

Watch the video to find out if she could be right for SOLIRIS.

Do you know the Worn-Out Nurse?

Learn more about this patient and her journey with anti-AChR antibody-positive gMG, including some of the symptoms she experiences:

MUSCLE FATIGUE

She is constantly thinking about when she’ll have to rest during the day.

SLURRED SPEECH

She avoids talking to people because they may not be able to understand her.

Watch the video to find out if she could be right for SOLIRIS.

Adult patients with gMG may not always experience adequate symptom control1,2

Particularly those who present with:

Inadequate response to therapies

Comorbid conditions

restricting use of conventional therapies

Severe or intolerable adverse effects

from immunosuppressive or symptomatic therapy

Safety Profile of SOLIRIS

Learn about safety in REGAIN and the Open-label Extension Study.

See the data

SOLIRIS Study Design

Learn about REGAIN and the Open-label Extension Study.

See the Studies
Warning: Serious Meningococcal Infections
Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and 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

  • 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

The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis).

Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

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.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Use caution when administering Soliris to patients with any systemic infection.

Infusion-Related Reactions

Administration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. 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.

Indication

Generalized Myasthenia Gravis (gMG)

Soliris is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see full Prescribing Information for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections.

Warning: Serious Meningococcal Infections
Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and 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

  • 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

The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis).

Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

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.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Use caution when administering Soliris to patients with any systemic infection.

Infusion-Related Reactions

Administration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. 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.

Indication

Generalized Myasthenia Gravis (gMG)

Soliris is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see full Prescribing Information for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections.

References:

  1. Mantegazza R, et al. Ther Adv Neurol Disord. 2018;11:1756285617749134. doi:10.1177/1756285617749134
  2. Schneider-Gold C, et al. Ther Adv Neurol Disord. 2019;12:1-16. doi:10.1177/1756286419832242