First FDA-approved Terminal Complement Inhibitor for Anti-AChR Antibody-positive gMG

SOLIRIS is the first terminal complement inhibitor approved by the FDA to treat adult patients with anti-AChR antibody-positive gMG1

SOLIRIS works by specifically binding to C5 and prevents generation of the membrane attack complex (MAC)

gMG Mechanism of Disease2

In adult patients with anti-AChR antibody-positive gMG, the complement system is activated by antibodies to AChR.2

Chronic complement activation leads to cleavage of C5 into C5a and C5b, which leads to inflammation and neuromuscular junction (NMJ) damage through the formation of the MAC (C5b-9).2

SOLIRIS Mechanism of Action2

SOLIRIS binds to C5, thereby inhibiting its cleavage to C5a and C5b and preventing the formation of the MAC.2

The precise mechanism by which SOLIRIS exerts its therapeutic effect in anti-AChR antibody-positive gMG is unknown but is presumed to involve reduction of MAC (C5b-9) deposition at the NMJ.3

Learn how SOLIRIS is thought to prevent the generation of MAC

SOLIRIS specifically binds to C5 to inhibit terminal complement activity3

Immunoprotective and immunoregulatory functions of the proximal complement pathway are preserved as SOLIRIS acts on the terminal pathway and specifically inhibits the cleavage of C5.4,5

The precise mechanism by which SOLIRIS exerts its therapeutic effect in anti-AChR antibody-positive gMG is unknown but is presumed to involve reduction of MAC (C5b-9) deposition at the NMJ.3

By binding to C5, SOLIRIS blocks its cleavage into C5a and C5b6

 
SELECT IMPORTANT SAFETY INFORMATION
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.

Please see additional Important Safety Information for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections, below.

SOLIRIS Clinical Data

Learn more about REGAIN and the Open-label Extension studies and their endpoints.

See the data

SOLIRIS Dosing Information

Learn about the dosing regimen and route of administration.

View dosing info
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. Data on file. Alexion Pharmaceuticals, Inc. 2016.
  2. Vissing J, et al. J Neurol. 2020;267(7):1991-2001. doi:10.1007/s00415-020-09770-y
  3. SOLIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  4. Rother RP, et al. Nat Biotechnol. 2007;25(11):1256-1264. doi:10.1038/nbt1344
  5. Sheridan D, et al. PLoS One. 2018;13(4):e0195909. doi:10.1371/journal.pone.0195909
  6. Howard JF Jr, et al. Lancet Neurol. 2017;16(12):976-986. doi:10.1016/S1474-4422(17)30369-1