Treat Anti-AChR Antibody-positive gMG With Regular Dosing

Immunize patients with meningococcal vaccinations at least 2 weeks prior to treatment1

The 2021 Advisory Committee on Immunization Practices (ACIP) recommends the following meningococcal vaccination regimens for adult patients (aged ≥19 years) with persistent complement component deficiency or in patients receiving complement inhibitors, including patients receiving SOLIRIS1

Please refer to the most up-to-date ACIP recommendations for complete information on meningococcal vaccination in people with persistent complement component deficiencies and who are being treated with complement inhibitors, such as SOLIRIS.

Vaccinations are necessary before treatment with SOLIRIS2
  • The use of SOLIRIS increases a patient’s susceptibility to life-threatening and fatal meningococcal infections (septicemia and/or meningitis), which have occurred in patients treated with SOLIRIS
  • Comply with the most current ACIP recommendations for meningococcal vaccination in patients with complement deficiencies and patients receiving a complement inhibitor
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of SOLIRIS, unless the risks of delaying therapy outweigh the risk of developing a meningococcal infection
  • If urgent SOLIRIS therapy is indicated in an unvaccinated patient, initiate the vaccine regimen as soon as possible and provide 2 weeks of antibacterial drug prophylaxis
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections
    • Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate immediately if an infection is suspected

The Centers for Disease Control and Prevention ACIP guidelines recommend all patients undergoing complement inhibition receive the MenACWY booster every 5 years.

For MenB-FHbp, if dose 2 was administered at least 6 months after dose 1, dose 3 is not needed.

Special situations for MenB include those receiving a complement inhibitor (eg, SOLIRIS). ACIP recommends a MenB booster dose 1 year following completion of a MenB primary series followed by MenB booster doses every 2 to 3 years if risk remains.

 

Maintenance dosing assumes the patient has completed the 5-week induction phase.

Help manage anti-AChR antibody-positive gMG symptoms with regular dosing2

SOLIRIS should be administered within 2 days of these time points.

Only administer as an intravenous infusion.

Do not administer as an intravenous push or bolus injection.

SOLIRIS Administration2

35-MINUTE INFUSIONS

SOLIRIS intravenous infusion lasts approximately 35 minutes, plus 1 hour to monitor for an infusion reaction.

HOME INFUSIONS

May be available based on patient's insurance and location.

Select Important Safety Information
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.

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

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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. Recommended Adult Immunization Schedule for Ages 19 Years or Older. Centers for Disease Control and Prevention. February 11, 2021. Accessed June 11, 2021. https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf
  2. SOLIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.