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VACCINATIONS

Starting patients on Soliris® (eculizumab)

Before starting Soliris, immunize patients with meningococcal vaccinations.

Vaccinations are necessary before treatment with Soliris1

  • 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 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 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 patients immediately if an infection is suspected

2020 ACIP recommendations for meningococcal vaccinations in adult patients receiving Soliris2

2019 ACIP recommendations in patients receiving Soliris infographic
2019 ACIP recommendations in patients receiving Soliris infographic

aThe Centers for Disease Control and Prevention ACIP guidelines recommend all patients undergoing complement inhibition receive the MenACWY booster every 5 years.
bFor MenB-FHbp, if dose 2 was administered at least 6 months after dose 1, dose 3 is not needed.
cSpecial situations for MenB include those receiving a complement inhibitor (eg, eculizumab). 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.

Please refer to the most up-to-date ACIP recommendations for the most current and complete information for meningococcal vaccination in persons who are taking Soliris or have persistent complement component deficiencies.

 

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.1

Monitor patients for early signs and symptoms of meningococcal infection1

Advise patients to seek immediate medical attention if these signs or symptoms occur. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

Signs and symptoms of meningococcal infections include:

  • Headache with nausea or vomiting
  • Headache and fever
  • Headache with a stiff neck or stiff back
  • Fever
  • Fever and a rash
  • Confusion
  • Muscle aches with flu-like symptoms
  • Eyes sensitive to light
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IMPORTANT SAFETY INFORMATION & INDICATION FOR SOLIRIS® (eculizumab), INCLUDING BOXED WARNING

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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 Reactions

Administration of Soliris may result in infusion 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 reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.

INDICATION

Neuromyelitis Optica Spectrum Disorder (NMOSD)
Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

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

IMPORTANT SAFETY INFORMATION & INDICATION FOR SOLIRIS® (eculizumab), INCLUDING BOXED WARNING
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 Reactions

Administration of Soliris may result in infusion 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 reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.

INDICATION

Neuromyelitis Optica Spectrum Disorder (NMOSD)
Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

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

References
1. Soliris [package insert]. Boston, MA: Alexion Pharmaceuticals, Inc. 2. Freedman M, Kroger A, Hunter P, Ault KA: for the Advisory Committee on Immunization Practices. Recommended Adult Immunization Schedule, United States, 2020. Ann Intern Med. 2020;172(5):337-347.