COVID-19 Update

Updates on COVID-19 and Soliris

Update on COVID-19

Alexion understands our patients and health care providers may be concerned about the evolving COVID-19 situation and our products.


COVID-19 and Soliris

Soliris® (eculizumab) is a monoclonal antibody that specifically binds with high affinity to the complement protein C5, inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9.1 C5 inhibitors have no impact on antibody production. Soliris inhibits terminal complement and thus preserves the immunoregulatory and immunoprotective functions of the proximal components (proteins upstream of C5) of the complement cascade, thereby allowing for an immune response to viral infections.1,2

Based on Alexion’s understanding of the mechanism of action for Soliris, and the extensive postmarketing experience (cumulatively, over 10 years of commercial distribution, and over 50,000 patient-years of exposure), it does not appear that patients treated with Soliris are at higher risk of developing coronaviral infections or that the course of their infection will be different than in patients who have not received Soliris.3,4

Viral respiratory infections were observed during Alexion-sponsored clinical trials for Soliris. In the clinical trials, the viral respiratory infections were consistent with the types of infections common in the general population. The respiratory viral infections occurring in Soliris were not serious in nature, and all resolved without discontinuing Soliris treatment.1,3

Infection has been shown to amplify complement activity, which could have the potential to exacerbate a patient’s underlying condition in a complement-mediated disease.5-8 It is also important to note that Soliris patients are at increased risk for developing meningococcal infections, which have some of the same early symptoms as COVID-19.1 While meningococcal infection could present as classic meningitis with fever, headache and neck stiffness, please note the presentation can also present as meningococcal sepsis without meningitis.3

Patients should be reminded that if they develop a headache and fever or have muscle aches with flu-like symptoms (or any symptoms as described on the patient safety card), that they should call their doctor right away or seek emergency medical treatment, as these could be signs of a meningococcal infection that requires immediate medical attention. If patients cannot reach their doctor, immediately seek emergency medical treatment and show “Patient Safety Card” to emergency staff at the hospital.

Vaccination against Neisseria meningitidis is required before starting Soliris therapy.1 Please refer to the latest ACIP guidelines for updated vaccine recommendations.

Please see the full list of CDC recommendations for COVID-19 for information about populations that may be at higher risk of developing severe illness from COVID-19.


Background on B cells and B cell-depleting DMTs

As part of the immune system, B cells are responsible for protection against viruses and other pathogens.9 The use of B cell-depleting DMT may render an individual less capable of naturally mounting an effective immune response to viral infection. The use of these therapies may reduce the efficacy or affect the safety of certain vaccinations.10,11 To obtain more information about the potential effects of a particular B cell-depleting DMT on risks associated with COVID-19, please contact the manufacturer of the specific B cell-depleting DMT.


National Multiple Sclerosis Society guidance

In light of the recent outbreak of coronavirus (COVID-19), the National Multiple Sclerosis Society’s National Medical Advisory Committee published its recommendations regarding the use of disease-modifying therapies (DMTs) for people with multiple sclerosis (MS). One of the recommendations deals with the use of B cell-depleting DMTs.

For the MS guidance, please refer to https://www.nationalmssociety.org/What-you-need-to-know-about-Coronavirus-(COVID-19)/DMT-Guidelines-for-Coronavirus (COVID-19).

This may be concerning to physicians who treat patients with other autoimmune diseases, potentially including anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).

Coronavirus (COVID-19) home page: https://www.cdc.gov/coronavirus/2019-ncov/index.html

People who are higher risk of severe illness: https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/people-at-higher-risk.html

References:

  1. Soliris [package insert]. Boston, MA: Alexion Pharmaceuticals, Inc.
  2. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria. Nat Biotechnol. 2007;25(11):1256-1264.
  3. Data on file; Global Drug Safety. Alexion Pharmaceuticals, 2020.
  4. Soliris (eculizumab) Periodic Benefit Risk Evaluation Report; Global Drug Safety. Alexion Pharmaceuticals 2019
  5. Olie KH, Goodship TH, Verlaak R, et al. Posttransplantation cytomegalovirus-induced recurrence of atypical hemolytic uremic syndrome associated with a factor H mutation: successful treatment with intensive plasma exchanges and ganciclovir. Am J Kidney Dis. 2005;45(1):e12-e15.
  6. Berner R, Krause MF, Gordjani N, et al. Hemolytic uremic syndrome due to an altered factor H triggered by neonatal pertussis. Pediatr Nephrol. 2002;17(3):190-192.
  7. Brodsky RA, Peffault de Latour R, Rottinghaus ST, et al. Characterization of breakthrough hemolysis events observed in the phase 3 randomized studies of ravulizumab versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria [published online ahead of print January 16, 2020]. Haematologica. doi:10.3324/ haematol.2019.236877.
  8. Ueda T, Hayakawa J, Yamanishi M, Maeda M, Fukunaga Y. Efficacy of eculizumab in a patient with paroxysmal nocturnal hemoglobinuria requiring transfusions 14 years after a diagnosis in childhood. J Nippon Med Sch. 2013;80(2):155-159.
  9. Chaplin DD. Overview of the immune response. J Allergy Clin Immunol. 2010;125(2 suppl 2):S3-S23.
  10. National Multiple Sclerosis Society. https://www.nationalmssociety.org/What-you-need-to-know-about-Coronavirus-(COVID-19)/DMT-Guidelines-for-Coronavirus-(COVID-19)-and. Accessed March 26, 2020.
  11. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html. Accessed March 26, 2020.

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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.