Update on COVID-19

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

As the COVID-19 pandemic continues to evolve, so does the response from the healthcare community.

COVID-19 and Soliris

There is currently no evidence to support that the inhibition of complement using the monoclonal antibody (mAb), Soliris increases susceptibility to COVID-19 infection or its outcome.1

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.2,3

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.2,4

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-19.4 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.2

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.4 Please refer to the latest ACIP guidelines for updated vaccine recommendations.

Various societies and groups have been continuously analyzing data, providing advice, coordinating care, and testing new treatment options. While there are no FDA-approved therapies or drugs to treat, cure, or prevent COVID-19, there are several potential treatment options that are being explored.9

Unfortunately, some of the medications being tested to treat COVID-19 interfere with neuromuscular transmission and have been shown to exacerbate MG symptoms and even cause myasthenic crisis.10,11

Various medications have been mentioned in the news and social media as potential options for treating COVID-19, such as chloroquine and azithromycin. Physicians should be aware that these medications can potentially worsen MG. These treatments should only be used in patients with MG under strict medical supervision after weighing the risks and benefits to the individual patient.10-12

To see a more comprehensive list of medications to avoid or use with caution in MG, visit myasthenia.org.11

INDICATION & IMPORTANT SAFETY INFORMATION FOR SOLIRIS® (eculizumab)

INDICATION

Generalized Myasthenia Gravis (gMG)

Soliris is indicated for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

 

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris.
Meningococcal infection 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
Soliris is contraindicated in:

  • 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

See Boxed WARNING for additional information on serious meningococcal infections.

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis).

Vaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Revaccinate patients in accordance with ACIP recommendations, considering the duration of Soliris therapy.

Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If urgent Soliris therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide patients with 2 weeks of antibacterial drug prophylaxis.

The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving Soliris have not been established.

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. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

Because of the risk of meningococcal infections, Soliris is available only through a restricted program under a REMS. Under the Soliris REMS, prescribers must enroll in the program.

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.

Soliris blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. 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. In clinical trials, no patients experienced an infusion reaction that required discontinuation of Soliris. 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.

Please see full prescribing information for Soliris, including boxed WARNING regarding serious meningococcal infections.

 

References:

  1. Jacob, S. et al. Guidance for the management of myasthenia gravis (MG) and LambertEaton myasthenic syndrome (LEMS) during the COVID-19 pandemic. J Neuro Sci. 413:116803; 2020.
  2. Data on File; Global Drug Safety. Alexion Pharmaceuticals, 2020.
  3. Soliris (eculizumab) Periodic Benefit Risk Evaluation Report; Global Drug Safety. Alexion Pharmaceuticals 2019.
  4. SOLIRIS [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; June 2019.
  5. Olie KH et al. Am J Kidney Dis. 2005;45(1):e12–e15.
  6. Berner R et al. Pediatric Nephrology. 2002;17(3):190–192.
  7. Brodsky RA et al. Haematologica. E-pub ahead of print, Jan 16, 2020.
  8. Ueda T et al. Journal of Nippon Medical School. 2013;80(2):155–159.
  9. https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html. Accessed April 1, 2020.
  10. Mehrizi, M. et al. Medications and Myasthenia Gravis (A Reference for Health Care Professionals). Indiana University School of Medicine. 2012.
  11. https://myasthenia.org/What-is-MG/MG-Management/Cautionary-Drugs. Accessed April 1, 2020.
  12. Gautret P, Lagier JC, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020;105949.

 

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