SOLIRIS SAFETY IN NMOSD
Safety from the 3+ year PREVENT study
Adverse reactions reported in 5% or more of SOLIRIS® (eculizumab)-treated patients in the 3+ year PREVENT study and at a greater frequency than in placebo-treated patients1,2
| SOLIRIS (N=96) | Placebo (N=47) | |||
|---|---|---|---|---|
| N (%) | N (%) | |||
| Events/patients | 1295/88 | 617/45 | ||
| Blood and lymphatic system disorders | ||||
| Leukopenia | 5 (5) | 1 (2) | ||
| Lymphopenia | 5 (5) | 0 (0) | ||
| Eye disorders | ||||
| Cataract | 6 (6) | 2 (4) | ||
| Gastrointestinal disorders | ||||
| Diarrhea | 15 (16) | 7 (15) | ||
| Constipation | 9 (9) | 3 (6) | ||
| General disorders and administration site conditions | ||||
| Asthenia | 5 (5) | 1 (2) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 28 (29) | 6 (13) | ||
| Nasopharyngitis | 20 (21) | 9 (19) | ||
| Influenza | 11 (11) | 2 (4) | ||
| Pharyngitis | 10 (10) | 3 (6) | ||
| Bronchitis | 9 (9) | 3 (6) | ||
| Conjunctivitis | 9 (9) | 4 (9) | ||
| Cystitis | 8 (8) | 1 (2) | ||
| Hordeolum | 7 (7) | 0 (0) | ||
| Sinusitis | 6 (6) | 0 (0) | ||
| Cellulitis | 5 (5) | 1 (2) | ||
| Injury, poisoning, and procedural complications | ||||
| Contusion | 10 (10) | 2 (4) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 5 (5) | 1 (2) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 14 (15) | 6 (13) | ||
| Arthralgia | 11 (11) | 5 (11) | ||
| Musculoskeletal pain | 6 (6) | 0 (0) | ||
| Muscle spasms | 5 (5) | 2 (4) | ||
| Nervous system disorders | ||||
| Dizziness | 14 (15) | 6 (13) | ||
| Paraesthesia | 8 (8) | 3 (6) | ||
| Respiratory, thoracic, and mediastinal disorders | ||||
| Oropharyngeal pain | 7 (7) | 2 (4) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 5 (5) | 2 (4) | ||
SOLIRIS is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS)1
- You must enroll and complete certification in the SOLIRIS REMS program before you can prescribe SOLIRIS
- Visit www.solirisrems.com to complete the SOLIRIS REMS program or call 1-888-SOLIRIS (1-888-765-4747)
Learn more about the risk of 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 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.
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. Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(7):614-625.