IMPORTANT SAFETY INFORMATION
The U.S. product label for Soliris includes a boxed warning:
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
See full prescribing information for complete boxed warning
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 (5.1).
- Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination
in patients with complement deficiencies.
- Immunize patients with a meningococcal vaccine 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 (5.1) for additional guidance on the management of meningococcal infection.)
- 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 (5.2). Enrollment in the Soliris REMS program and
additional information are available by telephone: 1-888-soliris (1-888-765-4747).
The most frequently reported adverse reactions in the PNH randomized trial (≥ 10% overall and greater than placebo)
are: headache, nasopharyngitis, back pain, and nausea.
The most frequently reported adverse reactions in aHUS single arm prospective trials (≥ 15% combined per patient incidence) are: hypertension, upper respiratory tract
infection, diarrhea, headache, anemia, vomiting, nausea, urinary tract infection, and leukopenia.