Prescribing Information | Medication Guide | Important Safety Information  

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The purpose of the SOLIRIS REMS is to mitigate the occurrence and morbidity associated with
meningococcal infections by informing healthcare providers and patients about the:
  • Increased risk of meningococcal infections with Soliris
  • Early signs of invasive meningococcal infections, and
  • Need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections.
Soliris is available only through a restricted program under a Risk Evaluation and Mitigation
Strategy (REMS).
HCPs who prescribe Soliris must be specifically certified. Certification consists of review of
REMS educational materials and enrollment in the SOLIRIS REMS program.
Certification in the SOLIRIS REMS OneSource Safety Support Program includes the
following steps:
     
 
     
 
 
OR
Print and sign the Prescriber Introductory Letter and Enrollment Form
  • Mail the form to OneSource Safety Support Program, Alexion Pharmaceuticals, 100 College Street, New Haven, CT 06510; or,
  • Fax the form to Soliris OneSource Safety Program at 1-877-580-2596 (ALXN); or
  • Scan and email the form to OSSP@alxn.com
The Spanish versions of the Patient education material can be downloaded from below:
HCPs should provide their patients with a Soliris Patient Safety Card to carry with them at all times. This safety card contains important safety information about the risk of meningococcal infection that patients need to be aware of before they are given Soliris and during their treatment with Soliris. Remind them to show this card to any doctor involved in their treatment.
HCPs should explain to their patients that if they cannot reach their doctor, they should go to the emergency room immediately and show the emergency room staff the Soliris Patient Safety Card. Even if a patient stops using Soliris, they should keep their Soliris Patient Safety Card with them for 3 months after the last Soliris dose, since side effects may occur a long time after their last dose of Soliris.
To order a Soliris Patient Safety Information Card, contact OneSource at 1.888.SOLIRIS
(1.888.765.4747).
HCPs should report all suspected adverse events, including reports of meningococcal infection by contacting the OneSource Safety Support Program (Alexion Pharmaceuticals, Inc.) at 1.888.Soliris (1.888.765.4747); or reporting the information to the FDA MedWatch Reporting System by phone at 1.800.FDA.1088 (1.800.332.1088) or by mail using Form 3500 at http://www.fda.gov/MedWatch
 
 
 
 
 

 
 
Soliris is a trademark of Alexion Pharmaceuticals, Inc
©2016 Alexion Pharmaceuticals, Inc.. Last Updated xx/2016