Approved Risk Evaluation and Mitigation Strategies (REMS)

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Soliris (eculizumab)
BLA #125166
REMS last update: 01/13/2017



What is the purpose of the REMS?

The goals of the REMS are:

  1. To mitigate the occurrence and morbidity associated with meningococcal infections
  2. To educate Healthcare Professionals (HCPs) and Patients (or Caregivers, or Legal Guardians) regarding:
    1. the increased risk of meningococcal infections with Soliris® (eculizumab)
    2. the early signs of invasive meningococcal infections, and
    3. the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Soliris must

To become certified to prescribe
Before treatment initiation
  • Counsel the patient using the Patient Safety Card and Medication Guide.
    | Patient Safety Card |
  • Provide the patient with the Patient Safety Card and Medication Guide.
    | Patient Safety Card |
  • Ensure the patient receives a meningococcal vaccine.
During treatment; before each infusion
  • Provide the patient with the Medication Guide.
At all times
  • Report serious life-threatening causes of meningococcal infection, including the patient’s clinical outcomes to Alexion or FDA.

Patients who are prescribed Soliris

Before the first infusion
  • Review the Medication Guide and Patient Safety Card.
    | Patient Safety Card |
  • Get the meningococcal vaccine.
During treatment; before each infusion
  • Receive counseling from the prescriber using the Medication Guide and Patient Safety Card.
    | Patient Safety Card |

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Soliris REMS, see the DailyMed link(s).
Material Name Material Name Link
Dosing and Administration Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Dosing_And_Administration_Guide.pdf
Patient Safety Brochure, Important Safety Information about Soliris (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Patient_Safety_Brochure_Important_Safety_Information_For_Patients.pdf
Patient Safety Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Patient_Safety_Card.pdf
Prescriber Introductory Letter and Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Prescriber_Introductory_Letter_and_Enrollment_Form.pdf
Prescriber Safety Brochure, Important Safety Information about Soliris (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Prescriber_Safety_Brochure_Important_Safety_Information_For_the_Healthcare_Provider.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_Full.pdf
REMS Website Screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2017-01-13_REMS_Website_Screenshot.pdf

What updates have been made to the REMS?

Date Summary of change
01/13/2017 Modified to align with the changes to the prescribing information related to vaccination in patients receiving Soliris (eculizumab) in the Medication Guide, and REMS appended materials, including the Dosing and Administration Guide, Patient Safety Brochure, Important Safety Information about Soliris, Prescriber Safety Brochure, Important Safety Information about Soliris, Prescriber Introductory Letter and Enrollment Form, and the Soliris REMS website.
07/12/2016 Revised to make an editorial change.
04/13/2016 Modified to:

  1. Add additional language regarding storage instructions in the REMS appended material, Dosing and Administration Guide, as reflected in the January 11, 2016 labeling.
  2. Update the sponsor’s address on the REMS document.
12/03/2015 Modified to align with the prescriber information revisions regarding the level of fever needed to seek medical attention being approved in S-412, and to include contact information for reporting adverse events in the REMS, Medication Guide, and REMS appended materials, including the Patient Safety Card, the Dosing and Administration Guide, Patient Safety Brochure, Important Safety Information about Soliris, Prescriber Safety Brochure, Important Safety Information about Soliris, Prescriber Introductory Letter and Enrollment Form, and the Soliris REMS website.
10/10/2014 Modified to make editorial changes in the supporting REMS documents to align with the recently approved USPI, the addition of HCP enrollment on solirisrems.com and revisions to the Soliris (eculizumab) REMS website.
04/30/2014 Modified to change the timetable for submission of assessments from annually to every two years with the next report to be submitted by June 1, 2015, and a revised REMS assessment plan.
09/23/2011 Modified to:

  1. Provide consistency with the revised package insert in the REMS document, Medication Guide, and appended REMS materials.
  2. Facilitate prescriber certification in the REMS document and the REMS materials.
06/04/2010 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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