Approved Risk Evaluation and Mitigation Strategies (REMS)
Soliris (eculizumab)
BLA #125166
REMS last update: 04/07/2020
What is the purpose of the REMS?
The goals of the REMS are:
- To mitigate the occurrence and morbidity associated with meningococcal infections
- To educate Healthcare Professionals (HCPs) and Patients regarding:
- the increased risk of meningococcal infections with Soliris
- the early signs of invasive meningococcal infections, and
- 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
Healthcare Providers who prescribe Soliris must:
To become certified to prescribe |
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Before treatment initiation at least 2 weeks prior to first dose |
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During treatment |
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At all times |
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Patients who are prescribed Soliris:
Before treatment initiation, at least 2 weeks prior to the first dose |
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During treatment |
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At all times |
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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 |
---|---|
Patient Safety Brochure (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Patient Safety_Brochure.pdf |
Patient Safety Card (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Patient_Safety_Card.pdf |
Prescriber Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Prescriber_Enrollment_Form.pdf |
Prescriber Safety Brochure (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Prescriber_Safety_Brochure.pdf |
REMS Program Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_REMS_Program_Website_Screenshots.pdf |
Soliris REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_REMS_Document.pdf |
Soliris REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_REMS_Full.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
04/07/2020 | Modified to reflect revisions to the Prescriber Enrollment Form to include prescriber specialty. |
06/27/2019 | Modified to make changes to the Prescriber Safety Brochure to align with labeling changes related to the new indication and to align with revised wording in the Indications and Usage section of labeling related to the generalized myasthenia gravis indication. |
07/25/2018 | Modified the REMS Program supporting document, Soliris REMS document, Prescriber Safety Brochure, REMS Dosing and Administration guide, and Prescriber Introductory Letter and Enrollment Form, and removal of the Medication Guide from the REMS. |
10/23/2017 | Modified to make editorial changes to the REMS document and changes to the REMS appended materials to align with labeling changes related to the new indication. |
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:
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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:
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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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