Approved Risk Evaluation and Mitigation Strategies (REMS)

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Soliris (eculizumab)
BLA #125166
REMS last update: 07/12/2016

View the Soliris Prescribing Information and Medication Guide at DailyMed.
View Soliris's Regulatory Information at Drugs@FDA

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 be able to prescribe
  • Review the drug’s prescribing information.
  • Review the educational materials, including: Patient Safety Card, Prescriber Introductory Letter, Prescriber Safety Brochure Important Safety Information about Soliris , Patient Safety Brochure Important Safety Information about Soliris , and Dosing and Administration Guide.
  • Enroll in the REMS by completing and submitting the Prescriber Introductory Letter and Enrollment Form.
Before the first infusion
  • Counsel the patient using the Patient Safety Card and Medication Guide.
  • Provide the patient with the Patient Safety Card and Medication Guide.
  • Ensure the patient receives a meningococcal vaccine.
Before each infusion
  • Provide the patient with the Medication Guide.
At all times
  • Report serious life-threatening cases of meningococcal infection, including the patient’s clinical outcomes to the application holder.

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:


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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