Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS that have more than one drug product but are not Shared System REMS will not display the product name and ingredient properly on this website due to database limitations. Please refer to the REMS document for the correct product names.

Ultomiris and Soliris (eculizumab)

BLA #125166 BLA #761108

REMS last update: 03/22/2024

• View the Ultomiris and Soliris Prescribing Information at DailyMed
• View Ultomiris and Soliris's Regulatory Information at Drugs@FDA
• View the Ultomiris and Soliris Prescribing Information at DailyMed
• View Ultomiris and Soliris's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the ULTOMIRIS and SOLIRIS REMS is to mitigate the risk of serious meningococcal infections.

1. Patients are vaccinated against meningococcal infections caused by Neisseria meningitidis serogroups A, C, W, Y, and B prior to starting therapy according to the current Advisory Committee on Immunization Practices (ACIP) recommendations for patients receiving complement inhibitors and receive antibacterial drug prophylaxis if needed.
2. Patients are aware of early signs and symptoms of meningococcal infection and the need for immediate medical evaluation.
3. Prescribers are aware of early signs and symptoms of meningococcal infection and the need for immediate medical evaluation.

What do participants need to know?

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date	Summary of change
03/22/2024	Ultomiris and Soliris merged into a single program.
08/03/2022	Revised the Ultomiris REMS to reflect editorial change.
07/22/2022	Modified the Ultomiris REMS to change the REMS document to align with labeling and updated REMS materials to incorporate the revised logo capturing both intravenous and subcutaneous routes of administration.
04/27/2022	Modified the Ultomiris REMS to revise Prescriber Safety Brochure to include the indication for generalized myasthenia gravis. In addition, changes to all educational REMS materials were made to align with labeling.
11/23/2021	Modified the Ultomirs REMS to: Update the Prescriber Enrollment Form to remove the “Other (please specify):” from the Credentials Box and a change in font color from orange to blue to highlight the website address and email address. Change the Prescriber Safety Brochure to update the indication sentence for PNH to include pediatric (one month and older) patients. Update the copyright date on all REMS materials.
04/30/2020	Modified the Ultomiris REMS to make changes to the Prescriber Enrollment Form to include the prescriber specialty and reformat this form from two pages to one page.
04/07/2020	Modified the Soliris REMS to reflect revisions to the Prescriber Enrollment Form to include prescriber specialty.
10/18/2019	Modified the Ultomiris REMS to reflect changes to the Prescriber Safety Brochure including adding the new indication.
06/27/2019	Modified the Soliris REMS 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.
12/21/2018	Approval of the Ultomirs REMS
07/25/2018	Modified the Soliris REMS 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 the Soliris REMS 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 the Soliris REMS 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 the Soliris REMS to make an editorial change.
04/13/2016	Modified the Soliris REMS to: Add additional language regarding storage instructions in the REMS appended material, Dosing and Administration Guide, as reflected in the January 11, 2016 labeling. Update the sponsor’s address on the REMS document.
12/03/2015	Modified the Soliris REMS 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 the Soliris REMS 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 the Soliris REMS 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 the Soliris REMS to: Provide consistency with the revised package insert in the REMS document, Medication Guide, and appended REMS materials. Facilitate prescriber certification in the REMS document and the REMS materials
06/04/2010	Approval of the Soliris 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.