Approved Risk Evaluation and Mitigation Strategies (REMS)

Soliris (eculizumab)

BLA #125166

REMS last update: 06/27/2019

Goals
Summary
REMS Materials
Update history

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	Review the drug’s Prescribing Information. Review the Patient Safety Card, Prescriber Safety Brochure, and Patient Safety Brochure. \| Patient Safety Card \| Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
Before treatment initiation at least 2 weeks prior to first dose	Assess the patient’s meningococcal vaccine status and immunize Provide the patient with a prescription for a two-week course of antibiotic prophylaxis if Soliris must be started less than 2 weeks after the patient was immunized. Counsel the patient using the Patient Safety Card and Patient Safety Brochure. Provide a copy of the materials to the patient. \| Patient Safety Card \|
During treatment	Assess the patient’s meningococcal vaccine status and immunize patients. Discontinue Soliris in patients who are being treated for serious meningococcal infections. Revaccinate patients according to the Advisory Committee on Immunization Practices recommendations.
At all times	Report cases of meningococcal infection, including the patient’s clinical outcomes to Alexion Pharmaceuticals, Inc.

Patients who are prescribed Soliris

Before treatment initiation, at least 2 weeks prior to the first dose	Get meningococcal vaccines as directed by your doctor. Take antibiotics as directed your doctor for two weeks after you get your vaccine if you have to start Soliris right away. Receive counseling from the prescriber using the Patient Safety Card and Patient Safety Brochure. \| Patient Safety Brochure \|
During treatment	Get meningococcal vaccines as directed by your doctor.
At all times	Inform the prescriber or get emergency care right away if you experience headache with nausea or vomiting; headache and a fever; headache with a stiff neck or stiff back; fever; fever and a rash; confusion; muscle aches with flu-like symptoms; eyes sensitive to light. Have the Patient Safety Card with you. \| 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
Patient Safety Brochure (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_Patient_Safety_Brochure.pdf
Patient Safety Card (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_Patient_Safety_Card.pdf
Prescriber Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_Prescriber_Enrollment_Form.pdf
Prescriber Safety Brochure (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_Prescriber_Safety_Brochure.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_REMS_Full.pdf
REMS Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2019_06_27_REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date	Summary of change
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: 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 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: 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 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.

Soliris (eculizumab) BLA #125166 REMS last update: 06/27/2019