FDA.reportPublic FDA data

Soliris - Alexion Pharmaceuticals Inc.

Manufacturer
Alexion Pharmaceuticals Inc.
Effective date
2025-06-27
Label type
Risk Evaluation & Mitigation Strategies
Version
5
Source
full-release
Hydrated at
2026-06-04 22:50:40

Label at a glance#

ProductSoliris
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Serious meningococcal infections
Application Numbers: BLA 761108 and BLA 125166
Application Holder: Alexion Pharmaceuticals, Inc.
Initial REMS approval: 06/2010
Most Recent REMS Update: 06/2025

II. REMS Goal

REMS GOALS

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.

III. REMS Requirements

REMS REQUIREMENTS

Alexion Pharmaceuticals, Inc. must ensure that healthcare providers, patients, healthcare settings, and pharmacies comply with the following requirements:

REMS PARTICIPANT REQUIREMENTS

1. Healthcare providers who prescribe ULTOMIRIS and/or SOLIRIS must:
To become certified to prescribe1. Review the drug's Prescribing Information.
2. Review the Healthcare Provider Safety Brochure, Patient Safety Card, and Patient Guide.
3. Enroll by completing and submitting the Prescriber Enrollment Form to the REMS.
Before treatment initiation4. Assess the patient for unresolved meningococcal infection.
5. For patients with an unresolved serious meningococcal infection: Not initiate ULTOMIRIS or SOLIRIS.
6. Assess the patient’s vaccination status for meningococcal serogroups A, C, W, Y, and B and vaccinate as needed according to the current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor.
7. For patients who are not up to date with meningococcal vaccines at least two weeks prior to initiation of treatment and who must start ULTOMIRIS or SOLIRIS urgently: Provide the patient with a prescription for antibacterial drug prophylaxis.
8. Counsel the patient using the Patient Safety Card and Patient Guide. Provide a copy of the materials to the patient.
9. Counsel the patient on the need to carry the Patient Safety Card.
During treatment10. Assess the patient for early signs and symptoms of meningococcal infection and evaluate immediately if infection is suspected.
11. Vaccinate patients as needed according to the current ACIP recommendations for meningococcal vaccinations for patients receiving a complement inhibitor.
At all times12. Report adverse events suggestive of meningococcal infection, including the patient’s clinical outcomes, to Alexion Pharmaceuticals, Inc.

REMS PARTICIPANT REQUIREMENTS

2. Patients who are prescribed ULTOMIRIS or SOLIRIS:
Before treatment initiation1. Get meningococcal vaccines for serogroups A, C, W, Y, and B as directed by your prescriber.
2. Take antibiotics as directed by your prescriber if you have to start ULTOMIRIS or SOLIRIS right away.
3. Receive counseling from your prescriber using the Patient Safety Card and Patient Guide.
4. Get the Patient Safety Card and Patient Guide from your prescriber.
During treatment5. Get additional meningococcal vaccines as directed by your prescriber.
At all times during treatment and for 3 months after the last SOLIRIS dose6. For SOLIRIS patients: Have the Patient Safety Card with you.
7. For SOLIRIS patients: Inform your prescriber or get emergency medical care right away if you experience any of the following: fever; fever and a rash; fever with high heart rate; headache with nausea or vomiting; headache and fever; headache with stiff neck or stiff back; confusion; eyes sensitive to light; muscle aches with flu-like symptoms.
At all times during treatment and for 8 months after the last ULTOMIRIS dose8. For ULTOMIRIS patients: Have the Patient Safety Card with you.
9. For ULTOMIRIS patients: Inform your prescriber or get emergency medical care right away if you experience any of the following: fever; fever and a rash; fever with high heart rate; headache with nausea or vomiting; headache and fever; headache with stiff neck or stiff back; confusion; eyes sensitive to light; muscle aches with flu-like symptoms.

REMS PARTICIPANT REQUIREMENTS

3. Healthcare settings and pharmacies that dispense ULTOMIRIS and/or SOLIRIS must:
To become certified to dispense1. Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the healthcare setting or pharmacy.
2. Have the Authorized Representative review the Healthcare Provider Safety Brochure.
3. Have the Authorized Representative enroll by completing and submitting the Healthcare Setting and Pharmacy Enrollment Form to the REMS.
4. Train all relevant staff involved in dispensing ULTOMIRIS and SOLIRIS using the Healthcare Provider Safety Brochure.
5. Establish processes and procedures to assess the patient’s vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B according to the current Advisory Committee on Immunization Practices (ACIP) recommendations including antibacterial drug prophylaxis, if needed, before treatment initiation and document the findings.
6. For patients who are not up to date with meningococcal vaccines when starting treatment: Establish processes and procedures to assess the patient’s vaccination status for up to date meningococcal vaccines including antibacterial drug prophylaxis, if needed, before dispensing prescriptions up to 6 months after the first dose and document the findings.
Before dispensing, first dose7. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
8. Assess the patient’s vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B including antibacterial drug prophylaxis, if needed, and document the findings through the processes and procedures established as a requirement of the REMS.
Before dispensing, up to 6 months after the first dose9. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
10. For patients who are not initially up to date with meningococcal vaccines when starting treatment: Assess the patient’s vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B including antibacterial drug prophylaxis, if needed, and document the findings through the processes and procedures established as a requirement of the REMS.
Before dispensing, 6 months after the first dose and thereafter11. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
To maintain certification to dispense12. If the Authorized Representative changes, have a new Authorized Representative enroll by completing and submitting the Healthcare Setting and Pharmacy Enrollment Form to the REMS.
At all times13. Report adverse events suggestive of meningococcal infections to Alexion Pharmaceuticals, Inc.
14. Not distribute, transfer, loan, or sell ULTOMIRIS or SOLIRIS, except to other certified healthcare settings or certified pharmacies.
15. Maintain records of staff’s completion of REMS training.
16. Maintain records that all processes and procedures are in place and are being followed.
17. Comply with audits carried out by Alexion Pharmaceuticals, Inc. or a third party acting on behalf of Alexion Pharmaceuticals, Inc., to ensure that all processes and procedures are in place and are being followed.

REMS APPLICANT REQUIREMENTS

Alexion Pharmaceuticals, Inc. must provide training to healthcare providers who prescribe ULTOMIRIS and/or SOLIRIS.

The training includes the following educational materials: Healthcare Provider Safety Brochure, Patient Safety Card, and Patient Guide. The training must be available online and in hardcopy format via mail.

Alexion Pharmaceuticals, Inc. must provide training to healthcare settings and pharmacies that dispense ULTOMIRIS and/or SOLIRIS.

The training includes the following educational material: Healthcare Provider Safety Brochure. The training must be available online and in hardcopy format via mail.

To support REMS operations, Alexion Pharmaceuticals, Inc. must:

1. Distribute ULTOMIRIS and SOLIRIS only to certified healthcare settings and certified pharmacies.
2. Establish and maintain the REMS Website, www.UltSolREMS.com. The REMS Website must include the capability to complete the prescriber, and healthcare setting and pharmacy certification and enrollment online, and the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS Website. The REMS Website must not link back to the promotional product website(s).
3. Make the REMS Website fully operational and all REMS materials available through the REMS Website and Call Center within 180 calendar days of the approval of the REMS modification (03/22/2024).
4. Establish and maintain a REMS Call Center at 1-888-765-4747.
5. Establish and maintain a validated, secure database of all certified prescribers, and certified healthcare settings and pharmacies in the ULTOMIRIS and SOLIRIS REMS, and patient-specific information on vaccination and antibacterial drug prophylaxis.
6. Ensure that healthcare settings and pharmacies are able to obtain authorization to dispense by phone or online.
7. Ensure that prescribers, healthcare settings, and pharmacies are able to enroll by fax, email, and online.
8. Ensure that prescribers, healthcare settings, and pharmacies, are able to report vaccination and antibacterial drug prophylaxis information online and by fax.
9. Ensure that prescribers, and healthcare settings and pharmacies are able to report adverse events suggestive of meningococcal infections by phone.
10. Ensure that once a report suggestive of meningococcal infection is received, Alexion Pharmaceuticals, Inc. will follow up with the healthcare providers to obtain all required data. This requirement does not affect Alexion Pharmaceuticals, Inc.’s other reporting and follow-up requirements under the FDA regulations.
11. Provide the Prescriber Enrollment Form, Healthcare Provider Safety Brochure, Patient Safety Card, Patient Guide, Medication Guide, and the ULTOMIRIS and SOLIRIS Prescribing Information to healthcare providers who (1) attempt to prescribe ULTOMIRIS or SOLIRIS and are not yet certified or (2) inquire about how to become certified.
12. Provide the Healthcare Setting and Pharmacy Enrollment Form and the Healthcare Provider Safety Brochure to healthcare settings and pharmacies that (1) attempt to order/dispense ULTOMIRIS or SOLIRIS and are not yet certified or (2) inquire about how to become certified.
13. Notify prescribers, and healthcare settings and pharmacies within 2 business days after they become certified in the REMS.
14. Provide certified prescribers access to a database of certified healthcare settings, pharmacies, and patient-specific information on vaccination and antibacterial drug prophylaxis.
15. Provide certified healthcare settings and pharmacies access to a database of certified prescribers and patient-specific information on vaccination and antibacterial drug prophylaxis.

To ensure REMS participants' compliance with the REMS, Alexion Pharmaceuticals, Inc. must:

16. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: ULTOMIRIS and SOLIRIS distribution and dispensing; certification of prescribers, and healthcare settings and pharmacies; patient-specific information on vaccination and antibacterial drug prophylaxis; and audits of REMS participants. These records must be readily available for FDA inspections.
17. Verify annually that the designated Authorized Representative name and contact information correspond to those of the current designated Authorized Representative for each healthcare setting and pharmacy. If different, then the healthcare setting or pharmacy must be required to re-certify with a new Authorized Representative.
18. Establish and maintain a plan for addressing noncompliance with REMS requirements.
19. Monitor prescribers, and healthcare settings and pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if noncompliance is identified, including de-certification.
20. Audit certified healthcare settings and pharmacies no later than 180 calendar days after they become certified and a representative sample of certified healthcare settings and pharmacies annually thereafter, to ensure that all processes and procedures are in place, functioning, and comply with the REMS requirements.
21. Take reasonable steps to improve operations of and compliance with the requirements of the ULTOMIRIS and SOLIRIS REMS based on monitoring and evaluation of the ULTOMIRIS and SOLIRIS REMS.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Alexion Pharmaceuticals, Inc. must submit REMS Assessments annually from the date of the approval of the ULTOMIRIS and SOLIRIS REMS (03/22/2024). To facilitate inclusion of as much information as possible, while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Alexion Pharmaceuticals, Inc. must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS MATERIAL

The following materials are part of the ULTOMIRIS and SOLIRIS REMS:

Enrollment Forms

Prescriber:

1. Prescriber Enrollment Form

Healthcare Setting and Pharmacy:

2. Healthcare Setting and Pharmacy Enrollment Form

Training and Educational Materials

Prescriber:

3. Healthcare Provider Safety Brochure

Patient:

4. Patient Safety Card

5. Patient Guide

Healthcare Setting and Pharmacy:

6. Healthcare Provider Safety Brochure

Other Materials

7. REMS Website (www.UltSolREMS.com)

VI. Statutory Elements

REMS ELEMENTS

This REMS is required under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Elements to Assure Safe Use:
    • Healthcare providers who prescribe ULTOMIRIS and/or SOLIRIS are specially certified under 505-1(f)(3)(A)
    • Healthcare settings and pharmacies that dispense ULTOMIRIS and/or SOLIRIS are specially certified under 505-1(f)(3)(B)
    • ULTOMIRIS and SOLIRIS are dispensed to patients with evidence or other documentation of safe-use conditions under 505-1(f)(3)(D)
  2. Implementation System
  3. Timetable for Submission of Assessments

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fd421817-98f6-4a57-87da-64fa00361661Product name120250616
1944fe02-2140-486a-967c-ad54bb2a479aProduct name120171212

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

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DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use SOLIRIS safely and effectively. See full prescribing information for SOLIRIS. SOLIRIS ® (eculizumab) injection, for intravenous use Initial U.S. Approval: 2007SPL related document2026-07-08Alexion Pharmaceuticals Inc.20250716_cac0b2fd-919f-4505-99d4-ac6d9af299fe.zip!92457717-8f91-4727-af60-3daff7a7da94.xml
These highlights do not include all the information needed to use ULTOMIRIS safely and effectively. See full prescribing information for ULTOMIRIS. ULTOMIRIS ® (ravulizumab-cwvz) injection, for intravenous use Initial U.S. Approval: 2018SPL related document2025-10-09Alexion Pharmaceuticals Inc.20250716_cac0b2fd-919f-4505-99d4-ac6d9af299fe.zip!92457717-8f91-4727-af60-3daff7a7da94.xml
ff37319e-4ac2-4441-b1ae-b48cf7069ac4SPL related document120250716_cac0b2fd-919f-4505-99d4-ac6d9af299fe.zip!92457717-8f91-4727-af60-3daff7a7da94.xml
45f1a422-07f3-410e-ae64-c8e15e6e3a1bSPL related document120250716_cac0b2fd-919f-4505-99d4-ac6d9af299fe.zip!92457717-8f91-4727-af60-3daff7a7da94.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOLIRISECULIZUMABAlexion Pharmaceuticals Inc.ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c7222026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SOLIRIS

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