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The goal of the ULTOMIRIS and SOLIRIS REMS is to mitigate the risk of serious meningococcal infections.
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.
Patients are aware of early signs and symptoms of meningococcal infection and the need for
immediate medical evaluation.
Prescribers are aware of early signs and symptoms of meningococcal infection and the need
for immediate medical evaluation.
What do participants need to know?
Healthcare providers who prescribe ULTOMIRIS and/or SOLIRIS must:
Enroll by completing and submitting the Prescriber Enrollment Form
to the REMS.
| Prescriber Enrollment Form |
Before treatment initiation
Assess the patient for unresolved meningococcal infection.
For patients with an unresolved serious meningococcal infection: Not
initiate ULTOMIRIS or SOLIRIS.
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.
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.
Counsel the patient using the Patient Safety Card and Patient Guide.
Provide a copy of the materials to the patient.
| Patient Safety Card |
| Patient Guide |
Counsel the patient on the need to carry the Patient Safety Card.
| Patient Safety Card |
During treatment
Assess the patient for early signs and symptoms of meningococcal
infection and evaluate immediately if infection is suspected.
Vaccinate patients as needed according to the current ACIP
recommendations for meningococcal vaccinations for patients
receiving a complement inhibitor.
At all times
Report adverse events suggestive of meningococcal infection,
including the patient’s clinical outcomes, to Alexion Pharmaceuticals,
Inc.
Patients who are prescribed ULTOMIRIS or SOLIRIS:
Before treatment initiation
Get meningococcal vaccines for serogroups A, C, W, Y, and B as
directed by your prescriber.
Take antibiotics as directed by your prescriber if you have to start
ULTOMIRIS or SOLIRIS right away.
Receive counseling from your prescriber using the Patient Safety
Card and Patient Guide.
| Patient Safety Card |
| Patient Guide |
Get the Patient Safety Card and Patient Guide from your prescriber.
During treatment
Get additional meningococcal vaccines as directed by your
prescriber.
At all times during treatment and for 3 months after the last SOLIRIS dose
For SOLIRIS patients: Have the Patient Safety Card with you.
| Patient Safety Card |
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 flulike
symptoms.
At all times during treatment and for 8 months after the last
ULTOMIRIS dose
For ULTOMIRIS patients: Have the Patient Safety Card with you.
| Patient Safety Card |
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.
Healthcare settings and pharmacies that dispense ULTOMIRIS and/or SOLIRIS must:
To become certified to dispense
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.
Train all relevant staff involved in dispensing ULTOMIRIS and
SOLIRIS using the Healthcare Provider Safety Brochure.
| Healthcare Provider Safety Brochure |
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.
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 dose
Obtain authorization to dispense each prescription by contacting the
REMS to verify the prescriber is certified.
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 dose
Obtain authorization to dispense each prescription by contacting the
REMS to verify the prescriber is certified.
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 thereafter
Obtain authorization to dispense each prescription by contacting the
REMS to verify the prescriber is certified.
To maintain certification to dispense
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.
| Healthcare Setting and Pharmacy Enrollment Form |
At all times
Report adverse events suggestive of meningococcal infections to
Alexion Pharmaceuticals, Inc.
Not distribute, transfer, loan, or sell ULTOMIRIS or SOLIRIS, except
to other certified healthcare settings or certified pharmacies.
Maintain records of staff’s completion of REMS training.
Maintain records that all processes and procedures are in place and
are being followed.
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.
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.
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.
