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To mitigate the occurrence and morbidity associated with meningococcal infections
To educate healthcare providers and patients regarding:
the increased risk of meningococcal infections with ULTOMIRIS
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.
Enroll in the REMS by completing the Prescriber Enrollment
Form and submitting it to the REMS Program.
| Prescriber Enrollment Form |
Before treatment initiation at
least 2 weeks prior to first
dose
Assess the patient’s meningococcal vaccine status and
immunize patients.
Provide the patient with a prescription for a 2-week course
of antibiotic prophylaxis if ULTOMIRIS 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 Brochure |
| Patient Safety Card |
During treatment
Assess the patient for early signs of meningococcal infection
and evaluate immediately, if infection is suspected.
Consider discontinuation of ULTOMIRIS in patients who
are undergoing treatment for serious meningococcal
infection.
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 ULTOMIRIS:
Before treatment initiation, at
least 2 weeks prior to the
first dose
Get meningococcal vaccines as directed by your doctor.
Take antibiotics as directed by your doctor for two weeks
after you get your vaccine if you have to start ULTOMIRIS
right away.
Get meningococcal vaccines as directed by your doctor.
At all times
Inform the prescriber or get emergency medical 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.
At all times during treatment
and for 8 months after the last
dose
Have the Patient Safety Card with you
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 Ultomiris REMS, see the DailyMed link(s).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
08/03/2022
Revised to reflect editorial change.
07/22/2022
Modified 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 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 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 to make changes to the Prescriber Enrollment Form to include the prescriber specialty and reformat this form
from two pages to one page.
10/18/2019
Modified to reflect changes to the Prescriber Safety Brochure including adding the
new indication.
12/21/2018
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.
